FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book...

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Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote December 2016 Page 1 of 50 ACAMPROSATE CALCIUM TABLET, DELAYED RELEASE;ORAL CAMPRAL DISC FOREST LABS 333MG N 021431 001 Apr 04, 2016 Current OB:YES ACETAMINOPHEN; BUTALBITAL TABLET;ORAL PHRENILIN DISC VALEANT 325MG;50MG A 087811 001 Sep 06, 2016 Current OB:YES ACETAMINOPHEN; BUTALBITAL; CAFFEINE CAPSULE;ORAL BUTALIBITAL, ACETAMINOPHEN AND CAFFEINE DISC GILBERT LABS 325MG;50MG;40MG A 088825 001 Sep 06, 2016 Current OB:YES ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE DISC KV PHARM 325MG;45MG A 085363 001 Jul 02, 1996 Current OB:YES DISC ROXANE 500MG;15MG A 089511 001 May 07, 2002 Current OB:NO DISC 500MG;30MG A 089512 001 May 07, 2002 Current OB:NO DISC 500MG;60MG A 089513 001 May 07, 2002 Current OB:NO TYLENOL W/ CODEINE DISC ORTHO MCNEIL PHARM 325MG;7.5MG A 085056 001 Nov 25, 2015 Current OB:YES DISC 325MG;15MG A 085056 002 Nov 25, 2015 Current OB:YES DISC 325MG;30MG A 085056 003 Nov 25, 2015 Current OB:YES DISC 325MG;60MG A 085056 004 Nov 25, 2015 Current OB:YES ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL NORCO RX APIL 325MG;5MG A 040099 001 Mar 28, 2000 Current OB:NO ACETAZOLAMIDE TABLET;ORAL DIAMOX DISC TEVA BRANDED PHARM 125MG N 008943 001 Oct 21, 2014 Current OB:YES DISC 250MG N 008943 002 Oct 21, 2014 Current OB:YES ACETAZOLAMIDE SODIUM INJECTABLE;INJECTION DIAMOX DISC TEVA WOMENS EQ 500MG BASE/VIAL N 009388 001 Oct 21, 2014 Current OB:YES ACETYLCYSTEINE SOLUTION;INHALATION, ORAL MUCOMYST DISC APOTHECON 10% N 013601 002 Nov 12, 2013 Current OB:YES DISC 20% N 013601 001 Nov 12, 2013 Current OB:YES ACYCLOVIR TABLET;ORAL ACYCLOVIR DISC TEVA 200MG A 074556 001 Jul 31, 1998 Current OB:YES ACYCLOVIR SODIUM INJECTABLE;INJECTION ZOVIRAX DISC GLAXOSMITHKLINE EQ 1GM BASE/VIAL N 018603 002 Apr 11, 2014 Current OB:YES DISC EQ 250MG BASE/VIAL N 018603 003 Apr 11, 2014 Current OB:YES DISC EQ 500MG BASE/VIAL N 018603 001 Apr 11, 2014 Current OB:YES

Transcript of FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book...

Page 1: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 1 of 50

ACAMPROSATE CALCIUMTABLET DELAYED RELEASEORALCAMPRAL

DISC FOREST LABS 333MG N 021431 001 Apr 04 2016 Current OBYES

ACETAMINOPHEN BUTALBITALTABLETORALPHRENILIN

DISC VALEANT 325MG50MG A 087811 001 Sep 06 2016 Current OBYES

ACETAMINOPHEN BUTALBITAL CAFFEINECAPSULEORALBUTALIBITAL ACETAMINOPHEN AND CAFFEINE

DISC GILBERT LABS 325MG50MG40MG A 088825 001 Sep 06 2016 Current OBYES

ACETAMINOPHEN CODEINE PHOSPHATETABLETORALACETAMINOPHEN AND CODEINE PHOSPHATE

DISC KV PHARM 325MG45MG A 085363 001 Jul 02 1996 Current OBYESDISC ROXANE 500MG15MG A 089511 001 May 07 2002 Current OBNODISC 500MG30MG A 089512 001 May 07 2002 Current OBNODISC 500MG60MG A 089513 001 May 07 2002 Current OBNO

TYLENOL W CODEINEDISC ORTHO MCNEIL PHARM 325MG75MG A 085056 001 Nov 25 2015 Current OBYESDISC 325MG15MG A 085056 002 Nov 25 2015 Current OBYESDISC 325MG30MG A 085056 003 Nov 25 2015 Current OBYESDISC 325MG60MG A 085056 004 Nov 25 2015 Current OBYES

ACETAMINOPHEN HYDROCODONE BITARTRATETABLETORALNORCO

RX APIL 325MG5MG A 040099 001 Mar 28 2000 Current OBNO

ACETAZOLAMIDETABLETORALDIAMOX

DISC TEVA BRANDED PHARM 125MG N 008943 001 Oct 21 2014 Current OBYESDISC 250MG N 008943 002 Oct 21 2014 Current OBYES

ACETAZOLAMIDE SODIUMINJECTABLEINJECTIONDIAMOX

DISC TEVA WOMENS EQ 500MG BASEVIAL N 009388 001 Oct 21 2014 Current OBYES

ACETYLCYSTEINESOLUTIONINHALATION ORALMUCOMYST

DISC APOTHECON 10 N 013601 002 Nov 12 2013 Current OBYESDISC 20 N 013601 001 Nov 12 2013 Current OBYES

ACYCLOVIRTABLETORALACYCLOVIR

DISC TEVA 200MG A 074556 001 Jul 31 1998 Current OBYES

ACYCLOVIR SODIUMINJECTABLEINJECTIONZOVIRAX

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL N 018603 002 Apr 11 2014 Current OBYESDISC EQ 250MG BASEVIAL N 018603 003 Apr 11 2014 Current OBYESDISC EQ 500MG BASEVIAL N 018603 001 Apr 11 2014 Current OBYES

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ADAPALENESOLUTIONTOPICALDIFFERIN

DISC GALDERMA LABS LP 01 N 020338 001 Jan 31 2013 Current OBYES

ADENOSINESOLUTIONIV (INFUSION)ADENOSCAN

DISC ASTELLAS 60MG20ML (3MGML) N 020059 001 Sep 06 2016 Current OBYESDISC 90MG30ML (3MGML) N 020059 002 Sep 06 2016 Current OBYES

ALBUTEROL SULFATESOLUTIONINHALATIONALBUTEROL SULFATE

DISC MYLAN SPECLT EQ 0083 BASE A 072652 001 Sep 06 2016 Current OBYESPROVENTIL

DISC SCHERING EQ 0083 BASE N 019243 002 May 23 2007 Current OBYESDISC EQ 05 BASE N 019243 001 May 23 2007 Current OBYES

VENTOLINDISC GLAXOSMITHKLINE EQ 0083 BASE N 019773 001 Sep 06 2016 Current OBYESDISC EQ 05 BASE N 019269 002 Apr 04 2003 Current OBYESSYRUPORALPROVENTIL

DISC SCHERING EQ 2MG BASE5ML N 018062 001 Apr 28 2008 Current OBYESTABLETORALPROVENTIL

DISC SCHERING EQ 2MG BASE N 017853 001 Jun 06 2016 Current OBYESDISC EQ 4MG BASE N 017853 002 Jun 06 2016 Current OBYES

ALBUTEROL SULFATE IPRATROPIUM BROMIDESOLUTIONINHALATIONDUONEB

DISC MYLAN SPECLT EQ 0083 BASE0017 N 020950 001 Nov 18 2016 Current OBYES

ALCLOMETASONE DIPROPIONATECREAMTOPICALACLOVATE

DISC FOUGERA PHARMS 005 N 018707 001 Jul 20 2015 Current OBYESOINTMENTTOPICALACLOVATE

DISC FOUGERA PHARMS 005 N 018702 001 Jul 20 2015 Current OBYES

ALENDRONATE SODIUMTABLETORALFOSAMAX

DISC MERCK AND CO INC EQ 5MG BASE N 020560 003 Aug 14 2014 Current OBYESDISC EQ 10MG BASE N 020560 001 Aug 14 2014 Current OBYESDISC EQ 35MG BASE N 020560 004 Aug 14 2014 Current OBYESDISC EQ 40MG BASE N 020560 002 Aug 14 2014 Current OBYES

ALPRAZOLAMTABLET ORALLY DISINTEGRATINGORALNIRAVAM

DISC UCB INC 025MG N 021726 001 Jan 09 2015 Current OBYESDISC 05MG N 021726 002 Jan 09 2015 Current OBYESDISC 1MG N 021726 003 Jan 09 2015 Current OBYESDISC 2MG N 021726 004 Jan 09 2015 Current OBYES

AMANTADINE HYDROCHLORIDECAPSULEORALSYMMETREL

DISC ENDO PHARMS 100MG N 016020 001 Apr 04 2016 Current OBYES

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TABLETORAL

SYMMETREL

DISC ENDO PHARMS 100MG N 018101 001 Mar 02 2011 Current OBYES

AMIKACIN SULFATE

INJECTABLEINJECTION

AMIKIN

DISC

DISC

APOTHECON EQ 50MG BASEML

EQ 250MG BASEML

N 050495 001 Oct 30 2015 Current OBYES

N 050495 002 Oct 30 2015 Current OBYES

AMILORIDE HYDROCHLORIDE

TABLETORAL

MIDAMOR

RX PADDOCK LLC 5MG N 018200 001 Apr 28 2008 Current OBNO

AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE

TABLETORAL

MODURETIC 5-50

DISC MERCK EQ 5MG ANHYDROUS50MG N 018201 001 Apr 28 2008 Current OBYES

AMINOCAPROIC ACID

INJECTABLEINJECTION

AMICAR

DISC CLOVER PHARMS 250MGML N 015229 002 May 14 2009 Current OBYES

AMIODARONE HYDROCHLORIDE

INJECTABLEINJECTION

CORDARONE

DISC WYETH PHARMS INC 50MGML N 020377 001 Oct 01 2008 Current OBYES

AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE

TABLETORAL

LIMBITROL

DISC HERITAGE PHARMS

INC

EQ 125MG BASE5MG N 016949 001 Sep 27 2012 Current OBNO

LIMBITROL DS

DISC HERITAGE PHARMS

INC

EQ 25MG BASE10MG N 016949 002 Sep 27 2012 Current OBYES

AMMONIUM LACTATE

CREAMTOPICAL

LAC-HYDRIN

DISC RANBAXY EQ 12 BASE N 020508 001 Nov 18 2016 Current OBYES

LOTIONTOPICAL

LAC-HYDRIN

DISC RANBAXY EQ 12 BASE N 019155 001 Nov 18 2016 Current OBYES

AMOXICILLIN

CAPSULEORAL

AMOXIL

GLAXOSMITHKLINEDISC

DISC

FOR SUSPENSIONORAL

AMOXIL

250MG

500MG

N 050459 001 Sep 06 2016 Current OBYES

N 050459 002 Sep 06 2016 Current OBYES

GLAXOSMITHKLINEDISC

DISC

DISC

LAROTID

50MGML

125MG5ML

250MG5ML

N 050460 005 Sep 06 2016 Current OBYES

N 050460 001 Sep 06 2016 Current OBYES

N 050460 002 Sep 06 2016 Current OBYES

GLAXOSMITHKLINEDISC 50MGML N 050460 006 Sep 06 2016 Current OBYES

AMOXICILLIN CLAVULANATE POTASSIUM

FOR SUSPENSIONORAL

AUGMENTIN 200

RX DR REDDYS LABS INC 200MG5MLEQ 285MG BASE5ML

AUGMENTIN 400

N 050725 001 Dec 07 2010 Current OBNO

RX DR REDDYS LABS INC 400MG5MLEQ 57MG BASE5ML N 050725 002 Dec 07 2010 Current OBNO

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FOR SUSPENSIONORALAUGMENTIN ES-600

RX DR REDDYS LABS INC 600MG5MLEQ 429MG BASE5ML N 050755 001 Dec 07 2010 Current OBNOTABLET CHEWABLEORALAUGMENTIN 125

DISC DR REDDYS LABS INC 125MGEQ 3125MG BASE N 050597 001 Dec 07 2010 Current OBYESAUGMENTIN 200

RX DR REDDYS LABS INC 200MGEQ 285MG BASE N 050726 001 Dec 07 2010 Current OBNOAUGMENTIN 250

DISC DR REDDYS LABS INC 250MGEQ 625MG BASE N 050597 002 Dec 07 2010 Current OBYESAUGMENTIN 400

RX DR REDDYS LABS INC 400MGEQ 57MG BASE N 050726 002 Dec 07 2010 Current OBNO

AMPHETAMINE ADIPATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE ADIPATE DEXTROAMPHETAMINE SULFATECAPSULEORALDELCOBESE

DISC TEVA 125MG125MG125MG125MG A 083564 001 Nov 10 2003 Current OBYES

DISC 25MG25MG25MG25MG A 083564 002 Nov 10 2003 Current OBYES

DISC 375MG375MG375MG375MG A 083564 003 Nov 10 2003 Current OBYES

DISC 5MG5MG5MG5MG A 083564 004 Nov 10 2003 Current OBYES

TABLETORAL

DELCOBESE

DISC TEVA 125MG125MG125MG125MG A 083563 004 Nov 10 2003 Current OBNO

DISC 25MG25MG25MG25MG A 083563 003 Nov 10 2003 Current OBNO

DISC 375MG375MG375MG375MG A 083563 002 Nov 10 2003 Current OBNO

DISC 5MG5MG5MG5MG A 083563 001 Nov 10 2003 Current OBNO

AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINESULFATETABLETORALADDERALL 10

DISC TEVA WOMENS 25MG25MG25MG25MG N 011522 007 Nov 12 2013 Current OBYESADDERALL 125

DISC TEVA WOMENS 3125MG3125MG3125MG3125MG N 011522 012 Nov 12 2013 Current OBYESADDERALL 15

DISC TEVA WOMENS 375MG375MG375MG375MG N 011522 013 Nov 12 2013 Current OBYESADDERALL 20

DISC TEVA WOMENS 5MG5MG5MG5MG N 011522 008 Nov 12 2013 Current OBYESADDERALL 30

DISC TEVA WOMENS 75MG75MG75MG75MG N 011522 010 Nov 12 2013 Current OBYESADDERALL 5

DISC TEVA WOMENS 125MG125MG125MG125MG N 011522 009 Nov 12 2013 Current OBYESADDERALL 75

DISC TEVA WOMENS 1875MG1875MG1875MG1875MG N 011522 011 Nov 12 2013 Current OBYES

AMPHETAMINE SULFATETABLETORALAMPHETAMINE SULFATE

DISC LANNETT 5MG A 083901 001 Nov 10 2010 Current OBNODISC 10MG A 083901 002 Nov 10 2010 Current OBNO

AMPRENAVIRSOLUTIONORALAGENERASE

DISC GLAXOSMITHKLINE 15MGML N 021039 001 Jul 22 2011 Current OBYES

ANAGRELIDE HYDROCHLORIDECAPSULEORALAGRYLIN

DISC SHIRE LLC EQ 1MG BASE N 020333 002 Oct 01 2008 Current OBYES

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ARDEPARIN SODIUMINJECTABLEINJECTIONNORMIFLO

DISC PHARMACIA AND 5000 UNITS05ML N 020227 002 May 23 2002 Current OBYESUPJOHN

DISC 10000 UNITS05ML N 020227 001 May 23 2002 Current OBYES

ARIPIPRAZOLESOLUTIONORALABILIFY

DISC OTSUKA 1MGML N 021713 001 Jun 23 2015 Current OBYESTABLET ORALLY DISINTEGRATINGORALABILIFY

DISC OTSUKA 20MG N 021729 004 Dec 03 2009 Current OBYESDISC 30MG N 021729 005 Dec 03 2009 Current OBYES

ARMODAFINILTABLETORALNUVIGIL

DISC CEPHALON 100MG N 021875 002 Jul 22 2011 Current OBYESRX 200MG N 021875 005 Jul 22 2011 Current OBNO

ASPIRIN BUTALBITAL CAFFEINETABLETORALFIORINAL

DISC ALLERGAN SALES LLC 325MG50MG40MG N 017534 003 Nov 18 2016 Current OBYES

ASPIRIN CAFFEINE ORPHENADRINE CITRATETABLETORALNORGESIC

DISC MEDICIS 385MG30MG25MG N 013416 003 Oct 30 2015 Current OBYESNORGESIC FORTE

DISC MEDICIS 770MG60MG50MG N 013416 004 Oct 30 2015 Current OBYES

ASPIRIN HYDROCODONE BITARTRATETABLETORALAZDONE

DISC SCHWARZ PHARMA 500MG5MG A 089420 001 Oct 05 2010 Current OBYES

ASPIRIN PENTAZOCINE HYDROCHLORIDETABLETORALTALWIN COMPOUND

DISC SANOFI AVENTIS US 325MGEQ 125MG BASE N 016891 001 Aug 30 2011 Current OBYES

ATAZANAVIR SULFATECAPSULEORALREYATAZ

DISC BRISTOL MYERS EQ 100MG BASE N 021567 001 Jan 06 2015 Current OBYESSQUIBB

ATENOLOLINJECTABLEINJECTIONTENORMIN

DISC ASTRAZENECA 05MGML N 019058 001 Dec 19 2008 Current OBYES

ATORVASTATIN CALCIUM EZETIMIBETABLETORALLIPTRUZET

DISC MERCK SHARP DOHME EQ 10MG BASE10MG N 200153 001 Nov 20 2015 Current OBYESDISC EQ 20MG BASE10MG N 200153 002 Nov 20 2015 Current OBYESDISC EQ 40MG BASE10MG N 200153 003 Nov 20 2015 Current OBYESDISC EQ 80MG BASE10MG N 200153 004 Nov 20 2015 Current OBYES

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ATOVAQUONETABLETORALMEPRON

DISC GLAXOSMITHKLINE 250MG N 020259 001 May 16 2007 Current OBYESLLC

ATRACURIUM BESYLATEINJECTABLEINJECTIONTRACRIUM

DISC HOSPIRA 10MGML N 018831 002 May 14 2009 Current OBYESTRACRIUM PRESERVATIVE FREE

DISC HOSPIRA 10MGML N 018831 001 May 14 2009 Current OBYES

AZATHIOPRINETABLETORALIMURAN

DISC SEBELA IRELAND LTD 25MG N 016324 002 Feb 20 2002 Current OBYES

AZATHIOPRINE SODIUMINJECTABLEINJECTIONIMURAN

DISC SEBELA IRELAND LTD EQ 100MG BASEVIAL N 017391 001 May 23 2007 Current OBYES

AZITHROMYCINCAPSULEORALZITHROMAX

DISC PFIZER EQ 250MG BASE N 050670 001 May 20 2005 Current OBYES

BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATEOINTMENTOPHTHALMICCORTISPORIN

DISC CASPER PHARMA LLC 400 UNITSGM1EQ 35MG N 050416 002 Mar 07 2008 Current OBYESBASEGM10000 UNITSGM

BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEOINTMENTOPHTHALMICNEOSPORIN

DISC CASPER PHARMA LLC 400 UNITSGMEQ 35MG N 050417 001 Oct 01 2008 Current OBYESBASEGM10000 UNITSGM

BACITRACIN ZINC POLYMYXIN B SULFATEOINTMENTOPHTHALMICPOLYSPORIN

DISC MONARCH PHARMS 500 UNITSGM10000 UNITSGM A 061229 001 Oct 01 2008 Current OBYES

BACLOFENTABLETORALLIORESAL

DISC NOVARTIS 10MG N 017851 001 Aug 06 2003 Current OBYESDISC 20MG N 017851 003 Aug 06 2003 Current OBYES

BENZONATATECAPSULEORALTESSALON

DISC PFIZER 200MG N 011210 003 Jul 20 2015 Current OBYES

BENZPHETAMINE HYDROCHLORIDETABLETORALDIDREX

DISC PHARMACIA AND 25MG N 012427 003 Mar 25 2010 Current OBYESUPJOHN

DISC 50MG N 012427 002 Dec 04 2015 Current OBYES

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BENZTROPINE MESYLATETABLETORALBENZTROPINE MESYLATE

DISC LANNETT HOLDINGS

INC

05MG A 088877 001 Nov 18 2016 Current OBYES

DISC 1MG A 088894 001 Nov 18 2016 Current OBYES

DISC 2MG A 088895 001 Nov 18 2016 Current OBYES

COGENTIN

DISC

DISC

DISC

MERCK 05MG

1MG

2MG

N 009193 004 Aug 06 2003 Current OBYES

N 009193 003 Aug 06 2003 Current OBYES

N 009193 002 Aug 06 2003 Current OBYES

BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE SOLUSPAN

RX MERCK SHARP DOHME 3MGMLEQ 3MG BASEML N 014602 001 Jan 12 2006 Current OBNO

BETAMETHASONE DIPROPIONATELOTIONTOPICALDIPROSONE

DISC SCHERING EQ 005 BASE N 017781 001 Nov 18 2016 Current OBYES

BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE

DISC SCHERING EQ 3MG BASEML N 017561 001 Jan 12 2006 Current OBYES

BETHANECHOL CHLORIDEINJECTABLEINJECTIONURECHOLINE

DISC ODYSSEY PHARMS 5MGML N 006536 001 Feb 21 2001 Current OBYESTABLETORALURECHOLINE

DISC ODYSSEY PHARMS 5MG N 006536 003 Feb 21 2001 Current OBYESDISC 10MG N 006536 002 Feb 21 2001 Current OBYESDISC 25MG N 006536 004 Feb 21 2001 Current OBYESDISC 50MG N 006536 005 Feb 21 2001 Current OBYES

BIMATOPROSTSOLUTIONDROPSOPHTHALMICLUMIGAN

DISC ALLERGAN 003 N 021275 001 Oct 31 2014 Current OBYES

BISACODYL POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDEFOR SOLUTION TABLET DELAYED RELEASEORALHALFLYTELY

DISC BRAINTREE 5MGNANA210GMNA074GMN N 021551 003 Jul 20 2015 Current OBYESA286GMNA56GM

BISMUTH SUBSALICYLATE METRONIDAZOLE TETRACYCLINE HYDROCHLORIDETABLET CHEWABLE TABLET CAPSULEORALHELIDAC

DISC SEBELA IRELAND LTD 2624MGNANANA250MGNAN N 050719 001 Jul 20 2015 Current OBYESANA500MG

BLEOMYCIN SULFATEINJECTABLEINJECTIONBLENOXANE

DISC BRISTOL MYERS EQ 15 UNITS BASEVIAL N 050443 001 Jan 21 2016 Current OBYESSQUIBB

DISC EQ 30 UNITS BASEVIAL N 050443 002 Jan 21 2016 Current OBYES

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BRETYLIUM TOSYLATEINJECTABLEINJECTIONBRETYLIUM TOSYLATE

DISC HOSPIRA 50MGML N 019030 001 Dec 19 2011 Current OBYES

BRIMONIDINE TARTRATESOLUTIONDROPSOPHTHALMICALPHAGAN

DISC ALLERGAN 02 N 020613 001 Jun 11 2003 Current OBYES

BROMFENAC SODIUMSOLUTIONDROPSOPHTHALMICBROMDAY

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 002 Dec 04 2015 Current OBYESINCXIBROM

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 001 May 13 2011 Current OBYESINC

BROMOCRIPTINE MESYLATECAPSULEORALPARLODEL

RX US PHARMS HOLDINGS EQ 5MG BASE N 017962 002 Sep 06 2016 Current OBYESI

BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDESYRUPORALDIMETANE-DX

DISC ROBINS AH 2MG5ML10MG5ML30MG5ML N 019279 001 May 04 2016 Current OBYES

BUMETANIDEINJECTABLEINJECTIONBUMEX

DISC VALIDUS PHARMS INC 025MGML N 018226 001 Sep 06 2007 Current OBYESTABLETORALBUMEX

RX VALIDUS PHARMS INC 05MG N 018225 002 Oct 30 2015 Current OBYESRX 1MG N 018225 001 Oct 30 2015 Current OBYESRX 2MG N 018225 003 Oct 30 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDETABLETSUBLINGUALSUBUTEX

DISC INDIVIOR INC EQ 2MG BASE N 020732 002 Feb 13 2015 Current OBYESDISC EQ 8MG BASE N 020732 003 Feb 13 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDETABLETSUBLINGUALSUBOXONE

DISC INDIVIOR INC EQ 2MG BASEEQ 05MG BASE N 020733 001 Jun 06 2013 Current OBYESDISC EQ 8MG BASEEQ 2MG BASE N 020733 002 Jun 06 2013 Current OBNO

BUSPIRONE HYDROCHLORIDETABLETORALBUSPAR

DISC

DISC

BRISTOL MYERS

SQUIBB

5MG

10MG

N 018731 001 Sep 06 2016 Current OBYES

N 018731 002 Oct 19 2010 Current OBYES

DISC 15MG N 018731 003 Oct 19 2010 Current OBYES

DISC 30MG N 018731 004 Oct 19 2010 Current OBYES

BUSPIRONE HYDROCHLORIDE

DISC IVAX SUB TEVA

PHARMS

5MG A 075385 001 Sep 06 2016 Current OBYES

DISC

DISC

10MG

15MG

A 075385 002 Sep 06 2016 Current OBYES

A 075385 003 Sep 06 2016 Current OBYES

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CABERGOLINE

TABLETORAL

DOSTINEX

DISC PHARMACIA AND

UPJOHN

05MG N 020664 001 Mar 11 2010 Current OBYES

CAFFEINE ERGOTAMINE TARTRATE

SUPPOSITORYRECTAL

CAFERGOT

DISC NOVARTIS 100MG2MG N 009000 002 Apr 28 2008 Current OBYES

CALCIPOTRIENE

OINTMENTTOPICAL

DOVONEX

LEO PHARMA ASDISC

SOLUTIONTOPICAL

DOVONEX

0005 N 020273 001 Mar 09 2010 Current OBYES

LEO PHARMDISC 0005 N 020611 001 Oct 31 2014 Current OBYES

CALCIUM ACETATE

TABLETORAL

PHOSLO

DISC FRESENIUS MEDCL 667MG N 019976 001 Aug 06 2007 Current OBYES

CALCIUM CARBONATE RISEDRONATE SODIUM

TABLET TABLETORAL

ACTONEL WITH CALCIUM (COPACKAGED)

WARNER CHILCOTT EQ 500MG BASENANA35MGDISC N 021823 001 Jul 07 2010 Current OBYES

CAPTOPRIL

TABLETORAL

CAPOTEN

DISC

DISC

DISC

DISC

DISC

DISC

DISC

PAR PHARM 125MG

25MG

375MG

50MG

75MG

100MG

150MG

N 018343 005 Oct 30 2015 Current OBYES

N 018343 002 Oct 30 2015 Current OBYES

N 018343 006 Jan 21 2016 Current OBYES

N 018343 001 Oct 30 2015 Current OBYES

N 018343 007 Jan 21 2016 Current OBYES

N 018343 003 Oct 30 2015 Current OBYES

N 018343 004 Jan 21 2016 Current OBYES

CAPTOPRIL HYDROCHLOROTHIAZIDE

TABLETORAL

CAPOZIDE 2515

APOTHECON 25MG15MGDISC

CAPOZIDE 2525

APOTHECON 25MG25MGDISC

CAPOZIDE 5015

APOTHECON 50MG15MGDISC

CAPOZIDE 5025

APOTHECON 50MG25MGDISC

N 018709 001 Jan 09 2015 Current OBYES

N 018709 002 Jan 09 2015 Current OBYES

N 018709 004 Jan 09 2015 Current OBYES

N 018709 003 Jan 09 2015 Current OBYES

CARBIDOPA LEVODOPA

TABLET ORALLY DISINTEGRATINGORAL

PARCOPA

DISC

DISC

DISC

UCB INC 10MG100MG

25MG100MG

25MG250MG

A 076699 001 Jan 09 2015 Current OBYES

A 076699 002 Jan 09 2015 Current OBYES

A 076699 003 Jan 09 2015 Current OBYES

CARBINOXAMINE MALEATE

ELIXIRORAL

CLISTIN

DISC MCNEIL 4MG5ML N 008955 001 Apr 10 2000 Current OBYES

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TABLETORALCLISTIN

DISC ORTHO MCNEIL PHARM 4MG N 008915 001 May 21 1998 Current OBYES

CARBOPLATININJECTABLEINJECTIONPARAPLATIN

DISC CORDEN PHARMA 50MGVIAL N 019880 001 Dec 19 2008 Current OBYESDISC 150MGVIAL N 019880 002 Dec 19 2008 Current OBYESDISC 450MGVIAL N 019880 003 Dec 19 2008 Current OBYESINJECTABLEIV (INFUSION)PARAPLATIN

DISC CORDENPHARMA 50MG5ML (10MGML) N 020452 001 Jun 15 2012 Current OBYESDISC 150MG15ML (10MGML) N 020452 002 Jun 15 2012 Current OBYESDISC 450MG45ML (10MGML) N 020452 003 Jun 15 2012 Current OBYESDISC 600MG60ML (10MGML) N 020452 004 Jun 15 2012 Current OBYES

CEFACLORCAPSULEORALCECLOR

DISC LILLY EQ 250MG BASE N 050521 001 Oct 01 2008 Current OBYESDISC EQ 500MG BASE N 050521 002 Oct 01 2008 Current OBYESFOR SUSPENSIONORALCECLOR

DISC LILLY EQ 125MG BASE5ML N 050522 001 Oct 01 2008 Current OBYESDISC EQ 250MG BASE5ML N 050522 002 Oct 01 2008 Current OBYES

CEFADROXILCEFADROXIL HEMIHYDRATECAPSULEORALDURICEF

DISC WARNER CHILCOTT EQ 500MG BASE N 050512 001 Mar 26 2007 Current OBYESFOR SUSPENSIONORALDURICEF

DISC WARNER CHILCOTT EQ 125MG BASE5ML N 050527 002 Mar 02 2011 Current OBYESDISC EQ 250MG BASE5ML N 050527 003 Mar 02 2011 Current OBYESDISC EQ 500MG BASE5ML N 050527 001 Mar 02 2011 Current OBYESTABLETORALDURICEF

DISC WARNER CHILCOTT EQ 1GM BASE N 050528 001 Mar 26 2007 Current OBYES

CEFAZOLIN SODIUMINJECTABLEINJECTIONANCEF

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL N 050461 003 Oct 30 2015 Current OBYESDISC EQ 5GM BASEVIAL N 050461 004 Mar 07 2008 Current OBYESDISC EQ 10GM BASEVIAL N 050461 005 Oct 30 2015 Current OBYESDISC EQ 250MG BASEVIAL N 050461 001 Mar 07 2008 Current OBYESDISC EQ 500MG BASEVIAL N 050461 002 Mar 07 2008 Current OBNO

CEFAZOLIN SODIUMDISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 064169 002 Oct 30 2015 Current OBYESDISC EQ 500MG BASEVIAL A 064169 001 Oct 30 2015 Current OBYES

CEFDINIRCAPSULEORALOMNICEF

DISC ABBVIE 300MG N 050739 001 Nov 18 2016 Current OBYESFOR SUSPENSIONORALOMNICEF

DISC ABBVIE 125MG5ML N 050749 001 Nov 18 2016 Current OBYESDISC 250MG5ML N 050749 002 Nov 18 2016 Current OBYES

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December 2016 Page 11 of 50

CEFIXIMEFOR SUSPENSIONORALSUPRAX

DISC LEDERLE 100MG5ML N 050622 001 Feb 18 2004 Current OBYESTABLETORALSUPRAX

DISC LEDERLE 200MG N 050621 001 Feb 18 2004 Current OBYESDISC 400MG N 050621 002 Feb 18 2004 Current OBYES

CEFMETAZOLE SODIUMINJECTABLEINJECTIONZEFAZONE

DISC PHARMACIA AND EQ 1GM BASEVIAL N 050637 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 2GM BASEVIAL N 050637 002 Mar 10 2014 Current OBYESZEFAZONE IN PLASTIC CONTAINER

DISC PHARMACIA AND EQ 20MG BASEML N 050683 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 40MG BASEML N 050683 002 Mar 10 2014 Current OBYES

CEFOTETAN DISODIUMINJECTABLEINJECTIONCEFOTAN

RX TELIGENT PHARMA EQ 1GM BASEVIAL N 050588 001 Jun 07 2007 Current OBNOINC

RX EQ 2GM BASEVIAL N 050588 002 Jun 07 2007 Current OBNO

CEFOXITIN SODIUMINJECTABLEINJECTIONCEFOXITIN

DISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 065012 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 065012 002 May 04 2016 Current OBYES

MEFOXINDISC MYLAN EQ 1GM BASEVIAL N 050517 001 Mar 11 2010 Current OBYES

INSTITUTIONALDISC EQ 2GM BASEVIAL N 050517 002 Mar 11 2010 Current OBYESDISC EQ 10GM BASEVIAL N 050517 003 Sep 06 2007 Current OBYES

CEFPODOXIME PROXETILFOR SUSPENSIONORALVANTIN

DISC PHARMACIA AND EQ 50MG BASE5ML N 050675 001 Jan 21 2016 Current OBYESUPJOHN

DISC EQ 100MG BASE5ML N 050675 002 Jan 21 2016 Current OBYES

CEFTRIAXONE SODIUMINJECTABLEINJECTIONROCEPHIN

DISC HOFFMANN LA ROCHE EQ 10GM BASEVIAL N 050585 005 Mar 15 2011 Current OBNOROCEPHIN W DEXTROSE IN PLASTIC CONTAINER

DISC HOFFMANN LA ROCHE EQ 10MG BASEML N 050624 001 Nov 18 2016 Current OBYESDISC EQ 20MG BASEML N 050624 002 Nov 18 2016 Current OBYESDISC EQ 40MG BASEML N 050624 003 Nov 18 2016 Current OBYESINJECTABLEINTRAMUSCULAR INTRAVENOUSROCEPHIN

DISC HOFFMANN LA ROCHE EQ 1GM BASEVIAL N 050585 003 Mar 15 2011 Current OBNODISC EQ 2GM BASEVIAL N 050585 004 Mar 15 2011 Current OBNODISC EQ 250MG BASEVIAL N 050585 001 Mar 15 2011 Current OBNODISC EQ 500MG BASEVIAL N 050585 002 Mar 15 2011 Current OBNO

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December 2016 Page 12 of 50

CEPHALEXINCAPSULEORALKEFLEX

DISC PRAGMA PHARMS LLC EQ 333MG BASE N 050405 004 Apr 12 2011 Current OBYESFOR SUSPENSIONORALCEPHALEXIN

DISC FACTA FARMA EQ 100MG BASEML A 062117 001 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML A 062117 002 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML A 062117 003 Mar 15 2016 Current OBYES

KEFLEXDISC PRAGMA PHARMS LLC EQ 100MG BASEML N 050406 003 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML N 050406 001 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML N 050406 002 Mar 15 2016 Current OBYES

CHENODIOLTABLETORALCHENIX

DISC SIGMA TAU 250MG N 018513 002 May 23 2007 Current OBYES

CHLOROTHIAZIDESUSPENSIONORALDIURIL

RX SALIX PHARMS 250MG5ML N 011870 001 May 23 2007 Current OBNOTABLETORALDIURIL

DISC OAK PHARMS AKORN 250MG N 011145 004 May 23 2007 Current OBYESDISC 500MG N 011145 002 May 23 2007 Current OBYES

CHLORPROMAZINESUPPOSITORYRECTALTHORAZINE

DISC GLAXOSMITHKLINE 25MG N 009149 024 Jun 15 2009 Current OBYESDISC 100MG N 009149 033 Jun 15 2009 Current OBYES

CHLORPROMAZINE HYDROCHLORIDECONCENTRATEORALTHORAZINE

DISC GLAXOSMITHKLINE 30MGML N 009149 032 Jun 15 2009 Current OBYESDISC 100MGML N 009149 043 Jun 15 2009 Current OBYESINJECTABLEINJECTIONTHORAZINE

DISC GLAXOSMITHKLINE 25MGML N 009149 011 Jun 15 2009 Current OBYESSYRUPORALTHORAZINE

DISC GLAXOSMITHKLINE 10MG5ML N 009149 022 Jun 15 2009 Current OBYESTABLETORALCHLORPROMAZINE HYDROCHLORIDE

DISC SANDOZ 10MG A 080439 001 Jan 21 2016 Current OBYESDISC 25MG A 080439 002 Jan 21 2016 Current OBYESDISC 50MG A 080439 003 Jan 21 2016 Current OBYESDISC 100MG A 080439 004 Jan 21 2016 Current OBYESDISC 200MG A 080439 005 Jan 21 2016 Current OBYES

THORAZINEDISC GLAXOSMITHKLINE 10MG N 009149 002 May 23 2007 Current OBYESDISC 25MG N 009149 007 May 23 2007 Current OBYESDISC 50MG N 009149 013 May 23 2007 Current OBYESDISC 100MG N 009149 018 May 23 2007 Current OBYESDISC 200MG N 009149 020 May 23 2007 Current OBYES

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December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

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December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

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December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

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December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

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DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

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December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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December 2016 Page 21 of 50

TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

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See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 2: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 2 of 50

ADAPALENESOLUTIONTOPICALDIFFERIN

DISC GALDERMA LABS LP 01 N 020338 001 Jan 31 2013 Current OBYES

ADENOSINESOLUTIONIV (INFUSION)ADENOSCAN

DISC ASTELLAS 60MG20ML (3MGML) N 020059 001 Sep 06 2016 Current OBYESDISC 90MG30ML (3MGML) N 020059 002 Sep 06 2016 Current OBYES

ALBUTEROL SULFATESOLUTIONINHALATIONALBUTEROL SULFATE

DISC MYLAN SPECLT EQ 0083 BASE A 072652 001 Sep 06 2016 Current OBYESPROVENTIL

DISC SCHERING EQ 0083 BASE N 019243 002 May 23 2007 Current OBYESDISC EQ 05 BASE N 019243 001 May 23 2007 Current OBYES

VENTOLINDISC GLAXOSMITHKLINE EQ 0083 BASE N 019773 001 Sep 06 2016 Current OBYESDISC EQ 05 BASE N 019269 002 Apr 04 2003 Current OBYESSYRUPORALPROVENTIL

DISC SCHERING EQ 2MG BASE5ML N 018062 001 Apr 28 2008 Current OBYESTABLETORALPROVENTIL

DISC SCHERING EQ 2MG BASE N 017853 001 Jun 06 2016 Current OBYESDISC EQ 4MG BASE N 017853 002 Jun 06 2016 Current OBYES

ALBUTEROL SULFATE IPRATROPIUM BROMIDESOLUTIONINHALATIONDUONEB

DISC MYLAN SPECLT EQ 0083 BASE0017 N 020950 001 Nov 18 2016 Current OBYES

ALCLOMETASONE DIPROPIONATECREAMTOPICALACLOVATE

DISC FOUGERA PHARMS 005 N 018707 001 Jul 20 2015 Current OBYESOINTMENTTOPICALACLOVATE

DISC FOUGERA PHARMS 005 N 018702 001 Jul 20 2015 Current OBYES

ALENDRONATE SODIUMTABLETORALFOSAMAX

DISC MERCK AND CO INC EQ 5MG BASE N 020560 003 Aug 14 2014 Current OBYESDISC EQ 10MG BASE N 020560 001 Aug 14 2014 Current OBYESDISC EQ 35MG BASE N 020560 004 Aug 14 2014 Current OBYESDISC EQ 40MG BASE N 020560 002 Aug 14 2014 Current OBYES

ALPRAZOLAMTABLET ORALLY DISINTEGRATINGORALNIRAVAM

DISC UCB INC 025MG N 021726 001 Jan 09 2015 Current OBYESDISC 05MG N 021726 002 Jan 09 2015 Current OBYESDISC 1MG N 021726 003 Jan 09 2015 Current OBYESDISC 2MG N 021726 004 Jan 09 2015 Current OBYES

AMANTADINE HYDROCHLORIDECAPSULEORALSYMMETREL

DISC ENDO PHARMS 100MG N 016020 001 Apr 04 2016 Current OBYES

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December 2016 Page 3 of 50

TABLETORAL

SYMMETREL

DISC ENDO PHARMS 100MG N 018101 001 Mar 02 2011 Current OBYES

AMIKACIN SULFATE

INJECTABLEINJECTION

AMIKIN

DISC

DISC

APOTHECON EQ 50MG BASEML

EQ 250MG BASEML

N 050495 001 Oct 30 2015 Current OBYES

N 050495 002 Oct 30 2015 Current OBYES

AMILORIDE HYDROCHLORIDE

TABLETORAL

MIDAMOR

RX PADDOCK LLC 5MG N 018200 001 Apr 28 2008 Current OBNO

AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE

TABLETORAL

MODURETIC 5-50

DISC MERCK EQ 5MG ANHYDROUS50MG N 018201 001 Apr 28 2008 Current OBYES

AMINOCAPROIC ACID

INJECTABLEINJECTION

AMICAR

DISC CLOVER PHARMS 250MGML N 015229 002 May 14 2009 Current OBYES

AMIODARONE HYDROCHLORIDE

INJECTABLEINJECTION

CORDARONE

DISC WYETH PHARMS INC 50MGML N 020377 001 Oct 01 2008 Current OBYES

AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE

TABLETORAL

LIMBITROL

DISC HERITAGE PHARMS

INC

EQ 125MG BASE5MG N 016949 001 Sep 27 2012 Current OBNO

LIMBITROL DS

DISC HERITAGE PHARMS

INC

EQ 25MG BASE10MG N 016949 002 Sep 27 2012 Current OBYES

AMMONIUM LACTATE

CREAMTOPICAL

LAC-HYDRIN

DISC RANBAXY EQ 12 BASE N 020508 001 Nov 18 2016 Current OBYES

LOTIONTOPICAL

LAC-HYDRIN

DISC RANBAXY EQ 12 BASE N 019155 001 Nov 18 2016 Current OBYES

AMOXICILLIN

CAPSULEORAL

AMOXIL

GLAXOSMITHKLINEDISC

DISC

FOR SUSPENSIONORAL

AMOXIL

250MG

500MG

N 050459 001 Sep 06 2016 Current OBYES

N 050459 002 Sep 06 2016 Current OBYES

GLAXOSMITHKLINEDISC

DISC

DISC

LAROTID

50MGML

125MG5ML

250MG5ML

N 050460 005 Sep 06 2016 Current OBYES

N 050460 001 Sep 06 2016 Current OBYES

N 050460 002 Sep 06 2016 Current OBYES

GLAXOSMITHKLINEDISC 50MGML N 050460 006 Sep 06 2016 Current OBYES

AMOXICILLIN CLAVULANATE POTASSIUM

FOR SUSPENSIONORAL

AUGMENTIN 200

RX DR REDDYS LABS INC 200MG5MLEQ 285MG BASE5ML

AUGMENTIN 400

N 050725 001 Dec 07 2010 Current OBNO

RX DR REDDYS LABS INC 400MG5MLEQ 57MG BASE5ML N 050725 002 Dec 07 2010 Current OBNO

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FOR SUSPENSIONORALAUGMENTIN ES-600

RX DR REDDYS LABS INC 600MG5MLEQ 429MG BASE5ML N 050755 001 Dec 07 2010 Current OBNOTABLET CHEWABLEORALAUGMENTIN 125

DISC DR REDDYS LABS INC 125MGEQ 3125MG BASE N 050597 001 Dec 07 2010 Current OBYESAUGMENTIN 200

RX DR REDDYS LABS INC 200MGEQ 285MG BASE N 050726 001 Dec 07 2010 Current OBNOAUGMENTIN 250

DISC DR REDDYS LABS INC 250MGEQ 625MG BASE N 050597 002 Dec 07 2010 Current OBYESAUGMENTIN 400

RX DR REDDYS LABS INC 400MGEQ 57MG BASE N 050726 002 Dec 07 2010 Current OBNO

AMPHETAMINE ADIPATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE ADIPATE DEXTROAMPHETAMINE SULFATECAPSULEORALDELCOBESE

DISC TEVA 125MG125MG125MG125MG A 083564 001 Nov 10 2003 Current OBYES

DISC 25MG25MG25MG25MG A 083564 002 Nov 10 2003 Current OBYES

DISC 375MG375MG375MG375MG A 083564 003 Nov 10 2003 Current OBYES

DISC 5MG5MG5MG5MG A 083564 004 Nov 10 2003 Current OBYES

TABLETORAL

DELCOBESE

DISC TEVA 125MG125MG125MG125MG A 083563 004 Nov 10 2003 Current OBNO

DISC 25MG25MG25MG25MG A 083563 003 Nov 10 2003 Current OBNO

DISC 375MG375MG375MG375MG A 083563 002 Nov 10 2003 Current OBNO

DISC 5MG5MG5MG5MG A 083563 001 Nov 10 2003 Current OBNO

AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINESULFATETABLETORALADDERALL 10

DISC TEVA WOMENS 25MG25MG25MG25MG N 011522 007 Nov 12 2013 Current OBYESADDERALL 125

DISC TEVA WOMENS 3125MG3125MG3125MG3125MG N 011522 012 Nov 12 2013 Current OBYESADDERALL 15

DISC TEVA WOMENS 375MG375MG375MG375MG N 011522 013 Nov 12 2013 Current OBYESADDERALL 20

DISC TEVA WOMENS 5MG5MG5MG5MG N 011522 008 Nov 12 2013 Current OBYESADDERALL 30

DISC TEVA WOMENS 75MG75MG75MG75MG N 011522 010 Nov 12 2013 Current OBYESADDERALL 5

DISC TEVA WOMENS 125MG125MG125MG125MG N 011522 009 Nov 12 2013 Current OBYESADDERALL 75

DISC TEVA WOMENS 1875MG1875MG1875MG1875MG N 011522 011 Nov 12 2013 Current OBYES

AMPHETAMINE SULFATETABLETORALAMPHETAMINE SULFATE

DISC LANNETT 5MG A 083901 001 Nov 10 2010 Current OBNODISC 10MG A 083901 002 Nov 10 2010 Current OBNO

AMPRENAVIRSOLUTIONORALAGENERASE

DISC GLAXOSMITHKLINE 15MGML N 021039 001 Jul 22 2011 Current OBYES

ANAGRELIDE HYDROCHLORIDECAPSULEORALAGRYLIN

DISC SHIRE LLC EQ 1MG BASE N 020333 002 Oct 01 2008 Current OBYES

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ARDEPARIN SODIUMINJECTABLEINJECTIONNORMIFLO

DISC PHARMACIA AND 5000 UNITS05ML N 020227 002 May 23 2002 Current OBYESUPJOHN

DISC 10000 UNITS05ML N 020227 001 May 23 2002 Current OBYES

ARIPIPRAZOLESOLUTIONORALABILIFY

DISC OTSUKA 1MGML N 021713 001 Jun 23 2015 Current OBYESTABLET ORALLY DISINTEGRATINGORALABILIFY

DISC OTSUKA 20MG N 021729 004 Dec 03 2009 Current OBYESDISC 30MG N 021729 005 Dec 03 2009 Current OBYES

ARMODAFINILTABLETORALNUVIGIL

DISC CEPHALON 100MG N 021875 002 Jul 22 2011 Current OBYESRX 200MG N 021875 005 Jul 22 2011 Current OBNO

ASPIRIN BUTALBITAL CAFFEINETABLETORALFIORINAL

DISC ALLERGAN SALES LLC 325MG50MG40MG N 017534 003 Nov 18 2016 Current OBYES

ASPIRIN CAFFEINE ORPHENADRINE CITRATETABLETORALNORGESIC

DISC MEDICIS 385MG30MG25MG N 013416 003 Oct 30 2015 Current OBYESNORGESIC FORTE

DISC MEDICIS 770MG60MG50MG N 013416 004 Oct 30 2015 Current OBYES

ASPIRIN HYDROCODONE BITARTRATETABLETORALAZDONE

DISC SCHWARZ PHARMA 500MG5MG A 089420 001 Oct 05 2010 Current OBYES

ASPIRIN PENTAZOCINE HYDROCHLORIDETABLETORALTALWIN COMPOUND

DISC SANOFI AVENTIS US 325MGEQ 125MG BASE N 016891 001 Aug 30 2011 Current OBYES

ATAZANAVIR SULFATECAPSULEORALREYATAZ

DISC BRISTOL MYERS EQ 100MG BASE N 021567 001 Jan 06 2015 Current OBYESSQUIBB

ATENOLOLINJECTABLEINJECTIONTENORMIN

DISC ASTRAZENECA 05MGML N 019058 001 Dec 19 2008 Current OBYES

ATORVASTATIN CALCIUM EZETIMIBETABLETORALLIPTRUZET

DISC MERCK SHARP DOHME EQ 10MG BASE10MG N 200153 001 Nov 20 2015 Current OBYESDISC EQ 20MG BASE10MG N 200153 002 Nov 20 2015 Current OBYESDISC EQ 40MG BASE10MG N 200153 003 Nov 20 2015 Current OBYESDISC EQ 80MG BASE10MG N 200153 004 Nov 20 2015 Current OBYES

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ATOVAQUONETABLETORALMEPRON

DISC GLAXOSMITHKLINE 250MG N 020259 001 May 16 2007 Current OBYESLLC

ATRACURIUM BESYLATEINJECTABLEINJECTIONTRACRIUM

DISC HOSPIRA 10MGML N 018831 002 May 14 2009 Current OBYESTRACRIUM PRESERVATIVE FREE

DISC HOSPIRA 10MGML N 018831 001 May 14 2009 Current OBYES

AZATHIOPRINETABLETORALIMURAN

DISC SEBELA IRELAND LTD 25MG N 016324 002 Feb 20 2002 Current OBYES

AZATHIOPRINE SODIUMINJECTABLEINJECTIONIMURAN

DISC SEBELA IRELAND LTD EQ 100MG BASEVIAL N 017391 001 May 23 2007 Current OBYES

AZITHROMYCINCAPSULEORALZITHROMAX

DISC PFIZER EQ 250MG BASE N 050670 001 May 20 2005 Current OBYES

BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATEOINTMENTOPHTHALMICCORTISPORIN

DISC CASPER PHARMA LLC 400 UNITSGM1EQ 35MG N 050416 002 Mar 07 2008 Current OBYESBASEGM10000 UNITSGM

BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEOINTMENTOPHTHALMICNEOSPORIN

DISC CASPER PHARMA LLC 400 UNITSGMEQ 35MG N 050417 001 Oct 01 2008 Current OBYESBASEGM10000 UNITSGM

BACITRACIN ZINC POLYMYXIN B SULFATEOINTMENTOPHTHALMICPOLYSPORIN

DISC MONARCH PHARMS 500 UNITSGM10000 UNITSGM A 061229 001 Oct 01 2008 Current OBYES

BACLOFENTABLETORALLIORESAL

DISC NOVARTIS 10MG N 017851 001 Aug 06 2003 Current OBYESDISC 20MG N 017851 003 Aug 06 2003 Current OBYES

BENZONATATECAPSULEORALTESSALON

DISC PFIZER 200MG N 011210 003 Jul 20 2015 Current OBYES

BENZPHETAMINE HYDROCHLORIDETABLETORALDIDREX

DISC PHARMACIA AND 25MG N 012427 003 Mar 25 2010 Current OBYESUPJOHN

DISC 50MG N 012427 002 Dec 04 2015 Current OBYES

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December 2016 Page 7 of 50

BENZTROPINE MESYLATETABLETORALBENZTROPINE MESYLATE

DISC LANNETT HOLDINGS

INC

05MG A 088877 001 Nov 18 2016 Current OBYES

DISC 1MG A 088894 001 Nov 18 2016 Current OBYES

DISC 2MG A 088895 001 Nov 18 2016 Current OBYES

COGENTIN

DISC

DISC

DISC

MERCK 05MG

1MG

2MG

N 009193 004 Aug 06 2003 Current OBYES

N 009193 003 Aug 06 2003 Current OBYES

N 009193 002 Aug 06 2003 Current OBYES

BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE SOLUSPAN

RX MERCK SHARP DOHME 3MGMLEQ 3MG BASEML N 014602 001 Jan 12 2006 Current OBNO

BETAMETHASONE DIPROPIONATELOTIONTOPICALDIPROSONE

DISC SCHERING EQ 005 BASE N 017781 001 Nov 18 2016 Current OBYES

BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE

DISC SCHERING EQ 3MG BASEML N 017561 001 Jan 12 2006 Current OBYES

BETHANECHOL CHLORIDEINJECTABLEINJECTIONURECHOLINE

DISC ODYSSEY PHARMS 5MGML N 006536 001 Feb 21 2001 Current OBYESTABLETORALURECHOLINE

DISC ODYSSEY PHARMS 5MG N 006536 003 Feb 21 2001 Current OBYESDISC 10MG N 006536 002 Feb 21 2001 Current OBYESDISC 25MG N 006536 004 Feb 21 2001 Current OBYESDISC 50MG N 006536 005 Feb 21 2001 Current OBYES

BIMATOPROSTSOLUTIONDROPSOPHTHALMICLUMIGAN

DISC ALLERGAN 003 N 021275 001 Oct 31 2014 Current OBYES

BISACODYL POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDEFOR SOLUTION TABLET DELAYED RELEASEORALHALFLYTELY

DISC BRAINTREE 5MGNANA210GMNA074GMN N 021551 003 Jul 20 2015 Current OBYESA286GMNA56GM

BISMUTH SUBSALICYLATE METRONIDAZOLE TETRACYCLINE HYDROCHLORIDETABLET CHEWABLE TABLET CAPSULEORALHELIDAC

DISC SEBELA IRELAND LTD 2624MGNANANA250MGNAN N 050719 001 Jul 20 2015 Current OBYESANA500MG

BLEOMYCIN SULFATEINJECTABLEINJECTIONBLENOXANE

DISC BRISTOL MYERS EQ 15 UNITS BASEVIAL N 050443 001 Jan 21 2016 Current OBYESSQUIBB

DISC EQ 30 UNITS BASEVIAL N 050443 002 Jan 21 2016 Current OBYES

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BRETYLIUM TOSYLATEINJECTABLEINJECTIONBRETYLIUM TOSYLATE

DISC HOSPIRA 50MGML N 019030 001 Dec 19 2011 Current OBYES

BRIMONIDINE TARTRATESOLUTIONDROPSOPHTHALMICALPHAGAN

DISC ALLERGAN 02 N 020613 001 Jun 11 2003 Current OBYES

BROMFENAC SODIUMSOLUTIONDROPSOPHTHALMICBROMDAY

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 002 Dec 04 2015 Current OBYESINCXIBROM

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 001 May 13 2011 Current OBYESINC

BROMOCRIPTINE MESYLATECAPSULEORALPARLODEL

RX US PHARMS HOLDINGS EQ 5MG BASE N 017962 002 Sep 06 2016 Current OBYESI

BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDESYRUPORALDIMETANE-DX

DISC ROBINS AH 2MG5ML10MG5ML30MG5ML N 019279 001 May 04 2016 Current OBYES

BUMETANIDEINJECTABLEINJECTIONBUMEX

DISC VALIDUS PHARMS INC 025MGML N 018226 001 Sep 06 2007 Current OBYESTABLETORALBUMEX

RX VALIDUS PHARMS INC 05MG N 018225 002 Oct 30 2015 Current OBYESRX 1MG N 018225 001 Oct 30 2015 Current OBYESRX 2MG N 018225 003 Oct 30 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDETABLETSUBLINGUALSUBUTEX

DISC INDIVIOR INC EQ 2MG BASE N 020732 002 Feb 13 2015 Current OBYESDISC EQ 8MG BASE N 020732 003 Feb 13 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDETABLETSUBLINGUALSUBOXONE

DISC INDIVIOR INC EQ 2MG BASEEQ 05MG BASE N 020733 001 Jun 06 2013 Current OBYESDISC EQ 8MG BASEEQ 2MG BASE N 020733 002 Jun 06 2013 Current OBNO

BUSPIRONE HYDROCHLORIDETABLETORALBUSPAR

DISC

DISC

BRISTOL MYERS

SQUIBB

5MG

10MG

N 018731 001 Sep 06 2016 Current OBYES

N 018731 002 Oct 19 2010 Current OBYES

DISC 15MG N 018731 003 Oct 19 2010 Current OBYES

DISC 30MG N 018731 004 Oct 19 2010 Current OBYES

BUSPIRONE HYDROCHLORIDE

DISC IVAX SUB TEVA

PHARMS

5MG A 075385 001 Sep 06 2016 Current OBYES

DISC

DISC

10MG

15MG

A 075385 002 Sep 06 2016 Current OBYES

A 075385 003 Sep 06 2016 Current OBYES

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December 2016 Page 9 of 50

CABERGOLINE

TABLETORAL

DOSTINEX

DISC PHARMACIA AND

UPJOHN

05MG N 020664 001 Mar 11 2010 Current OBYES

CAFFEINE ERGOTAMINE TARTRATE

SUPPOSITORYRECTAL

CAFERGOT

DISC NOVARTIS 100MG2MG N 009000 002 Apr 28 2008 Current OBYES

CALCIPOTRIENE

OINTMENTTOPICAL

DOVONEX

LEO PHARMA ASDISC

SOLUTIONTOPICAL

DOVONEX

0005 N 020273 001 Mar 09 2010 Current OBYES

LEO PHARMDISC 0005 N 020611 001 Oct 31 2014 Current OBYES

CALCIUM ACETATE

TABLETORAL

PHOSLO

DISC FRESENIUS MEDCL 667MG N 019976 001 Aug 06 2007 Current OBYES

CALCIUM CARBONATE RISEDRONATE SODIUM

TABLET TABLETORAL

ACTONEL WITH CALCIUM (COPACKAGED)

WARNER CHILCOTT EQ 500MG BASENANA35MGDISC N 021823 001 Jul 07 2010 Current OBYES

CAPTOPRIL

TABLETORAL

CAPOTEN

DISC

DISC

DISC

DISC

DISC

DISC

DISC

PAR PHARM 125MG

25MG

375MG

50MG

75MG

100MG

150MG

N 018343 005 Oct 30 2015 Current OBYES

N 018343 002 Oct 30 2015 Current OBYES

N 018343 006 Jan 21 2016 Current OBYES

N 018343 001 Oct 30 2015 Current OBYES

N 018343 007 Jan 21 2016 Current OBYES

N 018343 003 Oct 30 2015 Current OBYES

N 018343 004 Jan 21 2016 Current OBYES

CAPTOPRIL HYDROCHLOROTHIAZIDE

TABLETORAL

CAPOZIDE 2515

APOTHECON 25MG15MGDISC

CAPOZIDE 2525

APOTHECON 25MG25MGDISC

CAPOZIDE 5015

APOTHECON 50MG15MGDISC

CAPOZIDE 5025

APOTHECON 50MG25MGDISC

N 018709 001 Jan 09 2015 Current OBYES

N 018709 002 Jan 09 2015 Current OBYES

N 018709 004 Jan 09 2015 Current OBYES

N 018709 003 Jan 09 2015 Current OBYES

CARBIDOPA LEVODOPA

TABLET ORALLY DISINTEGRATINGORAL

PARCOPA

DISC

DISC

DISC

UCB INC 10MG100MG

25MG100MG

25MG250MG

A 076699 001 Jan 09 2015 Current OBYES

A 076699 002 Jan 09 2015 Current OBYES

A 076699 003 Jan 09 2015 Current OBYES

CARBINOXAMINE MALEATE

ELIXIRORAL

CLISTIN

DISC MCNEIL 4MG5ML N 008955 001 Apr 10 2000 Current OBYES

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December 2016 Page 10 of 50

TABLETORALCLISTIN

DISC ORTHO MCNEIL PHARM 4MG N 008915 001 May 21 1998 Current OBYES

CARBOPLATININJECTABLEINJECTIONPARAPLATIN

DISC CORDEN PHARMA 50MGVIAL N 019880 001 Dec 19 2008 Current OBYESDISC 150MGVIAL N 019880 002 Dec 19 2008 Current OBYESDISC 450MGVIAL N 019880 003 Dec 19 2008 Current OBYESINJECTABLEIV (INFUSION)PARAPLATIN

DISC CORDENPHARMA 50MG5ML (10MGML) N 020452 001 Jun 15 2012 Current OBYESDISC 150MG15ML (10MGML) N 020452 002 Jun 15 2012 Current OBYESDISC 450MG45ML (10MGML) N 020452 003 Jun 15 2012 Current OBYESDISC 600MG60ML (10MGML) N 020452 004 Jun 15 2012 Current OBYES

CEFACLORCAPSULEORALCECLOR

DISC LILLY EQ 250MG BASE N 050521 001 Oct 01 2008 Current OBYESDISC EQ 500MG BASE N 050521 002 Oct 01 2008 Current OBYESFOR SUSPENSIONORALCECLOR

DISC LILLY EQ 125MG BASE5ML N 050522 001 Oct 01 2008 Current OBYESDISC EQ 250MG BASE5ML N 050522 002 Oct 01 2008 Current OBYES

CEFADROXILCEFADROXIL HEMIHYDRATECAPSULEORALDURICEF

DISC WARNER CHILCOTT EQ 500MG BASE N 050512 001 Mar 26 2007 Current OBYESFOR SUSPENSIONORALDURICEF

DISC WARNER CHILCOTT EQ 125MG BASE5ML N 050527 002 Mar 02 2011 Current OBYESDISC EQ 250MG BASE5ML N 050527 003 Mar 02 2011 Current OBYESDISC EQ 500MG BASE5ML N 050527 001 Mar 02 2011 Current OBYESTABLETORALDURICEF

DISC WARNER CHILCOTT EQ 1GM BASE N 050528 001 Mar 26 2007 Current OBYES

CEFAZOLIN SODIUMINJECTABLEINJECTIONANCEF

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL N 050461 003 Oct 30 2015 Current OBYESDISC EQ 5GM BASEVIAL N 050461 004 Mar 07 2008 Current OBYESDISC EQ 10GM BASEVIAL N 050461 005 Oct 30 2015 Current OBYESDISC EQ 250MG BASEVIAL N 050461 001 Mar 07 2008 Current OBYESDISC EQ 500MG BASEVIAL N 050461 002 Mar 07 2008 Current OBNO

CEFAZOLIN SODIUMDISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 064169 002 Oct 30 2015 Current OBYESDISC EQ 500MG BASEVIAL A 064169 001 Oct 30 2015 Current OBYES

CEFDINIRCAPSULEORALOMNICEF

DISC ABBVIE 300MG N 050739 001 Nov 18 2016 Current OBYESFOR SUSPENSIONORALOMNICEF

DISC ABBVIE 125MG5ML N 050749 001 Nov 18 2016 Current OBYESDISC 250MG5ML N 050749 002 Nov 18 2016 Current OBYES

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December 2016 Page 11 of 50

CEFIXIMEFOR SUSPENSIONORALSUPRAX

DISC LEDERLE 100MG5ML N 050622 001 Feb 18 2004 Current OBYESTABLETORALSUPRAX

DISC LEDERLE 200MG N 050621 001 Feb 18 2004 Current OBYESDISC 400MG N 050621 002 Feb 18 2004 Current OBYES

CEFMETAZOLE SODIUMINJECTABLEINJECTIONZEFAZONE

DISC PHARMACIA AND EQ 1GM BASEVIAL N 050637 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 2GM BASEVIAL N 050637 002 Mar 10 2014 Current OBYESZEFAZONE IN PLASTIC CONTAINER

DISC PHARMACIA AND EQ 20MG BASEML N 050683 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 40MG BASEML N 050683 002 Mar 10 2014 Current OBYES

CEFOTETAN DISODIUMINJECTABLEINJECTIONCEFOTAN

RX TELIGENT PHARMA EQ 1GM BASEVIAL N 050588 001 Jun 07 2007 Current OBNOINC

RX EQ 2GM BASEVIAL N 050588 002 Jun 07 2007 Current OBNO

CEFOXITIN SODIUMINJECTABLEINJECTIONCEFOXITIN

DISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 065012 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 065012 002 May 04 2016 Current OBYES

MEFOXINDISC MYLAN EQ 1GM BASEVIAL N 050517 001 Mar 11 2010 Current OBYES

INSTITUTIONALDISC EQ 2GM BASEVIAL N 050517 002 Mar 11 2010 Current OBYESDISC EQ 10GM BASEVIAL N 050517 003 Sep 06 2007 Current OBYES

CEFPODOXIME PROXETILFOR SUSPENSIONORALVANTIN

DISC PHARMACIA AND EQ 50MG BASE5ML N 050675 001 Jan 21 2016 Current OBYESUPJOHN

DISC EQ 100MG BASE5ML N 050675 002 Jan 21 2016 Current OBYES

CEFTRIAXONE SODIUMINJECTABLEINJECTIONROCEPHIN

DISC HOFFMANN LA ROCHE EQ 10GM BASEVIAL N 050585 005 Mar 15 2011 Current OBNOROCEPHIN W DEXTROSE IN PLASTIC CONTAINER

DISC HOFFMANN LA ROCHE EQ 10MG BASEML N 050624 001 Nov 18 2016 Current OBYESDISC EQ 20MG BASEML N 050624 002 Nov 18 2016 Current OBYESDISC EQ 40MG BASEML N 050624 003 Nov 18 2016 Current OBYESINJECTABLEINTRAMUSCULAR INTRAVENOUSROCEPHIN

DISC HOFFMANN LA ROCHE EQ 1GM BASEVIAL N 050585 003 Mar 15 2011 Current OBNODISC EQ 2GM BASEVIAL N 050585 004 Mar 15 2011 Current OBNODISC EQ 250MG BASEVIAL N 050585 001 Mar 15 2011 Current OBNODISC EQ 500MG BASEVIAL N 050585 002 Mar 15 2011 Current OBNO

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December 2016 Page 12 of 50

CEPHALEXINCAPSULEORALKEFLEX

DISC PRAGMA PHARMS LLC EQ 333MG BASE N 050405 004 Apr 12 2011 Current OBYESFOR SUSPENSIONORALCEPHALEXIN

DISC FACTA FARMA EQ 100MG BASEML A 062117 001 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML A 062117 002 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML A 062117 003 Mar 15 2016 Current OBYES

KEFLEXDISC PRAGMA PHARMS LLC EQ 100MG BASEML N 050406 003 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML N 050406 001 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML N 050406 002 Mar 15 2016 Current OBYES

CHENODIOLTABLETORALCHENIX

DISC SIGMA TAU 250MG N 018513 002 May 23 2007 Current OBYES

CHLOROTHIAZIDESUSPENSIONORALDIURIL

RX SALIX PHARMS 250MG5ML N 011870 001 May 23 2007 Current OBNOTABLETORALDIURIL

DISC OAK PHARMS AKORN 250MG N 011145 004 May 23 2007 Current OBYESDISC 500MG N 011145 002 May 23 2007 Current OBYES

CHLORPROMAZINESUPPOSITORYRECTALTHORAZINE

DISC GLAXOSMITHKLINE 25MG N 009149 024 Jun 15 2009 Current OBYESDISC 100MG N 009149 033 Jun 15 2009 Current OBYES

CHLORPROMAZINE HYDROCHLORIDECONCENTRATEORALTHORAZINE

DISC GLAXOSMITHKLINE 30MGML N 009149 032 Jun 15 2009 Current OBYESDISC 100MGML N 009149 043 Jun 15 2009 Current OBYESINJECTABLEINJECTIONTHORAZINE

DISC GLAXOSMITHKLINE 25MGML N 009149 011 Jun 15 2009 Current OBYESSYRUPORALTHORAZINE

DISC GLAXOSMITHKLINE 10MG5ML N 009149 022 Jun 15 2009 Current OBYESTABLETORALCHLORPROMAZINE HYDROCHLORIDE

DISC SANDOZ 10MG A 080439 001 Jan 21 2016 Current OBYESDISC 25MG A 080439 002 Jan 21 2016 Current OBYESDISC 50MG A 080439 003 Jan 21 2016 Current OBYESDISC 100MG A 080439 004 Jan 21 2016 Current OBYESDISC 200MG A 080439 005 Jan 21 2016 Current OBYES

THORAZINEDISC GLAXOSMITHKLINE 10MG N 009149 002 May 23 2007 Current OBYESDISC 25MG N 009149 007 May 23 2007 Current OBYESDISC 50MG N 009149 013 May 23 2007 Current OBYESDISC 100MG N 009149 018 May 23 2007 Current OBYESDISC 200MG N 009149 020 May 23 2007 Current OBYES

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December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

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December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

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December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

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December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

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DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

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December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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See List Footnote

December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

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December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 3: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 3 of 50

TABLETORAL

SYMMETREL

DISC ENDO PHARMS 100MG N 018101 001 Mar 02 2011 Current OBYES

AMIKACIN SULFATE

INJECTABLEINJECTION

AMIKIN

DISC

DISC

APOTHECON EQ 50MG BASEML

EQ 250MG BASEML

N 050495 001 Oct 30 2015 Current OBYES

N 050495 002 Oct 30 2015 Current OBYES

AMILORIDE HYDROCHLORIDE

TABLETORAL

MIDAMOR

RX PADDOCK LLC 5MG N 018200 001 Apr 28 2008 Current OBNO

AMILORIDE HYDROCHLORIDE HYDROCHLOROTHIAZIDE

TABLETORAL

MODURETIC 5-50

DISC MERCK EQ 5MG ANHYDROUS50MG N 018201 001 Apr 28 2008 Current OBYES

AMINOCAPROIC ACID

INJECTABLEINJECTION

AMICAR

DISC CLOVER PHARMS 250MGML N 015229 002 May 14 2009 Current OBYES

AMIODARONE HYDROCHLORIDE

INJECTABLEINJECTION

CORDARONE

DISC WYETH PHARMS INC 50MGML N 020377 001 Oct 01 2008 Current OBYES

AMITRIPTYLINE HYDROCHLORIDE CHLORDIAZEPOXIDE

TABLETORAL

LIMBITROL

DISC HERITAGE PHARMS

INC

EQ 125MG BASE5MG N 016949 001 Sep 27 2012 Current OBNO

LIMBITROL DS

DISC HERITAGE PHARMS

INC

EQ 25MG BASE10MG N 016949 002 Sep 27 2012 Current OBYES

AMMONIUM LACTATE

CREAMTOPICAL

LAC-HYDRIN

DISC RANBAXY EQ 12 BASE N 020508 001 Nov 18 2016 Current OBYES

LOTIONTOPICAL

LAC-HYDRIN

DISC RANBAXY EQ 12 BASE N 019155 001 Nov 18 2016 Current OBYES

AMOXICILLIN

CAPSULEORAL

AMOXIL

GLAXOSMITHKLINEDISC

DISC

FOR SUSPENSIONORAL

AMOXIL

250MG

500MG

N 050459 001 Sep 06 2016 Current OBYES

N 050459 002 Sep 06 2016 Current OBYES

GLAXOSMITHKLINEDISC

DISC

DISC

LAROTID

50MGML

125MG5ML

250MG5ML

N 050460 005 Sep 06 2016 Current OBYES

N 050460 001 Sep 06 2016 Current OBYES

N 050460 002 Sep 06 2016 Current OBYES

GLAXOSMITHKLINEDISC 50MGML N 050460 006 Sep 06 2016 Current OBYES

AMOXICILLIN CLAVULANATE POTASSIUM

FOR SUSPENSIONORAL

AUGMENTIN 200

RX DR REDDYS LABS INC 200MG5MLEQ 285MG BASE5ML

AUGMENTIN 400

N 050725 001 Dec 07 2010 Current OBNO

RX DR REDDYS LABS INC 400MG5MLEQ 57MG BASE5ML N 050725 002 Dec 07 2010 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 4 of 50

FOR SUSPENSIONORALAUGMENTIN ES-600

RX DR REDDYS LABS INC 600MG5MLEQ 429MG BASE5ML N 050755 001 Dec 07 2010 Current OBNOTABLET CHEWABLEORALAUGMENTIN 125

DISC DR REDDYS LABS INC 125MGEQ 3125MG BASE N 050597 001 Dec 07 2010 Current OBYESAUGMENTIN 200

RX DR REDDYS LABS INC 200MGEQ 285MG BASE N 050726 001 Dec 07 2010 Current OBNOAUGMENTIN 250

DISC DR REDDYS LABS INC 250MGEQ 625MG BASE N 050597 002 Dec 07 2010 Current OBYESAUGMENTIN 400

RX DR REDDYS LABS INC 400MGEQ 57MG BASE N 050726 002 Dec 07 2010 Current OBNO

AMPHETAMINE ADIPATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE ADIPATE DEXTROAMPHETAMINE SULFATECAPSULEORALDELCOBESE

DISC TEVA 125MG125MG125MG125MG A 083564 001 Nov 10 2003 Current OBYES

DISC 25MG25MG25MG25MG A 083564 002 Nov 10 2003 Current OBYES

DISC 375MG375MG375MG375MG A 083564 003 Nov 10 2003 Current OBYES

DISC 5MG5MG5MG5MG A 083564 004 Nov 10 2003 Current OBYES

TABLETORAL

DELCOBESE

DISC TEVA 125MG125MG125MG125MG A 083563 004 Nov 10 2003 Current OBNO

DISC 25MG25MG25MG25MG A 083563 003 Nov 10 2003 Current OBNO

DISC 375MG375MG375MG375MG A 083563 002 Nov 10 2003 Current OBNO

DISC 5MG5MG5MG5MG A 083563 001 Nov 10 2003 Current OBNO

AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINESULFATETABLETORALADDERALL 10

DISC TEVA WOMENS 25MG25MG25MG25MG N 011522 007 Nov 12 2013 Current OBYESADDERALL 125

DISC TEVA WOMENS 3125MG3125MG3125MG3125MG N 011522 012 Nov 12 2013 Current OBYESADDERALL 15

DISC TEVA WOMENS 375MG375MG375MG375MG N 011522 013 Nov 12 2013 Current OBYESADDERALL 20

DISC TEVA WOMENS 5MG5MG5MG5MG N 011522 008 Nov 12 2013 Current OBYESADDERALL 30

DISC TEVA WOMENS 75MG75MG75MG75MG N 011522 010 Nov 12 2013 Current OBYESADDERALL 5

DISC TEVA WOMENS 125MG125MG125MG125MG N 011522 009 Nov 12 2013 Current OBYESADDERALL 75

DISC TEVA WOMENS 1875MG1875MG1875MG1875MG N 011522 011 Nov 12 2013 Current OBYES

AMPHETAMINE SULFATETABLETORALAMPHETAMINE SULFATE

DISC LANNETT 5MG A 083901 001 Nov 10 2010 Current OBNODISC 10MG A 083901 002 Nov 10 2010 Current OBNO

AMPRENAVIRSOLUTIONORALAGENERASE

DISC GLAXOSMITHKLINE 15MGML N 021039 001 Jul 22 2011 Current OBYES

ANAGRELIDE HYDROCHLORIDECAPSULEORALAGRYLIN

DISC SHIRE LLC EQ 1MG BASE N 020333 002 Oct 01 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 5 of 50

ARDEPARIN SODIUMINJECTABLEINJECTIONNORMIFLO

DISC PHARMACIA AND 5000 UNITS05ML N 020227 002 May 23 2002 Current OBYESUPJOHN

DISC 10000 UNITS05ML N 020227 001 May 23 2002 Current OBYES

ARIPIPRAZOLESOLUTIONORALABILIFY

DISC OTSUKA 1MGML N 021713 001 Jun 23 2015 Current OBYESTABLET ORALLY DISINTEGRATINGORALABILIFY

DISC OTSUKA 20MG N 021729 004 Dec 03 2009 Current OBYESDISC 30MG N 021729 005 Dec 03 2009 Current OBYES

ARMODAFINILTABLETORALNUVIGIL

DISC CEPHALON 100MG N 021875 002 Jul 22 2011 Current OBYESRX 200MG N 021875 005 Jul 22 2011 Current OBNO

ASPIRIN BUTALBITAL CAFFEINETABLETORALFIORINAL

DISC ALLERGAN SALES LLC 325MG50MG40MG N 017534 003 Nov 18 2016 Current OBYES

ASPIRIN CAFFEINE ORPHENADRINE CITRATETABLETORALNORGESIC

DISC MEDICIS 385MG30MG25MG N 013416 003 Oct 30 2015 Current OBYESNORGESIC FORTE

DISC MEDICIS 770MG60MG50MG N 013416 004 Oct 30 2015 Current OBYES

ASPIRIN HYDROCODONE BITARTRATETABLETORALAZDONE

DISC SCHWARZ PHARMA 500MG5MG A 089420 001 Oct 05 2010 Current OBYES

ASPIRIN PENTAZOCINE HYDROCHLORIDETABLETORALTALWIN COMPOUND

DISC SANOFI AVENTIS US 325MGEQ 125MG BASE N 016891 001 Aug 30 2011 Current OBYES

ATAZANAVIR SULFATECAPSULEORALREYATAZ

DISC BRISTOL MYERS EQ 100MG BASE N 021567 001 Jan 06 2015 Current OBYESSQUIBB

ATENOLOLINJECTABLEINJECTIONTENORMIN

DISC ASTRAZENECA 05MGML N 019058 001 Dec 19 2008 Current OBYES

ATORVASTATIN CALCIUM EZETIMIBETABLETORALLIPTRUZET

DISC MERCK SHARP DOHME EQ 10MG BASE10MG N 200153 001 Nov 20 2015 Current OBYESDISC EQ 20MG BASE10MG N 200153 002 Nov 20 2015 Current OBYESDISC EQ 40MG BASE10MG N 200153 003 Nov 20 2015 Current OBYESDISC EQ 80MG BASE10MG N 200153 004 Nov 20 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 6 of 50

ATOVAQUONETABLETORALMEPRON

DISC GLAXOSMITHKLINE 250MG N 020259 001 May 16 2007 Current OBYESLLC

ATRACURIUM BESYLATEINJECTABLEINJECTIONTRACRIUM

DISC HOSPIRA 10MGML N 018831 002 May 14 2009 Current OBYESTRACRIUM PRESERVATIVE FREE

DISC HOSPIRA 10MGML N 018831 001 May 14 2009 Current OBYES

AZATHIOPRINETABLETORALIMURAN

DISC SEBELA IRELAND LTD 25MG N 016324 002 Feb 20 2002 Current OBYES

AZATHIOPRINE SODIUMINJECTABLEINJECTIONIMURAN

DISC SEBELA IRELAND LTD EQ 100MG BASEVIAL N 017391 001 May 23 2007 Current OBYES

AZITHROMYCINCAPSULEORALZITHROMAX

DISC PFIZER EQ 250MG BASE N 050670 001 May 20 2005 Current OBYES

BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATEOINTMENTOPHTHALMICCORTISPORIN

DISC CASPER PHARMA LLC 400 UNITSGM1EQ 35MG N 050416 002 Mar 07 2008 Current OBYESBASEGM10000 UNITSGM

BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEOINTMENTOPHTHALMICNEOSPORIN

DISC CASPER PHARMA LLC 400 UNITSGMEQ 35MG N 050417 001 Oct 01 2008 Current OBYESBASEGM10000 UNITSGM

BACITRACIN ZINC POLYMYXIN B SULFATEOINTMENTOPHTHALMICPOLYSPORIN

DISC MONARCH PHARMS 500 UNITSGM10000 UNITSGM A 061229 001 Oct 01 2008 Current OBYES

BACLOFENTABLETORALLIORESAL

DISC NOVARTIS 10MG N 017851 001 Aug 06 2003 Current OBYESDISC 20MG N 017851 003 Aug 06 2003 Current OBYES

BENZONATATECAPSULEORALTESSALON

DISC PFIZER 200MG N 011210 003 Jul 20 2015 Current OBYES

BENZPHETAMINE HYDROCHLORIDETABLETORALDIDREX

DISC PHARMACIA AND 25MG N 012427 003 Mar 25 2010 Current OBYESUPJOHN

DISC 50MG N 012427 002 Dec 04 2015 Current OBYES

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December 2016 Page 7 of 50

BENZTROPINE MESYLATETABLETORALBENZTROPINE MESYLATE

DISC LANNETT HOLDINGS

INC

05MG A 088877 001 Nov 18 2016 Current OBYES

DISC 1MG A 088894 001 Nov 18 2016 Current OBYES

DISC 2MG A 088895 001 Nov 18 2016 Current OBYES

COGENTIN

DISC

DISC

DISC

MERCK 05MG

1MG

2MG

N 009193 004 Aug 06 2003 Current OBYES

N 009193 003 Aug 06 2003 Current OBYES

N 009193 002 Aug 06 2003 Current OBYES

BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE SOLUSPAN

RX MERCK SHARP DOHME 3MGMLEQ 3MG BASEML N 014602 001 Jan 12 2006 Current OBNO

BETAMETHASONE DIPROPIONATELOTIONTOPICALDIPROSONE

DISC SCHERING EQ 005 BASE N 017781 001 Nov 18 2016 Current OBYES

BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE

DISC SCHERING EQ 3MG BASEML N 017561 001 Jan 12 2006 Current OBYES

BETHANECHOL CHLORIDEINJECTABLEINJECTIONURECHOLINE

DISC ODYSSEY PHARMS 5MGML N 006536 001 Feb 21 2001 Current OBYESTABLETORALURECHOLINE

DISC ODYSSEY PHARMS 5MG N 006536 003 Feb 21 2001 Current OBYESDISC 10MG N 006536 002 Feb 21 2001 Current OBYESDISC 25MG N 006536 004 Feb 21 2001 Current OBYESDISC 50MG N 006536 005 Feb 21 2001 Current OBYES

BIMATOPROSTSOLUTIONDROPSOPHTHALMICLUMIGAN

DISC ALLERGAN 003 N 021275 001 Oct 31 2014 Current OBYES

BISACODYL POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDEFOR SOLUTION TABLET DELAYED RELEASEORALHALFLYTELY

DISC BRAINTREE 5MGNANA210GMNA074GMN N 021551 003 Jul 20 2015 Current OBYESA286GMNA56GM

BISMUTH SUBSALICYLATE METRONIDAZOLE TETRACYCLINE HYDROCHLORIDETABLET CHEWABLE TABLET CAPSULEORALHELIDAC

DISC SEBELA IRELAND LTD 2624MGNANANA250MGNAN N 050719 001 Jul 20 2015 Current OBYESANA500MG

BLEOMYCIN SULFATEINJECTABLEINJECTIONBLENOXANE

DISC BRISTOL MYERS EQ 15 UNITS BASEVIAL N 050443 001 Jan 21 2016 Current OBYESSQUIBB

DISC EQ 30 UNITS BASEVIAL N 050443 002 Jan 21 2016 Current OBYES

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December 2016 Page 8 of 50

BRETYLIUM TOSYLATEINJECTABLEINJECTIONBRETYLIUM TOSYLATE

DISC HOSPIRA 50MGML N 019030 001 Dec 19 2011 Current OBYES

BRIMONIDINE TARTRATESOLUTIONDROPSOPHTHALMICALPHAGAN

DISC ALLERGAN 02 N 020613 001 Jun 11 2003 Current OBYES

BROMFENAC SODIUMSOLUTIONDROPSOPHTHALMICBROMDAY

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 002 Dec 04 2015 Current OBYESINCXIBROM

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 001 May 13 2011 Current OBYESINC

BROMOCRIPTINE MESYLATECAPSULEORALPARLODEL

RX US PHARMS HOLDINGS EQ 5MG BASE N 017962 002 Sep 06 2016 Current OBYESI

BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDESYRUPORALDIMETANE-DX

DISC ROBINS AH 2MG5ML10MG5ML30MG5ML N 019279 001 May 04 2016 Current OBYES

BUMETANIDEINJECTABLEINJECTIONBUMEX

DISC VALIDUS PHARMS INC 025MGML N 018226 001 Sep 06 2007 Current OBYESTABLETORALBUMEX

RX VALIDUS PHARMS INC 05MG N 018225 002 Oct 30 2015 Current OBYESRX 1MG N 018225 001 Oct 30 2015 Current OBYESRX 2MG N 018225 003 Oct 30 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDETABLETSUBLINGUALSUBUTEX

DISC INDIVIOR INC EQ 2MG BASE N 020732 002 Feb 13 2015 Current OBYESDISC EQ 8MG BASE N 020732 003 Feb 13 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDETABLETSUBLINGUALSUBOXONE

DISC INDIVIOR INC EQ 2MG BASEEQ 05MG BASE N 020733 001 Jun 06 2013 Current OBYESDISC EQ 8MG BASEEQ 2MG BASE N 020733 002 Jun 06 2013 Current OBNO

BUSPIRONE HYDROCHLORIDETABLETORALBUSPAR

DISC

DISC

BRISTOL MYERS

SQUIBB

5MG

10MG

N 018731 001 Sep 06 2016 Current OBYES

N 018731 002 Oct 19 2010 Current OBYES

DISC 15MG N 018731 003 Oct 19 2010 Current OBYES

DISC 30MG N 018731 004 Oct 19 2010 Current OBYES

BUSPIRONE HYDROCHLORIDE

DISC IVAX SUB TEVA

PHARMS

5MG A 075385 001 Sep 06 2016 Current OBYES

DISC

DISC

10MG

15MG

A 075385 002 Sep 06 2016 Current OBYES

A 075385 003 Sep 06 2016 Current OBYES

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December 2016 Page 9 of 50

CABERGOLINE

TABLETORAL

DOSTINEX

DISC PHARMACIA AND

UPJOHN

05MG N 020664 001 Mar 11 2010 Current OBYES

CAFFEINE ERGOTAMINE TARTRATE

SUPPOSITORYRECTAL

CAFERGOT

DISC NOVARTIS 100MG2MG N 009000 002 Apr 28 2008 Current OBYES

CALCIPOTRIENE

OINTMENTTOPICAL

DOVONEX

LEO PHARMA ASDISC

SOLUTIONTOPICAL

DOVONEX

0005 N 020273 001 Mar 09 2010 Current OBYES

LEO PHARMDISC 0005 N 020611 001 Oct 31 2014 Current OBYES

CALCIUM ACETATE

TABLETORAL

PHOSLO

DISC FRESENIUS MEDCL 667MG N 019976 001 Aug 06 2007 Current OBYES

CALCIUM CARBONATE RISEDRONATE SODIUM

TABLET TABLETORAL

ACTONEL WITH CALCIUM (COPACKAGED)

WARNER CHILCOTT EQ 500MG BASENANA35MGDISC N 021823 001 Jul 07 2010 Current OBYES

CAPTOPRIL

TABLETORAL

CAPOTEN

DISC

DISC

DISC

DISC

DISC

DISC

DISC

PAR PHARM 125MG

25MG

375MG

50MG

75MG

100MG

150MG

N 018343 005 Oct 30 2015 Current OBYES

N 018343 002 Oct 30 2015 Current OBYES

N 018343 006 Jan 21 2016 Current OBYES

N 018343 001 Oct 30 2015 Current OBYES

N 018343 007 Jan 21 2016 Current OBYES

N 018343 003 Oct 30 2015 Current OBYES

N 018343 004 Jan 21 2016 Current OBYES

CAPTOPRIL HYDROCHLOROTHIAZIDE

TABLETORAL

CAPOZIDE 2515

APOTHECON 25MG15MGDISC

CAPOZIDE 2525

APOTHECON 25MG25MGDISC

CAPOZIDE 5015

APOTHECON 50MG15MGDISC

CAPOZIDE 5025

APOTHECON 50MG25MGDISC

N 018709 001 Jan 09 2015 Current OBYES

N 018709 002 Jan 09 2015 Current OBYES

N 018709 004 Jan 09 2015 Current OBYES

N 018709 003 Jan 09 2015 Current OBYES

CARBIDOPA LEVODOPA

TABLET ORALLY DISINTEGRATINGORAL

PARCOPA

DISC

DISC

DISC

UCB INC 10MG100MG

25MG100MG

25MG250MG

A 076699 001 Jan 09 2015 Current OBYES

A 076699 002 Jan 09 2015 Current OBYES

A 076699 003 Jan 09 2015 Current OBYES

CARBINOXAMINE MALEATE

ELIXIRORAL

CLISTIN

DISC MCNEIL 4MG5ML N 008955 001 Apr 10 2000 Current OBYES

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December 2016 Page 10 of 50

TABLETORALCLISTIN

DISC ORTHO MCNEIL PHARM 4MG N 008915 001 May 21 1998 Current OBYES

CARBOPLATININJECTABLEINJECTIONPARAPLATIN

DISC CORDEN PHARMA 50MGVIAL N 019880 001 Dec 19 2008 Current OBYESDISC 150MGVIAL N 019880 002 Dec 19 2008 Current OBYESDISC 450MGVIAL N 019880 003 Dec 19 2008 Current OBYESINJECTABLEIV (INFUSION)PARAPLATIN

DISC CORDENPHARMA 50MG5ML (10MGML) N 020452 001 Jun 15 2012 Current OBYESDISC 150MG15ML (10MGML) N 020452 002 Jun 15 2012 Current OBYESDISC 450MG45ML (10MGML) N 020452 003 Jun 15 2012 Current OBYESDISC 600MG60ML (10MGML) N 020452 004 Jun 15 2012 Current OBYES

CEFACLORCAPSULEORALCECLOR

DISC LILLY EQ 250MG BASE N 050521 001 Oct 01 2008 Current OBYESDISC EQ 500MG BASE N 050521 002 Oct 01 2008 Current OBYESFOR SUSPENSIONORALCECLOR

DISC LILLY EQ 125MG BASE5ML N 050522 001 Oct 01 2008 Current OBYESDISC EQ 250MG BASE5ML N 050522 002 Oct 01 2008 Current OBYES

CEFADROXILCEFADROXIL HEMIHYDRATECAPSULEORALDURICEF

DISC WARNER CHILCOTT EQ 500MG BASE N 050512 001 Mar 26 2007 Current OBYESFOR SUSPENSIONORALDURICEF

DISC WARNER CHILCOTT EQ 125MG BASE5ML N 050527 002 Mar 02 2011 Current OBYESDISC EQ 250MG BASE5ML N 050527 003 Mar 02 2011 Current OBYESDISC EQ 500MG BASE5ML N 050527 001 Mar 02 2011 Current OBYESTABLETORALDURICEF

DISC WARNER CHILCOTT EQ 1GM BASE N 050528 001 Mar 26 2007 Current OBYES

CEFAZOLIN SODIUMINJECTABLEINJECTIONANCEF

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL N 050461 003 Oct 30 2015 Current OBYESDISC EQ 5GM BASEVIAL N 050461 004 Mar 07 2008 Current OBYESDISC EQ 10GM BASEVIAL N 050461 005 Oct 30 2015 Current OBYESDISC EQ 250MG BASEVIAL N 050461 001 Mar 07 2008 Current OBYESDISC EQ 500MG BASEVIAL N 050461 002 Mar 07 2008 Current OBNO

CEFAZOLIN SODIUMDISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 064169 002 Oct 30 2015 Current OBYESDISC EQ 500MG BASEVIAL A 064169 001 Oct 30 2015 Current OBYES

CEFDINIRCAPSULEORALOMNICEF

DISC ABBVIE 300MG N 050739 001 Nov 18 2016 Current OBYESFOR SUSPENSIONORALOMNICEF

DISC ABBVIE 125MG5ML N 050749 001 Nov 18 2016 Current OBYESDISC 250MG5ML N 050749 002 Nov 18 2016 Current OBYES

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December 2016 Page 11 of 50

CEFIXIMEFOR SUSPENSIONORALSUPRAX

DISC LEDERLE 100MG5ML N 050622 001 Feb 18 2004 Current OBYESTABLETORALSUPRAX

DISC LEDERLE 200MG N 050621 001 Feb 18 2004 Current OBYESDISC 400MG N 050621 002 Feb 18 2004 Current OBYES

CEFMETAZOLE SODIUMINJECTABLEINJECTIONZEFAZONE

DISC PHARMACIA AND EQ 1GM BASEVIAL N 050637 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 2GM BASEVIAL N 050637 002 Mar 10 2014 Current OBYESZEFAZONE IN PLASTIC CONTAINER

DISC PHARMACIA AND EQ 20MG BASEML N 050683 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 40MG BASEML N 050683 002 Mar 10 2014 Current OBYES

CEFOTETAN DISODIUMINJECTABLEINJECTIONCEFOTAN

RX TELIGENT PHARMA EQ 1GM BASEVIAL N 050588 001 Jun 07 2007 Current OBNOINC

RX EQ 2GM BASEVIAL N 050588 002 Jun 07 2007 Current OBNO

CEFOXITIN SODIUMINJECTABLEINJECTIONCEFOXITIN

DISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 065012 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 065012 002 May 04 2016 Current OBYES

MEFOXINDISC MYLAN EQ 1GM BASEVIAL N 050517 001 Mar 11 2010 Current OBYES

INSTITUTIONALDISC EQ 2GM BASEVIAL N 050517 002 Mar 11 2010 Current OBYESDISC EQ 10GM BASEVIAL N 050517 003 Sep 06 2007 Current OBYES

CEFPODOXIME PROXETILFOR SUSPENSIONORALVANTIN

DISC PHARMACIA AND EQ 50MG BASE5ML N 050675 001 Jan 21 2016 Current OBYESUPJOHN

DISC EQ 100MG BASE5ML N 050675 002 Jan 21 2016 Current OBYES

CEFTRIAXONE SODIUMINJECTABLEINJECTIONROCEPHIN

DISC HOFFMANN LA ROCHE EQ 10GM BASEVIAL N 050585 005 Mar 15 2011 Current OBNOROCEPHIN W DEXTROSE IN PLASTIC CONTAINER

DISC HOFFMANN LA ROCHE EQ 10MG BASEML N 050624 001 Nov 18 2016 Current OBYESDISC EQ 20MG BASEML N 050624 002 Nov 18 2016 Current OBYESDISC EQ 40MG BASEML N 050624 003 Nov 18 2016 Current OBYESINJECTABLEINTRAMUSCULAR INTRAVENOUSROCEPHIN

DISC HOFFMANN LA ROCHE EQ 1GM BASEVIAL N 050585 003 Mar 15 2011 Current OBNODISC EQ 2GM BASEVIAL N 050585 004 Mar 15 2011 Current OBNODISC EQ 250MG BASEVIAL N 050585 001 Mar 15 2011 Current OBNODISC EQ 500MG BASEVIAL N 050585 002 Mar 15 2011 Current OBNO

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December 2016 Page 12 of 50

CEPHALEXINCAPSULEORALKEFLEX

DISC PRAGMA PHARMS LLC EQ 333MG BASE N 050405 004 Apr 12 2011 Current OBYESFOR SUSPENSIONORALCEPHALEXIN

DISC FACTA FARMA EQ 100MG BASEML A 062117 001 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML A 062117 002 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML A 062117 003 Mar 15 2016 Current OBYES

KEFLEXDISC PRAGMA PHARMS LLC EQ 100MG BASEML N 050406 003 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML N 050406 001 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML N 050406 002 Mar 15 2016 Current OBYES

CHENODIOLTABLETORALCHENIX

DISC SIGMA TAU 250MG N 018513 002 May 23 2007 Current OBYES

CHLOROTHIAZIDESUSPENSIONORALDIURIL

RX SALIX PHARMS 250MG5ML N 011870 001 May 23 2007 Current OBNOTABLETORALDIURIL

DISC OAK PHARMS AKORN 250MG N 011145 004 May 23 2007 Current OBYESDISC 500MG N 011145 002 May 23 2007 Current OBYES

CHLORPROMAZINESUPPOSITORYRECTALTHORAZINE

DISC GLAXOSMITHKLINE 25MG N 009149 024 Jun 15 2009 Current OBYESDISC 100MG N 009149 033 Jun 15 2009 Current OBYES

CHLORPROMAZINE HYDROCHLORIDECONCENTRATEORALTHORAZINE

DISC GLAXOSMITHKLINE 30MGML N 009149 032 Jun 15 2009 Current OBYESDISC 100MGML N 009149 043 Jun 15 2009 Current OBYESINJECTABLEINJECTIONTHORAZINE

DISC GLAXOSMITHKLINE 25MGML N 009149 011 Jun 15 2009 Current OBYESSYRUPORALTHORAZINE

DISC GLAXOSMITHKLINE 10MG5ML N 009149 022 Jun 15 2009 Current OBYESTABLETORALCHLORPROMAZINE HYDROCHLORIDE

DISC SANDOZ 10MG A 080439 001 Jan 21 2016 Current OBYESDISC 25MG A 080439 002 Jan 21 2016 Current OBYESDISC 50MG A 080439 003 Jan 21 2016 Current OBYESDISC 100MG A 080439 004 Jan 21 2016 Current OBYESDISC 200MG A 080439 005 Jan 21 2016 Current OBYES

THORAZINEDISC GLAXOSMITHKLINE 10MG N 009149 002 May 23 2007 Current OBYESDISC 25MG N 009149 007 May 23 2007 Current OBYESDISC 50MG N 009149 013 May 23 2007 Current OBYESDISC 100MG N 009149 018 May 23 2007 Current OBYESDISC 200MG N 009149 020 May 23 2007 Current OBYES

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December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

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December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

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December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

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December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

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DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

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DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

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December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

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December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 4: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 4 of 50

FOR SUSPENSIONORALAUGMENTIN ES-600

RX DR REDDYS LABS INC 600MG5MLEQ 429MG BASE5ML N 050755 001 Dec 07 2010 Current OBNOTABLET CHEWABLEORALAUGMENTIN 125

DISC DR REDDYS LABS INC 125MGEQ 3125MG BASE N 050597 001 Dec 07 2010 Current OBYESAUGMENTIN 200

RX DR REDDYS LABS INC 200MGEQ 285MG BASE N 050726 001 Dec 07 2010 Current OBNOAUGMENTIN 250

DISC DR REDDYS LABS INC 250MGEQ 625MG BASE N 050597 002 Dec 07 2010 Current OBYESAUGMENTIN 400

RX DR REDDYS LABS INC 400MGEQ 57MG BASE N 050726 002 Dec 07 2010 Current OBNO

AMPHETAMINE ADIPATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE ADIPATE DEXTROAMPHETAMINE SULFATECAPSULEORALDELCOBESE

DISC TEVA 125MG125MG125MG125MG A 083564 001 Nov 10 2003 Current OBYES

DISC 25MG25MG25MG25MG A 083564 002 Nov 10 2003 Current OBYES

DISC 375MG375MG375MG375MG A 083564 003 Nov 10 2003 Current OBYES

DISC 5MG5MG5MG5MG A 083564 004 Nov 10 2003 Current OBYES

TABLETORAL

DELCOBESE

DISC TEVA 125MG125MG125MG125MG A 083563 004 Nov 10 2003 Current OBNO

DISC 25MG25MG25MG25MG A 083563 003 Nov 10 2003 Current OBNO

DISC 375MG375MG375MG375MG A 083563 002 Nov 10 2003 Current OBNO

DISC 5MG5MG5MG5MG A 083563 001 Nov 10 2003 Current OBNO

AMPHETAMINE ASPARTATE AMPHETAMINE SULFATE DEXTROAMPHETAMINE SACCHARATE DEXTROAMPHETAMINESULFATETABLETORALADDERALL 10

DISC TEVA WOMENS 25MG25MG25MG25MG N 011522 007 Nov 12 2013 Current OBYESADDERALL 125

DISC TEVA WOMENS 3125MG3125MG3125MG3125MG N 011522 012 Nov 12 2013 Current OBYESADDERALL 15

DISC TEVA WOMENS 375MG375MG375MG375MG N 011522 013 Nov 12 2013 Current OBYESADDERALL 20

DISC TEVA WOMENS 5MG5MG5MG5MG N 011522 008 Nov 12 2013 Current OBYESADDERALL 30

DISC TEVA WOMENS 75MG75MG75MG75MG N 011522 010 Nov 12 2013 Current OBYESADDERALL 5

DISC TEVA WOMENS 125MG125MG125MG125MG N 011522 009 Nov 12 2013 Current OBYESADDERALL 75

DISC TEVA WOMENS 1875MG1875MG1875MG1875MG N 011522 011 Nov 12 2013 Current OBYES

AMPHETAMINE SULFATETABLETORALAMPHETAMINE SULFATE

DISC LANNETT 5MG A 083901 001 Nov 10 2010 Current OBNODISC 10MG A 083901 002 Nov 10 2010 Current OBNO

AMPRENAVIRSOLUTIONORALAGENERASE

DISC GLAXOSMITHKLINE 15MGML N 021039 001 Jul 22 2011 Current OBYES

ANAGRELIDE HYDROCHLORIDECAPSULEORALAGRYLIN

DISC SHIRE LLC EQ 1MG BASE N 020333 002 Oct 01 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 5 of 50

ARDEPARIN SODIUMINJECTABLEINJECTIONNORMIFLO

DISC PHARMACIA AND 5000 UNITS05ML N 020227 002 May 23 2002 Current OBYESUPJOHN

DISC 10000 UNITS05ML N 020227 001 May 23 2002 Current OBYES

ARIPIPRAZOLESOLUTIONORALABILIFY

DISC OTSUKA 1MGML N 021713 001 Jun 23 2015 Current OBYESTABLET ORALLY DISINTEGRATINGORALABILIFY

DISC OTSUKA 20MG N 021729 004 Dec 03 2009 Current OBYESDISC 30MG N 021729 005 Dec 03 2009 Current OBYES

ARMODAFINILTABLETORALNUVIGIL

DISC CEPHALON 100MG N 021875 002 Jul 22 2011 Current OBYESRX 200MG N 021875 005 Jul 22 2011 Current OBNO

ASPIRIN BUTALBITAL CAFFEINETABLETORALFIORINAL

DISC ALLERGAN SALES LLC 325MG50MG40MG N 017534 003 Nov 18 2016 Current OBYES

ASPIRIN CAFFEINE ORPHENADRINE CITRATETABLETORALNORGESIC

DISC MEDICIS 385MG30MG25MG N 013416 003 Oct 30 2015 Current OBYESNORGESIC FORTE

DISC MEDICIS 770MG60MG50MG N 013416 004 Oct 30 2015 Current OBYES

ASPIRIN HYDROCODONE BITARTRATETABLETORALAZDONE

DISC SCHWARZ PHARMA 500MG5MG A 089420 001 Oct 05 2010 Current OBYES

ASPIRIN PENTAZOCINE HYDROCHLORIDETABLETORALTALWIN COMPOUND

DISC SANOFI AVENTIS US 325MGEQ 125MG BASE N 016891 001 Aug 30 2011 Current OBYES

ATAZANAVIR SULFATECAPSULEORALREYATAZ

DISC BRISTOL MYERS EQ 100MG BASE N 021567 001 Jan 06 2015 Current OBYESSQUIBB

ATENOLOLINJECTABLEINJECTIONTENORMIN

DISC ASTRAZENECA 05MGML N 019058 001 Dec 19 2008 Current OBYES

ATORVASTATIN CALCIUM EZETIMIBETABLETORALLIPTRUZET

DISC MERCK SHARP DOHME EQ 10MG BASE10MG N 200153 001 Nov 20 2015 Current OBYESDISC EQ 20MG BASE10MG N 200153 002 Nov 20 2015 Current OBYESDISC EQ 40MG BASE10MG N 200153 003 Nov 20 2015 Current OBYESDISC EQ 80MG BASE10MG N 200153 004 Nov 20 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 6 of 50

ATOVAQUONETABLETORALMEPRON

DISC GLAXOSMITHKLINE 250MG N 020259 001 May 16 2007 Current OBYESLLC

ATRACURIUM BESYLATEINJECTABLEINJECTIONTRACRIUM

DISC HOSPIRA 10MGML N 018831 002 May 14 2009 Current OBYESTRACRIUM PRESERVATIVE FREE

DISC HOSPIRA 10MGML N 018831 001 May 14 2009 Current OBYES

AZATHIOPRINETABLETORALIMURAN

DISC SEBELA IRELAND LTD 25MG N 016324 002 Feb 20 2002 Current OBYES

AZATHIOPRINE SODIUMINJECTABLEINJECTIONIMURAN

DISC SEBELA IRELAND LTD EQ 100MG BASEVIAL N 017391 001 May 23 2007 Current OBYES

AZITHROMYCINCAPSULEORALZITHROMAX

DISC PFIZER EQ 250MG BASE N 050670 001 May 20 2005 Current OBYES

BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATEOINTMENTOPHTHALMICCORTISPORIN

DISC CASPER PHARMA LLC 400 UNITSGM1EQ 35MG N 050416 002 Mar 07 2008 Current OBYESBASEGM10000 UNITSGM

BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEOINTMENTOPHTHALMICNEOSPORIN

DISC CASPER PHARMA LLC 400 UNITSGMEQ 35MG N 050417 001 Oct 01 2008 Current OBYESBASEGM10000 UNITSGM

BACITRACIN ZINC POLYMYXIN B SULFATEOINTMENTOPHTHALMICPOLYSPORIN

DISC MONARCH PHARMS 500 UNITSGM10000 UNITSGM A 061229 001 Oct 01 2008 Current OBYES

BACLOFENTABLETORALLIORESAL

DISC NOVARTIS 10MG N 017851 001 Aug 06 2003 Current OBYESDISC 20MG N 017851 003 Aug 06 2003 Current OBYES

BENZONATATECAPSULEORALTESSALON

DISC PFIZER 200MG N 011210 003 Jul 20 2015 Current OBYES

BENZPHETAMINE HYDROCHLORIDETABLETORALDIDREX

DISC PHARMACIA AND 25MG N 012427 003 Mar 25 2010 Current OBYESUPJOHN

DISC 50MG N 012427 002 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 7 of 50

BENZTROPINE MESYLATETABLETORALBENZTROPINE MESYLATE

DISC LANNETT HOLDINGS

INC

05MG A 088877 001 Nov 18 2016 Current OBYES

DISC 1MG A 088894 001 Nov 18 2016 Current OBYES

DISC 2MG A 088895 001 Nov 18 2016 Current OBYES

COGENTIN

DISC

DISC

DISC

MERCK 05MG

1MG

2MG

N 009193 004 Aug 06 2003 Current OBYES

N 009193 003 Aug 06 2003 Current OBYES

N 009193 002 Aug 06 2003 Current OBYES

BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE SOLUSPAN

RX MERCK SHARP DOHME 3MGMLEQ 3MG BASEML N 014602 001 Jan 12 2006 Current OBNO

BETAMETHASONE DIPROPIONATELOTIONTOPICALDIPROSONE

DISC SCHERING EQ 005 BASE N 017781 001 Nov 18 2016 Current OBYES

BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE

DISC SCHERING EQ 3MG BASEML N 017561 001 Jan 12 2006 Current OBYES

BETHANECHOL CHLORIDEINJECTABLEINJECTIONURECHOLINE

DISC ODYSSEY PHARMS 5MGML N 006536 001 Feb 21 2001 Current OBYESTABLETORALURECHOLINE

DISC ODYSSEY PHARMS 5MG N 006536 003 Feb 21 2001 Current OBYESDISC 10MG N 006536 002 Feb 21 2001 Current OBYESDISC 25MG N 006536 004 Feb 21 2001 Current OBYESDISC 50MG N 006536 005 Feb 21 2001 Current OBYES

BIMATOPROSTSOLUTIONDROPSOPHTHALMICLUMIGAN

DISC ALLERGAN 003 N 021275 001 Oct 31 2014 Current OBYES

BISACODYL POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDEFOR SOLUTION TABLET DELAYED RELEASEORALHALFLYTELY

DISC BRAINTREE 5MGNANA210GMNA074GMN N 021551 003 Jul 20 2015 Current OBYESA286GMNA56GM

BISMUTH SUBSALICYLATE METRONIDAZOLE TETRACYCLINE HYDROCHLORIDETABLET CHEWABLE TABLET CAPSULEORALHELIDAC

DISC SEBELA IRELAND LTD 2624MGNANANA250MGNAN N 050719 001 Jul 20 2015 Current OBYESANA500MG

BLEOMYCIN SULFATEINJECTABLEINJECTIONBLENOXANE

DISC BRISTOL MYERS EQ 15 UNITS BASEVIAL N 050443 001 Jan 21 2016 Current OBYESSQUIBB

DISC EQ 30 UNITS BASEVIAL N 050443 002 Jan 21 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 8 of 50

BRETYLIUM TOSYLATEINJECTABLEINJECTIONBRETYLIUM TOSYLATE

DISC HOSPIRA 50MGML N 019030 001 Dec 19 2011 Current OBYES

BRIMONIDINE TARTRATESOLUTIONDROPSOPHTHALMICALPHAGAN

DISC ALLERGAN 02 N 020613 001 Jun 11 2003 Current OBYES

BROMFENAC SODIUMSOLUTIONDROPSOPHTHALMICBROMDAY

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 002 Dec 04 2015 Current OBYESINCXIBROM

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 001 May 13 2011 Current OBYESINC

BROMOCRIPTINE MESYLATECAPSULEORALPARLODEL

RX US PHARMS HOLDINGS EQ 5MG BASE N 017962 002 Sep 06 2016 Current OBYESI

BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDESYRUPORALDIMETANE-DX

DISC ROBINS AH 2MG5ML10MG5ML30MG5ML N 019279 001 May 04 2016 Current OBYES

BUMETANIDEINJECTABLEINJECTIONBUMEX

DISC VALIDUS PHARMS INC 025MGML N 018226 001 Sep 06 2007 Current OBYESTABLETORALBUMEX

RX VALIDUS PHARMS INC 05MG N 018225 002 Oct 30 2015 Current OBYESRX 1MG N 018225 001 Oct 30 2015 Current OBYESRX 2MG N 018225 003 Oct 30 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDETABLETSUBLINGUALSUBUTEX

DISC INDIVIOR INC EQ 2MG BASE N 020732 002 Feb 13 2015 Current OBYESDISC EQ 8MG BASE N 020732 003 Feb 13 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDETABLETSUBLINGUALSUBOXONE

DISC INDIVIOR INC EQ 2MG BASEEQ 05MG BASE N 020733 001 Jun 06 2013 Current OBYESDISC EQ 8MG BASEEQ 2MG BASE N 020733 002 Jun 06 2013 Current OBNO

BUSPIRONE HYDROCHLORIDETABLETORALBUSPAR

DISC

DISC

BRISTOL MYERS

SQUIBB

5MG

10MG

N 018731 001 Sep 06 2016 Current OBYES

N 018731 002 Oct 19 2010 Current OBYES

DISC 15MG N 018731 003 Oct 19 2010 Current OBYES

DISC 30MG N 018731 004 Oct 19 2010 Current OBYES

BUSPIRONE HYDROCHLORIDE

DISC IVAX SUB TEVA

PHARMS

5MG A 075385 001 Sep 06 2016 Current OBYES

DISC

DISC

10MG

15MG

A 075385 002 Sep 06 2016 Current OBYES

A 075385 003 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 9 of 50

CABERGOLINE

TABLETORAL

DOSTINEX

DISC PHARMACIA AND

UPJOHN

05MG N 020664 001 Mar 11 2010 Current OBYES

CAFFEINE ERGOTAMINE TARTRATE

SUPPOSITORYRECTAL

CAFERGOT

DISC NOVARTIS 100MG2MG N 009000 002 Apr 28 2008 Current OBYES

CALCIPOTRIENE

OINTMENTTOPICAL

DOVONEX

LEO PHARMA ASDISC

SOLUTIONTOPICAL

DOVONEX

0005 N 020273 001 Mar 09 2010 Current OBYES

LEO PHARMDISC 0005 N 020611 001 Oct 31 2014 Current OBYES

CALCIUM ACETATE

TABLETORAL

PHOSLO

DISC FRESENIUS MEDCL 667MG N 019976 001 Aug 06 2007 Current OBYES

CALCIUM CARBONATE RISEDRONATE SODIUM

TABLET TABLETORAL

ACTONEL WITH CALCIUM (COPACKAGED)

WARNER CHILCOTT EQ 500MG BASENANA35MGDISC N 021823 001 Jul 07 2010 Current OBYES

CAPTOPRIL

TABLETORAL

CAPOTEN

DISC

DISC

DISC

DISC

DISC

DISC

DISC

PAR PHARM 125MG

25MG

375MG

50MG

75MG

100MG

150MG

N 018343 005 Oct 30 2015 Current OBYES

N 018343 002 Oct 30 2015 Current OBYES

N 018343 006 Jan 21 2016 Current OBYES

N 018343 001 Oct 30 2015 Current OBYES

N 018343 007 Jan 21 2016 Current OBYES

N 018343 003 Oct 30 2015 Current OBYES

N 018343 004 Jan 21 2016 Current OBYES

CAPTOPRIL HYDROCHLOROTHIAZIDE

TABLETORAL

CAPOZIDE 2515

APOTHECON 25MG15MGDISC

CAPOZIDE 2525

APOTHECON 25MG25MGDISC

CAPOZIDE 5015

APOTHECON 50MG15MGDISC

CAPOZIDE 5025

APOTHECON 50MG25MGDISC

N 018709 001 Jan 09 2015 Current OBYES

N 018709 002 Jan 09 2015 Current OBYES

N 018709 004 Jan 09 2015 Current OBYES

N 018709 003 Jan 09 2015 Current OBYES

CARBIDOPA LEVODOPA

TABLET ORALLY DISINTEGRATINGORAL

PARCOPA

DISC

DISC

DISC

UCB INC 10MG100MG

25MG100MG

25MG250MG

A 076699 001 Jan 09 2015 Current OBYES

A 076699 002 Jan 09 2015 Current OBYES

A 076699 003 Jan 09 2015 Current OBYES

CARBINOXAMINE MALEATE

ELIXIRORAL

CLISTIN

DISC MCNEIL 4MG5ML N 008955 001 Apr 10 2000 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 10 of 50

TABLETORALCLISTIN

DISC ORTHO MCNEIL PHARM 4MG N 008915 001 May 21 1998 Current OBYES

CARBOPLATININJECTABLEINJECTIONPARAPLATIN

DISC CORDEN PHARMA 50MGVIAL N 019880 001 Dec 19 2008 Current OBYESDISC 150MGVIAL N 019880 002 Dec 19 2008 Current OBYESDISC 450MGVIAL N 019880 003 Dec 19 2008 Current OBYESINJECTABLEIV (INFUSION)PARAPLATIN

DISC CORDENPHARMA 50MG5ML (10MGML) N 020452 001 Jun 15 2012 Current OBYESDISC 150MG15ML (10MGML) N 020452 002 Jun 15 2012 Current OBYESDISC 450MG45ML (10MGML) N 020452 003 Jun 15 2012 Current OBYESDISC 600MG60ML (10MGML) N 020452 004 Jun 15 2012 Current OBYES

CEFACLORCAPSULEORALCECLOR

DISC LILLY EQ 250MG BASE N 050521 001 Oct 01 2008 Current OBYESDISC EQ 500MG BASE N 050521 002 Oct 01 2008 Current OBYESFOR SUSPENSIONORALCECLOR

DISC LILLY EQ 125MG BASE5ML N 050522 001 Oct 01 2008 Current OBYESDISC EQ 250MG BASE5ML N 050522 002 Oct 01 2008 Current OBYES

CEFADROXILCEFADROXIL HEMIHYDRATECAPSULEORALDURICEF

DISC WARNER CHILCOTT EQ 500MG BASE N 050512 001 Mar 26 2007 Current OBYESFOR SUSPENSIONORALDURICEF

DISC WARNER CHILCOTT EQ 125MG BASE5ML N 050527 002 Mar 02 2011 Current OBYESDISC EQ 250MG BASE5ML N 050527 003 Mar 02 2011 Current OBYESDISC EQ 500MG BASE5ML N 050527 001 Mar 02 2011 Current OBYESTABLETORALDURICEF

DISC WARNER CHILCOTT EQ 1GM BASE N 050528 001 Mar 26 2007 Current OBYES

CEFAZOLIN SODIUMINJECTABLEINJECTIONANCEF

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL N 050461 003 Oct 30 2015 Current OBYESDISC EQ 5GM BASEVIAL N 050461 004 Mar 07 2008 Current OBYESDISC EQ 10GM BASEVIAL N 050461 005 Oct 30 2015 Current OBYESDISC EQ 250MG BASEVIAL N 050461 001 Mar 07 2008 Current OBYESDISC EQ 500MG BASEVIAL N 050461 002 Mar 07 2008 Current OBNO

CEFAZOLIN SODIUMDISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 064169 002 Oct 30 2015 Current OBYESDISC EQ 500MG BASEVIAL A 064169 001 Oct 30 2015 Current OBYES

CEFDINIRCAPSULEORALOMNICEF

DISC ABBVIE 300MG N 050739 001 Nov 18 2016 Current OBYESFOR SUSPENSIONORALOMNICEF

DISC ABBVIE 125MG5ML N 050749 001 Nov 18 2016 Current OBYESDISC 250MG5ML N 050749 002 Nov 18 2016 Current OBYES

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December 2016 Page 11 of 50

CEFIXIMEFOR SUSPENSIONORALSUPRAX

DISC LEDERLE 100MG5ML N 050622 001 Feb 18 2004 Current OBYESTABLETORALSUPRAX

DISC LEDERLE 200MG N 050621 001 Feb 18 2004 Current OBYESDISC 400MG N 050621 002 Feb 18 2004 Current OBYES

CEFMETAZOLE SODIUMINJECTABLEINJECTIONZEFAZONE

DISC PHARMACIA AND EQ 1GM BASEVIAL N 050637 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 2GM BASEVIAL N 050637 002 Mar 10 2014 Current OBYESZEFAZONE IN PLASTIC CONTAINER

DISC PHARMACIA AND EQ 20MG BASEML N 050683 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 40MG BASEML N 050683 002 Mar 10 2014 Current OBYES

CEFOTETAN DISODIUMINJECTABLEINJECTIONCEFOTAN

RX TELIGENT PHARMA EQ 1GM BASEVIAL N 050588 001 Jun 07 2007 Current OBNOINC

RX EQ 2GM BASEVIAL N 050588 002 Jun 07 2007 Current OBNO

CEFOXITIN SODIUMINJECTABLEINJECTIONCEFOXITIN

DISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 065012 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 065012 002 May 04 2016 Current OBYES

MEFOXINDISC MYLAN EQ 1GM BASEVIAL N 050517 001 Mar 11 2010 Current OBYES

INSTITUTIONALDISC EQ 2GM BASEVIAL N 050517 002 Mar 11 2010 Current OBYESDISC EQ 10GM BASEVIAL N 050517 003 Sep 06 2007 Current OBYES

CEFPODOXIME PROXETILFOR SUSPENSIONORALVANTIN

DISC PHARMACIA AND EQ 50MG BASE5ML N 050675 001 Jan 21 2016 Current OBYESUPJOHN

DISC EQ 100MG BASE5ML N 050675 002 Jan 21 2016 Current OBYES

CEFTRIAXONE SODIUMINJECTABLEINJECTIONROCEPHIN

DISC HOFFMANN LA ROCHE EQ 10GM BASEVIAL N 050585 005 Mar 15 2011 Current OBNOROCEPHIN W DEXTROSE IN PLASTIC CONTAINER

DISC HOFFMANN LA ROCHE EQ 10MG BASEML N 050624 001 Nov 18 2016 Current OBYESDISC EQ 20MG BASEML N 050624 002 Nov 18 2016 Current OBYESDISC EQ 40MG BASEML N 050624 003 Nov 18 2016 Current OBYESINJECTABLEINTRAMUSCULAR INTRAVENOUSROCEPHIN

DISC HOFFMANN LA ROCHE EQ 1GM BASEVIAL N 050585 003 Mar 15 2011 Current OBNODISC EQ 2GM BASEVIAL N 050585 004 Mar 15 2011 Current OBNODISC EQ 250MG BASEVIAL N 050585 001 Mar 15 2011 Current OBNODISC EQ 500MG BASEVIAL N 050585 002 Mar 15 2011 Current OBNO

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December 2016 Page 12 of 50

CEPHALEXINCAPSULEORALKEFLEX

DISC PRAGMA PHARMS LLC EQ 333MG BASE N 050405 004 Apr 12 2011 Current OBYESFOR SUSPENSIONORALCEPHALEXIN

DISC FACTA FARMA EQ 100MG BASEML A 062117 001 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML A 062117 002 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML A 062117 003 Mar 15 2016 Current OBYES

KEFLEXDISC PRAGMA PHARMS LLC EQ 100MG BASEML N 050406 003 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML N 050406 001 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML N 050406 002 Mar 15 2016 Current OBYES

CHENODIOLTABLETORALCHENIX

DISC SIGMA TAU 250MG N 018513 002 May 23 2007 Current OBYES

CHLOROTHIAZIDESUSPENSIONORALDIURIL

RX SALIX PHARMS 250MG5ML N 011870 001 May 23 2007 Current OBNOTABLETORALDIURIL

DISC OAK PHARMS AKORN 250MG N 011145 004 May 23 2007 Current OBYESDISC 500MG N 011145 002 May 23 2007 Current OBYES

CHLORPROMAZINESUPPOSITORYRECTALTHORAZINE

DISC GLAXOSMITHKLINE 25MG N 009149 024 Jun 15 2009 Current OBYESDISC 100MG N 009149 033 Jun 15 2009 Current OBYES

CHLORPROMAZINE HYDROCHLORIDECONCENTRATEORALTHORAZINE

DISC GLAXOSMITHKLINE 30MGML N 009149 032 Jun 15 2009 Current OBYESDISC 100MGML N 009149 043 Jun 15 2009 Current OBYESINJECTABLEINJECTIONTHORAZINE

DISC GLAXOSMITHKLINE 25MGML N 009149 011 Jun 15 2009 Current OBYESSYRUPORALTHORAZINE

DISC GLAXOSMITHKLINE 10MG5ML N 009149 022 Jun 15 2009 Current OBYESTABLETORALCHLORPROMAZINE HYDROCHLORIDE

DISC SANDOZ 10MG A 080439 001 Jan 21 2016 Current OBYESDISC 25MG A 080439 002 Jan 21 2016 Current OBYESDISC 50MG A 080439 003 Jan 21 2016 Current OBYESDISC 100MG A 080439 004 Jan 21 2016 Current OBYESDISC 200MG A 080439 005 Jan 21 2016 Current OBYES

THORAZINEDISC GLAXOSMITHKLINE 10MG N 009149 002 May 23 2007 Current OBYESDISC 25MG N 009149 007 May 23 2007 Current OBYESDISC 50MG N 009149 013 May 23 2007 Current OBYESDISC 100MG N 009149 018 May 23 2007 Current OBYESDISC 200MG N 009149 020 May 23 2007 Current OBYES

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December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

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December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

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December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

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December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

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DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

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December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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December 2016 Page 21 of 50

TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 5: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 5 of 50

ARDEPARIN SODIUMINJECTABLEINJECTIONNORMIFLO

DISC PHARMACIA AND 5000 UNITS05ML N 020227 002 May 23 2002 Current OBYESUPJOHN

DISC 10000 UNITS05ML N 020227 001 May 23 2002 Current OBYES

ARIPIPRAZOLESOLUTIONORALABILIFY

DISC OTSUKA 1MGML N 021713 001 Jun 23 2015 Current OBYESTABLET ORALLY DISINTEGRATINGORALABILIFY

DISC OTSUKA 20MG N 021729 004 Dec 03 2009 Current OBYESDISC 30MG N 021729 005 Dec 03 2009 Current OBYES

ARMODAFINILTABLETORALNUVIGIL

DISC CEPHALON 100MG N 021875 002 Jul 22 2011 Current OBYESRX 200MG N 021875 005 Jul 22 2011 Current OBNO

ASPIRIN BUTALBITAL CAFFEINETABLETORALFIORINAL

DISC ALLERGAN SALES LLC 325MG50MG40MG N 017534 003 Nov 18 2016 Current OBYES

ASPIRIN CAFFEINE ORPHENADRINE CITRATETABLETORALNORGESIC

DISC MEDICIS 385MG30MG25MG N 013416 003 Oct 30 2015 Current OBYESNORGESIC FORTE

DISC MEDICIS 770MG60MG50MG N 013416 004 Oct 30 2015 Current OBYES

ASPIRIN HYDROCODONE BITARTRATETABLETORALAZDONE

DISC SCHWARZ PHARMA 500MG5MG A 089420 001 Oct 05 2010 Current OBYES

ASPIRIN PENTAZOCINE HYDROCHLORIDETABLETORALTALWIN COMPOUND

DISC SANOFI AVENTIS US 325MGEQ 125MG BASE N 016891 001 Aug 30 2011 Current OBYES

ATAZANAVIR SULFATECAPSULEORALREYATAZ

DISC BRISTOL MYERS EQ 100MG BASE N 021567 001 Jan 06 2015 Current OBYESSQUIBB

ATENOLOLINJECTABLEINJECTIONTENORMIN

DISC ASTRAZENECA 05MGML N 019058 001 Dec 19 2008 Current OBYES

ATORVASTATIN CALCIUM EZETIMIBETABLETORALLIPTRUZET

DISC MERCK SHARP DOHME EQ 10MG BASE10MG N 200153 001 Nov 20 2015 Current OBYESDISC EQ 20MG BASE10MG N 200153 002 Nov 20 2015 Current OBYESDISC EQ 40MG BASE10MG N 200153 003 Nov 20 2015 Current OBYESDISC EQ 80MG BASE10MG N 200153 004 Nov 20 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 6 of 50

ATOVAQUONETABLETORALMEPRON

DISC GLAXOSMITHKLINE 250MG N 020259 001 May 16 2007 Current OBYESLLC

ATRACURIUM BESYLATEINJECTABLEINJECTIONTRACRIUM

DISC HOSPIRA 10MGML N 018831 002 May 14 2009 Current OBYESTRACRIUM PRESERVATIVE FREE

DISC HOSPIRA 10MGML N 018831 001 May 14 2009 Current OBYES

AZATHIOPRINETABLETORALIMURAN

DISC SEBELA IRELAND LTD 25MG N 016324 002 Feb 20 2002 Current OBYES

AZATHIOPRINE SODIUMINJECTABLEINJECTIONIMURAN

DISC SEBELA IRELAND LTD EQ 100MG BASEVIAL N 017391 001 May 23 2007 Current OBYES

AZITHROMYCINCAPSULEORALZITHROMAX

DISC PFIZER EQ 250MG BASE N 050670 001 May 20 2005 Current OBYES

BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATEOINTMENTOPHTHALMICCORTISPORIN

DISC CASPER PHARMA LLC 400 UNITSGM1EQ 35MG N 050416 002 Mar 07 2008 Current OBYESBASEGM10000 UNITSGM

BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEOINTMENTOPHTHALMICNEOSPORIN

DISC CASPER PHARMA LLC 400 UNITSGMEQ 35MG N 050417 001 Oct 01 2008 Current OBYESBASEGM10000 UNITSGM

BACITRACIN ZINC POLYMYXIN B SULFATEOINTMENTOPHTHALMICPOLYSPORIN

DISC MONARCH PHARMS 500 UNITSGM10000 UNITSGM A 061229 001 Oct 01 2008 Current OBYES

BACLOFENTABLETORALLIORESAL

DISC NOVARTIS 10MG N 017851 001 Aug 06 2003 Current OBYESDISC 20MG N 017851 003 Aug 06 2003 Current OBYES

BENZONATATECAPSULEORALTESSALON

DISC PFIZER 200MG N 011210 003 Jul 20 2015 Current OBYES

BENZPHETAMINE HYDROCHLORIDETABLETORALDIDREX

DISC PHARMACIA AND 25MG N 012427 003 Mar 25 2010 Current OBYESUPJOHN

DISC 50MG N 012427 002 Dec 04 2015 Current OBYES

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December 2016 Page 7 of 50

BENZTROPINE MESYLATETABLETORALBENZTROPINE MESYLATE

DISC LANNETT HOLDINGS

INC

05MG A 088877 001 Nov 18 2016 Current OBYES

DISC 1MG A 088894 001 Nov 18 2016 Current OBYES

DISC 2MG A 088895 001 Nov 18 2016 Current OBYES

COGENTIN

DISC

DISC

DISC

MERCK 05MG

1MG

2MG

N 009193 004 Aug 06 2003 Current OBYES

N 009193 003 Aug 06 2003 Current OBYES

N 009193 002 Aug 06 2003 Current OBYES

BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE SOLUSPAN

RX MERCK SHARP DOHME 3MGMLEQ 3MG BASEML N 014602 001 Jan 12 2006 Current OBNO

BETAMETHASONE DIPROPIONATELOTIONTOPICALDIPROSONE

DISC SCHERING EQ 005 BASE N 017781 001 Nov 18 2016 Current OBYES

BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE

DISC SCHERING EQ 3MG BASEML N 017561 001 Jan 12 2006 Current OBYES

BETHANECHOL CHLORIDEINJECTABLEINJECTIONURECHOLINE

DISC ODYSSEY PHARMS 5MGML N 006536 001 Feb 21 2001 Current OBYESTABLETORALURECHOLINE

DISC ODYSSEY PHARMS 5MG N 006536 003 Feb 21 2001 Current OBYESDISC 10MG N 006536 002 Feb 21 2001 Current OBYESDISC 25MG N 006536 004 Feb 21 2001 Current OBYESDISC 50MG N 006536 005 Feb 21 2001 Current OBYES

BIMATOPROSTSOLUTIONDROPSOPHTHALMICLUMIGAN

DISC ALLERGAN 003 N 021275 001 Oct 31 2014 Current OBYES

BISACODYL POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDEFOR SOLUTION TABLET DELAYED RELEASEORALHALFLYTELY

DISC BRAINTREE 5MGNANA210GMNA074GMN N 021551 003 Jul 20 2015 Current OBYESA286GMNA56GM

BISMUTH SUBSALICYLATE METRONIDAZOLE TETRACYCLINE HYDROCHLORIDETABLET CHEWABLE TABLET CAPSULEORALHELIDAC

DISC SEBELA IRELAND LTD 2624MGNANANA250MGNAN N 050719 001 Jul 20 2015 Current OBYESANA500MG

BLEOMYCIN SULFATEINJECTABLEINJECTIONBLENOXANE

DISC BRISTOL MYERS EQ 15 UNITS BASEVIAL N 050443 001 Jan 21 2016 Current OBYESSQUIBB

DISC EQ 30 UNITS BASEVIAL N 050443 002 Jan 21 2016 Current OBYES

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December 2016 Page 8 of 50

BRETYLIUM TOSYLATEINJECTABLEINJECTIONBRETYLIUM TOSYLATE

DISC HOSPIRA 50MGML N 019030 001 Dec 19 2011 Current OBYES

BRIMONIDINE TARTRATESOLUTIONDROPSOPHTHALMICALPHAGAN

DISC ALLERGAN 02 N 020613 001 Jun 11 2003 Current OBYES

BROMFENAC SODIUMSOLUTIONDROPSOPHTHALMICBROMDAY

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 002 Dec 04 2015 Current OBYESINCXIBROM

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 001 May 13 2011 Current OBYESINC

BROMOCRIPTINE MESYLATECAPSULEORALPARLODEL

RX US PHARMS HOLDINGS EQ 5MG BASE N 017962 002 Sep 06 2016 Current OBYESI

BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDESYRUPORALDIMETANE-DX

DISC ROBINS AH 2MG5ML10MG5ML30MG5ML N 019279 001 May 04 2016 Current OBYES

BUMETANIDEINJECTABLEINJECTIONBUMEX

DISC VALIDUS PHARMS INC 025MGML N 018226 001 Sep 06 2007 Current OBYESTABLETORALBUMEX

RX VALIDUS PHARMS INC 05MG N 018225 002 Oct 30 2015 Current OBYESRX 1MG N 018225 001 Oct 30 2015 Current OBYESRX 2MG N 018225 003 Oct 30 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDETABLETSUBLINGUALSUBUTEX

DISC INDIVIOR INC EQ 2MG BASE N 020732 002 Feb 13 2015 Current OBYESDISC EQ 8MG BASE N 020732 003 Feb 13 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDETABLETSUBLINGUALSUBOXONE

DISC INDIVIOR INC EQ 2MG BASEEQ 05MG BASE N 020733 001 Jun 06 2013 Current OBYESDISC EQ 8MG BASEEQ 2MG BASE N 020733 002 Jun 06 2013 Current OBNO

BUSPIRONE HYDROCHLORIDETABLETORALBUSPAR

DISC

DISC

BRISTOL MYERS

SQUIBB

5MG

10MG

N 018731 001 Sep 06 2016 Current OBYES

N 018731 002 Oct 19 2010 Current OBYES

DISC 15MG N 018731 003 Oct 19 2010 Current OBYES

DISC 30MG N 018731 004 Oct 19 2010 Current OBYES

BUSPIRONE HYDROCHLORIDE

DISC IVAX SUB TEVA

PHARMS

5MG A 075385 001 Sep 06 2016 Current OBYES

DISC

DISC

10MG

15MG

A 075385 002 Sep 06 2016 Current OBYES

A 075385 003 Sep 06 2016 Current OBYES

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December 2016 Page 9 of 50

CABERGOLINE

TABLETORAL

DOSTINEX

DISC PHARMACIA AND

UPJOHN

05MG N 020664 001 Mar 11 2010 Current OBYES

CAFFEINE ERGOTAMINE TARTRATE

SUPPOSITORYRECTAL

CAFERGOT

DISC NOVARTIS 100MG2MG N 009000 002 Apr 28 2008 Current OBYES

CALCIPOTRIENE

OINTMENTTOPICAL

DOVONEX

LEO PHARMA ASDISC

SOLUTIONTOPICAL

DOVONEX

0005 N 020273 001 Mar 09 2010 Current OBYES

LEO PHARMDISC 0005 N 020611 001 Oct 31 2014 Current OBYES

CALCIUM ACETATE

TABLETORAL

PHOSLO

DISC FRESENIUS MEDCL 667MG N 019976 001 Aug 06 2007 Current OBYES

CALCIUM CARBONATE RISEDRONATE SODIUM

TABLET TABLETORAL

ACTONEL WITH CALCIUM (COPACKAGED)

WARNER CHILCOTT EQ 500MG BASENANA35MGDISC N 021823 001 Jul 07 2010 Current OBYES

CAPTOPRIL

TABLETORAL

CAPOTEN

DISC

DISC

DISC

DISC

DISC

DISC

DISC

PAR PHARM 125MG

25MG

375MG

50MG

75MG

100MG

150MG

N 018343 005 Oct 30 2015 Current OBYES

N 018343 002 Oct 30 2015 Current OBYES

N 018343 006 Jan 21 2016 Current OBYES

N 018343 001 Oct 30 2015 Current OBYES

N 018343 007 Jan 21 2016 Current OBYES

N 018343 003 Oct 30 2015 Current OBYES

N 018343 004 Jan 21 2016 Current OBYES

CAPTOPRIL HYDROCHLOROTHIAZIDE

TABLETORAL

CAPOZIDE 2515

APOTHECON 25MG15MGDISC

CAPOZIDE 2525

APOTHECON 25MG25MGDISC

CAPOZIDE 5015

APOTHECON 50MG15MGDISC

CAPOZIDE 5025

APOTHECON 50MG25MGDISC

N 018709 001 Jan 09 2015 Current OBYES

N 018709 002 Jan 09 2015 Current OBYES

N 018709 004 Jan 09 2015 Current OBYES

N 018709 003 Jan 09 2015 Current OBYES

CARBIDOPA LEVODOPA

TABLET ORALLY DISINTEGRATINGORAL

PARCOPA

DISC

DISC

DISC

UCB INC 10MG100MG

25MG100MG

25MG250MG

A 076699 001 Jan 09 2015 Current OBYES

A 076699 002 Jan 09 2015 Current OBYES

A 076699 003 Jan 09 2015 Current OBYES

CARBINOXAMINE MALEATE

ELIXIRORAL

CLISTIN

DISC MCNEIL 4MG5ML N 008955 001 Apr 10 2000 Current OBYES

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December 2016 Page 10 of 50

TABLETORALCLISTIN

DISC ORTHO MCNEIL PHARM 4MG N 008915 001 May 21 1998 Current OBYES

CARBOPLATININJECTABLEINJECTIONPARAPLATIN

DISC CORDEN PHARMA 50MGVIAL N 019880 001 Dec 19 2008 Current OBYESDISC 150MGVIAL N 019880 002 Dec 19 2008 Current OBYESDISC 450MGVIAL N 019880 003 Dec 19 2008 Current OBYESINJECTABLEIV (INFUSION)PARAPLATIN

DISC CORDENPHARMA 50MG5ML (10MGML) N 020452 001 Jun 15 2012 Current OBYESDISC 150MG15ML (10MGML) N 020452 002 Jun 15 2012 Current OBYESDISC 450MG45ML (10MGML) N 020452 003 Jun 15 2012 Current OBYESDISC 600MG60ML (10MGML) N 020452 004 Jun 15 2012 Current OBYES

CEFACLORCAPSULEORALCECLOR

DISC LILLY EQ 250MG BASE N 050521 001 Oct 01 2008 Current OBYESDISC EQ 500MG BASE N 050521 002 Oct 01 2008 Current OBYESFOR SUSPENSIONORALCECLOR

DISC LILLY EQ 125MG BASE5ML N 050522 001 Oct 01 2008 Current OBYESDISC EQ 250MG BASE5ML N 050522 002 Oct 01 2008 Current OBYES

CEFADROXILCEFADROXIL HEMIHYDRATECAPSULEORALDURICEF

DISC WARNER CHILCOTT EQ 500MG BASE N 050512 001 Mar 26 2007 Current OBYESFOR SUSPENSIONORALDURICEF

DISC WARNER CHILCOTT EQ 125MG BASE5ML N 050527 002 Mar 02 2011 Current OBYESDISC EQ 250MG BASE5ML N 050527 003 Mar 02 2011 Current OBYESDISC EQ 500MG BASE5ML N 050527 001 Mar 02 2011 Current OBYESTABLETORALDURICEF

DISC WARNER CHILCOTT EQ 1GM BASE N 050528 001 Mar 26 2007 Current OBYES

CEFAZOLIN SODIUMINJECTABLEINJECTIONANCEF

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL N 050461 003 Oct 30 2015 Current OBYESDISC EQ 5GM BASEVIAL N 050461 004 Mar 07 2008 Current OBYESDISC EQ 10GM BASEVIAL N 050461 005 Oct 30 2015 Current OBYESDISC EQ 250MG BASEVIAL N 050461 001 Mar 07 2008 Current OBYESDISC EQ 500MG BASEVIAL N 050461 002 Mar 07 2008 Current OBNO

CEFAZOLIN SODIUMDISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 064169 002 Oct 30 2015 Current OBYESDISC EQ 500MG BASEVIAL A 064169 001 Oct 30 2015 Current OBYES

CEFDINIRCAPSULEORALOMNICEF

DISC ABBVIE 300MG N 050739 001 Nov 18 2016 Current OBYESFOR SUSPENSIONORALOMNICEF

DISC ABBVIE 125MG5ML N 050749 001 Nov 18 2016 Current OBYESDISC 250MG5ML N 050749 002 Nov 18 2016 Current OBYES

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December 2016 Page 11 of 50

CEFIXIMEFOR SUSPENSIONORALSUPRAX

DISC LEDERLE 100MG5ML N 050622 001 Feb 18 2004 Current OBYESTABLETORALSUPRAX

DISC LEDERLE 200MG N 050621 001 Feb 18 2004 Current OBYESDISC 400MG N 050621 002 Feb 18 2004 Current OBYES

CEFMETAZOLE SODIUMINJECTABLEINJECTIONZEFAZONE

DISC PHARMACIA AND EQ 1GM BASEVIAL N 050637 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 2GM BASEVIAL N 050637 002 Mar 10 2014 Current OBYESZEFAZONE IN PLASTIC CONTAINER

DISC PHARMACIA AND EQ 20MG BASEML N 050683 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 40MG BASEML N 050683 002 Mar 10 2014 Current OBYES

CEFOTETAN DISODIUMINJECTABLEINJECTIONCEFOTAN

RX TELIGENT PHARMA EQ 1GM BASEVIAL N 050588 001 Jun 07 2007 Current OBNOINC

RX EQ 2GM BASEVIAL N 050588 002 Jun 07 2007 Current OBNO

CEFOXITIN SODIUMINJECTABLEINJECTIONCEFOXITIN

DISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 065012 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 065012 002 May 04 2016 Current OBYES

MEFOXINDISC MYLAN EQ 1GM BASEVIAL N 050517 001 Mar 11 2010 Current OBYES

INSTITUTIONALDISC EQ 2GM BASEVIAL N 050517 002 Mar 11 2010 Current OBYESDISC EQ 10GM BASEVIAL N 050517 003 Sep 06 2007 Current OBYES

CEFPODOXIME PROXETILFOR SUSPENSIONORALVANTIN

DISC PHARMACIA AND EQ 50MG BASE5ML N 050675 001 Jan 21 2016 Current OBYESUPJOHN

DISC EQ 100MG BASE5ML N 050675 002 Jan 21 2016 Current OBYES

CEFTRIAXONE SODIUMINJECTABLEINJECTIONROCEPHIN

DISC HOFFMANN LA ROCHE EQ 10GM BASEVIAL N 050585 005 Mar 15 2011 Current OBNOROCEPHIN W DEXTROSE IN PLASTIC CONTAINER

DISC HOFFMANN LA ROCHE EQ 10MG BASEML N 050624 001 Nov 18 2016 Current OBYESDISC EQ 20MG BASEML N 050624 002 Nov 18 2016 Current OBYESDISC EQ 40MG BASEML N 050624 003 Nov 18 2016 Current OBYESINJECTABLEINTRAMUSCULAR INTRAVENOUSROCEPHIN

DISC HOFFMANN LA ROCHE EQ 1GM BASEVIAL N 050585 003 Mar 15 2011 Current OBNODISC EQ 2GM BASEVIAL N 050585 004 Mar 15 2011 Current OBNODISC EQ 250MG BASEVIAL N 050585 001 Mar 15 2011 Current OBNODISC EQ 500MG BASEVIAL N 050585 002 Mar 15 2011 Current OBNO

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December 2016 Page 12 of 50

CEPHALEXINCAPSULEORALKEFLEX

DISC PRAGMA PHARMS LLC EQ 333MG BASE N 050405 004 Apr 12 2011 Current OBYESFOR SUSPENSIONORALCEPHALEXIN

DISC FACTA FARMA EQ 100MG BASEML A 062117 001 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML A 062117 002 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML A 062117 003 Mar 15 2016 Current OBYES

KEFLEXDISC PRAGMA PHARMS LLC EQ 100MG BASEML N 050406 003 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML N 050406 001 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML N 050406 002 Mar 15 2016 Current OBYES

CHENODIOLTABLETORALCHENIX

DISC SIGMA TAU 250MG N 018513 002 May 23 2007 Current OBYES

CHLOROTHIAZIDESUSPENSIONORALDIURIL

RX SALIX PHARMS 250MG5ML N 011870 001 May 23 2007 Current OBNOTABLETORALDIURIL

DISC OAK PHARMS AKORN 250MG N 011145 004 May 23 2007 Current OBYESDISC 500MG N 011145 002 May 23 2007 Current OBYES

CHLORPROMAZINESUPPOSITORYRECTALTHORAZINE

DISC GLAXOSMITHKLINE 25MG N 009149 024 Jun 15 2009 Current OBYESDISC 100MG N 009149 033 Jun 15 2009 Current OBYES

CHLORPROMAZINE HYDROCHLORIDECONCENTRATEORALTHORAZINE

DISC GLAXOSMITHKLINE 30MGML N 009149 032 Jun 15 2009 Current OBYESDISC 100MGML N 009149 043 Jun 15 2009 Current OBYESINJECTABLEINJECTIONTHORAZINE

DISC GLAXOSMITHKLINE 25MGML N 009149 011 Jun 15 2009 Current OBYESSYRUPORALTHORAZINE

DISC GLAXOSMITHKLINE 10MG5ML N 009149 022 Jun 15 2009 Current OBYESTABLETORALCHLORPROMAZINE HYDROCHLORIDE

DISC SANDOZ 10MG A 080439 001 Jan 21 2016 Current OBYESDISC 25MG A 080439 002 Jan 21 2016 Current OBYESDISC 50MG A 080439 003 Jan 21 2016 Current OBYESDISC 100MG A 080439 004 Jan 21 2016 Current OBYESDISC 200MG A 080439 005 Jan 21 2016 Current OBYES

THORAZINEDISC GLAXOSMITHKLINE 10MG N 009149 002 May 23 2007 Current OBYESDISC 25MG N 009149 007 May 23 2007 Current OBYESDISC 50MG N 009149 013 May 23 2007 Current OBYESDISC 100MG N 009149 018 May 23 2007 Current OBYESDISC 200MG N 009149 020 May 23 2007 Current OBYES

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December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

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December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

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December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

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December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

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DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

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DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

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2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

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See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 6: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 6 of 50

ATOVAQUONETABLETORALMEPRON

DISC GLAXOSMITHKLINE 250MG N 020259 001 May 16 2007 Current OBYESLLC

ATRACURIUM BESYLATEINJECTABLEINJECTIONTRACRIUM

DISC HOSPIRA 10MGML N 018831 002 May 14 2009 Current OBYESTRACRIUM PRESERVATIVE FREE

DISC HOSPIRA 10MGML N 018831 001 May 14 2009 Current OBYES

AZATHIOPRINETABLETORALIMURAN

DISC SEBELA IRELAND LTD 25MG N 016324 002 Feb 20 2002 Current OBYES

AZATHIOPRINE SODIUMINJECTABLEINJECTIONIMURAN

DISC SEBELA IRELAND LTD EQ 100MG BASEVIAL N 017391 001 May 23 2007 Current OBYES

AZITHROMYCINCAPSULEORALZITHROMAX

DISC PFIZER EQ 250MG BASE N 050670 001 May 20 2005 Current OBYES

BACITRACIN ZINC HYDROCORTISONE NEOMYCIN SULFATE POLYMYXIN B SULFATEOINTMENTOPHTHALMICCORTISPORIN

DISC CASPER PHARMA LLC 400 UNITSGM1EQ 35MG N 050416 002 Mar 07 2008 Current OBYESBASEGM10000 UNITSGM

BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEOINTMENTOPHTHALMICNEOSPORIN

DISC CASPER PHARMA LLC 400 UNITSGMEQ 35MG N 050417 001 Oct 01 2008 Current OBYESBASEGM10000 UNITSGM

BACITRACIN ZINC POLYMYXIN B SULFATEOINTMENTOPHTHALMICPOLYSPORIN

DISC MONARCH PHARMS 500 UNITSGM10000 UNITSGM A 061229 001 Oct 01 2008 Current OBYES

BACLOFENTABLETORALLIORESAL

DISC NOVARTIS 10MG N 017851 001 Aug 06 2003 Current OBYESDISC 20MG N 017851 003 Aug 06 2003 Current OBYES

BENZONATATECAPSULEORALTESSALON

DISC PFIZER 200MG N 011210 003 Jul 20 2015 Current OBYES

BENZPHETAMINE HYDROCHLORIDETABLETORALDIDREX

DISC PHARMACIA AND 25MG N 012427 003 Mar 25 2010 Current OBYESUPJOHN

DISC 50MG N 012427 002 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 7 of 50

BENZTROPINE MESYLATETABLETORALBENZTROPINE MESYLATE

DISC LANNETT HOLDINGS

INC

05MG A 088877 001 Nov 18 2016 Current OBYES

DISC 1MG A 088894 001 Nov 18 2016 Current OBYES

DISC 2MG A 088895 001 Nov 18 2016 Current OBYES

COGENTIN

DISC

DISC

DISC

MERCK 05MG

1MG

2MG

N 009193 004 Aug 06 2003 Current OBYES

N 009193 003 Aug 06 2003 Current OBYES

N 009193 002 Aug 06 2003 Current OBYES

BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE SOLUSPAN

RX MERCK SHARP DOHME 3MGMLEQ 3MG BASEML N 014602 001 Jan 12 2006 Current OBNO

BETAMETHASONE DIPROPIONATELOTIONTOPICALDIPROSONE

DISC SCHERING EQ 005 BASE N 017781 001 Nov 18 2016 Current OBYES

BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE

DISC SCHERING EQ 3MG BASEML N 017561 001 Jan 12 2006 Current OBYES

BETHANECHOL CHLORIDEINJECTABLEINJECTIONURECHOLINE

DISC ODYSSEY PHARMS 5MGML N 006536 001 Feb 21 2001 Current OBYESTABLETORALURECHOLINE

DISC ODYSSEY PHARMS 5MG N 006536 003 Feb 21 2001 Current OBYESDISC 10MG N 006536 002 Feb 21 2001 Current OBYESDISC 25MG N 006536 004 Feb 21 2001 Current OBYESDISC 50MG N 006536 005 Feb 21 2001 Current OBYES

BIMATOPROSTSOLUTIONDROPSOPHTHALMICLUMIGAN

DISC ALLERGAN 003 N 021275 001 Oct 31 2014 Current OBYES

BISACODYL POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDEFOR SOLUTION TABLET DELAYED RELEASEORALHALFLYTELY

DISC BRAINTREE 5MGNANA210GMNA074GMN N 021551 003 Jul 20 2015 Current OBYESA286GMNA56GM

BISMUTH SUBSALICYLATE METRONIDAZOLE TETRACYCLINE HYDROCHLORIDETABLET CHEWABLE TABLET CAPSULEORALHELIDAC

DISC SEBELA IRELAND LTD 2624MGNANANA250MGNAN N 050719 001 Jul 20 2015 Current OBYESANA500MG

BLEOMYCIN SULFATEINJECTABLEINJECTIONBLENOXANE

DISC BRISTOL MYERS EQ 15 UNITS BASEVIAL N 050443 001 Jan 21 2016 Current OBYESSQUIBB

DISC EQ 30 UNITS BASEVIAL N 050443 002 Jan 21 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 8 of 50

BRETYLIUM TOSYLATEINJECTABLEINJECTIONBRETYLIUM TOSYLATE

DISC HOSPIRA 50MGML N 019030 001 Dec 19 2011 Current OBYES

BRIMONIDINE TARTRATESOLUTIONDROPSOPHTHALMICALPHAGAN

DISC ALLERGAN 02 N 020613 001 Jun 11 2003 Current OBYES

BROMFENAC SODIUMSOLUTIONDROPSOPHTHALMICBROMDAY

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 002 Dec 04 2015 Current OBYESINCXIBROM

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 001 May 13 2011 Current OBYESINC

BROMOCRIPTINE MESYLATECAPSULEORALPARLODEL

RX US PHARMS HOLDINGS EQ 5MG BASE N 017962 002 Sep 06 2016 Current OBYESI

BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDESYRUPORALDIMETANE-DX

DISC ROBINS AH 2MG5ML10MG5ML30MG5ML N 019279 001 May 04 2016 Current OBYES

BUMETANIDEINJECTABLEINJECTIONBUMEX

DISC VALIDUS PHARMS INC 025MGML N 018226 001 Sep 06 2007 Current OBYESTABLETORALBUMEX

RX VALIDUS PHARMS INC 05MG N 018225 002 Oct 30 2015 Current OBYESRX 1MG N 018225 001 Oct 30 2015 Current OBYESRX 2MG N 018225 003 Oct 30 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDETABLETSUBLINGUALSUBUTEX

DISC INDIVIOR INC EQ 2MG BASE N 020732 002 Feb 13 2015 Current OBYESDISC EQ 8MG BASE N 020732 003 Feb 13 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDETABLETSUBLINGUALSUBOXONE

DISC INDIVIOR INC EQ 2MG BASEEQ 05MG BASE N 020733 001 Jun 06 2013 Current OBYESDISC EQ 8MG BASEEQ 2MG BASE N 020733 002 Jun 06 2013 Current OBNO

BUSPIRONE HYDROCHLORIDETABLETORALBUSPAR

DISC

DISC

BRISTOL MYERS

SQUIBB

5MG

10MG

N 018731 001 Sep 06 2016 Current OBYES

N 018731 002 Oct 19 2010 Current OBYES

DISC 15MG N 018731 003 Oct 19 2010 Current OBYES

DISC 30MG N 018731 004 Oct 19 2010 Current OBYES

BUSPIRONE HYDROCHLORIDE

DISC IVAX SUB TEVA

PHARMS

5MG A 075385 001 Sep 06 2016 Current OBYES

DISC

DISC

10MG

15MG

A 075385 002 Sep 06 2016 Current OBYES

A 075385 003 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 9 of 50

CABERGOLINE

TABLETORAL

DOSTINEX

DISC PHARMACIA AND

UPJOHN

05MG N 020664 001 Mar 11 2010 Current OBYES

CAFFEINE ERGOTAMINE TARTRATE

SUPPOSITORYRECTAL

CAFERGOT

DISC NOVARTIS 100MG2MG N 009000 002 Apr 28 2008 Current OBYES

CALCIPOTRIENE

OINTMENTTOPICAL

DOVONEX

LEO PHARMA ASDISC

SOLUTIONTOPICAL

DOVONEX

0005 N 020273 001 Mar 09 2010 Current OBYES

LEO PHARMDISC 0005 N 020611 001 Oct 31 2014 Current OBYES

CALCIUM ACETATE

TABLETORAL

PHOSLO

DISC FRESENIUS MEDCL 667MG N 019976 001 Aug 06 2007 Current OBYES

CALCIUM CARBONATE RISEDRONATE SODIUM

TABLET TABLETORAL

ACTONEL WITH CALCIUM (COPACKAGED)

WARNER CHILCOTT EQ 500MG BASENANA35MGDISC N 021823 001 Jul 07 2010 Current OBYES

CAPTOPRIL

TABLETORAL

CAPOTEN

DISC

DISC

DISC

DISC

DISC

DISC

DISC

PAR PHARM 125MG

25MG

375MG

50MG

75MG

100MG

150MG

N 018343 005 Oct 30 2015 Current OBYES

N 018343 002 Oct 30 2015 Current OBYES

N 018343 006 Jan 21 2016 Current OBYES

N 018343 001 Oct 30 2015 Current OBYES

N 018343 007 Jan 21 2016 Current OBYES

N 018343 003 Oct 30 2015 Current OBYES

N 018343 004 Jan 21 2016 Current OBYES

CAPTOPRIL HYDROCHLOROTHIAZIDE

TABLETORAL

CAPOZIDE 2515

APOTHECON 25MG15MGDISC

CAPOZIDE 2525

APOTHECON 25MG25MGDISC

CAPOZIDE 5015

APOTHECON 50MG15MGDISC

CAPOZIDE 5025

APOTHECON 50MG25MGDISC

N 018709 001 Jan 09 2015 Current OBYES

N 018709 002 Jan 09 2015 Current OBYES

N 018709 004 Jan 09 2015 Current OBYES

N 018709 003 Jan 09 2015 Current OBYES

CARBIDOPA LEVODOPA

TABLET ORALLY DISINTEGRATINGORAL

PARCOPA

DISC

DISC

DISC

UCB INC 10MG100MG

25MG100MG

25MG250MG

A 076699 001 Jan 09 2015 Current OBYES

A 076699 002 Jan 09 2015 Current OBYES

A 076699 003 Jan 09 2015 Current OBYES

CARBINOXAMINE MALEATE

ELIXIRORAL

CLISTIN

DISC MCNEIL 4MG5ML N 008955 001 Apr 10 2000 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 10 of 50

TABLETORALCLISTIN

DISC ORTHO MCNEIL PHARM 4MG N 008915 001 May 21 1998 Current OBYES

CARBOPLATININJECTABLEINJECTIONPARAPLATIN

DISC CORDEN PHARMA 50MGVIAL N 019880 001 Dec 19 2008 Current OBYESDISC 150MGVIAL N 019880 002 Dec 19 2008 Current OBYESDISC 450MGVIAL N 019880 003 Dec 19 2008 Current OBYESINJECTABLEIV (INFUSION)PARAPLATIN

DISC CORDENPHARMA 50MG5ML (10MGML) N 020452 001 Jun 15 2012 Current OBYESDISC 150MG15ML (10MGML) N 020452 002 Jun 15 2012 Current OBYESDISC 450MG45ML (10MGML) N 020452 003 Jun 15 2012 Current OBYESDISC 600MG60ML (10MGML) N 020452 004 Jun 15 2012 Current OBYES

CEFACLORCAPSULEORALCECLOR

DISC LILLY EQ 250MG BASE N 050521 001 Oct 01 2008 Current OBYESDISC EQ 500MG BASE N 050521 002 Oct 01 2008 Current OBYESFOR SUSPENSIONORALCECLOR

DISC LILLY EQ 125MG BASE5ML N 050522 001 Oct 01 2008 Current OBYESDISC EQ 250MG BASE5ML N 050522 002 Oct 01 2008 Current OBYES

CEFADROXILCEFADROXIL HEMIHYDRATECAPSULEORALDURICEF

DISC WARNER CHILCOTT EQ 500MG BASE N 050512 001 Mar 26 2007 Current OBYESFOR SUSPENSIONORALDURICEF

DISC WARNER CHILCOTT EQ 125MG BASE5ML N 050527 002 Mar 02 2011 Current OBYESDISC EQ 250MG BASE5ML N 050527 003 Mar 02 2011 Current OBYESDISC EQ 500MG BASE5ML N 050527 001 Mar 02 2011 Current OBYESTABLETORALDURICEF

DISC WARNER CHILCOTT EQ 1GM BASE N 050528 001 Mar 26 2007 Current OBYES

CEFAZOLIN SODIUMINJECTABLEINJECTIONANCEF

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL N 050461 003 Oct 30 2015 Current OBYESDISC EQ 5GM BASEVIAL N 050461 004 Mar 07 2008 Current OBYESDISC EQ 10GM BASEVIAL N 050461 005 Oct 30 2015 Current OBYESDISC EQ 250MG BASEVIAL N 050461 001 Mar 07 2008 Current OBYESDISC EQ 500MG BASEVIAL N 050461 002 Mar 07 2008 Current OBNO

CEFAZOLIN SODIUMDISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 064169 002 Oct 30 2015 Current OBYESDISC EQ 500MG BASEVIAL A 064169 001 Oct 30 2015 Current OBYES

CEFDINIRCAPSULEORALOMNICEF

DISC ABBVIE 300MG N 050739 001 Nov 18 2016 Current OBYESFOR SUSPENSIONORALOMNICEF

DISC ABBVIE 125MG5ML N 050749 001 Nov 18 2016 Current OBYESDISC 250MG5ML N 050749 002 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 11 of 50

CEFIXIMEFOR SUSPENSIONORALSUPRAX

DISC LEDERLE 100MG5ML N 050622 001 Feb 18 2004 Current OBYESTABLETORALSUPRAX

DISC LEDERLE 200MG N 050621 001 Feb 18 2004 Current OBYESDISC 400MG N 050621 002 Feb 18 2004 Current OBYES

CEFMETAZOLE SODIUMINJECTABLEINJECTIONZEFAZONE

DISC PHARMACIA AND EQ 1GM BASEVIAL N 050637 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 2GM BASEVIAL N 050637 002 Mar 10 2014 Current OBYESZEFAZONE IN PLASTIC CONTAINER

DISC PHARMACIA AND EQ 20MG BASEML N 050683 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 40MG BASEML N 050683 002 Mar 10 2014 Current OBYES

CEFOTETAN DISODIUMINJECTABLEINJECTIONCEFOTAN

RX TELIGENT PHARMA EQ 1GM BASEVIAL N 050588 001 Jun 07 2007 Current OBNOINC

RX EQ 2GM BASEVIAL N 050588 002 Jun 07 2007 Current OBNO

CEFOXITIN SODIUMINJECTABLEINJECTIONCEFOXITIN

DISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 065012 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 065012 002 May 04 2016 Current OBYES

MEFOXINDISC MYLAN EQ 1GM BASEVIAL N 050517 001 Mar 11 2010 Current OBYES

INSTITUTIONALDISC EQ 2GM BASEVIAL N 050517 002 Mar 11 2010 Current OBYESDISC EQ 10GM BASEVIAL N 050517 003 Sep 06 2007 Current OBYES

CEFPODOXIME PROXETILFOR SUSPENSIONORALVANTIN

DISC PHARMACIA AND EQ 50MG BASE5ML N 050675 001 Jan 21 2016 Current OBYESUPJOHN

DISC EQ 100MG BASE5ML N 050675 002 Jan 21 2016 Current OBYES

CEFTRIAXONE SODIUMINJECTABLEINJECTIONROCEPHIN

DISC HOFFMANN LA ROCHE EQ 10GM BASEVIAL N 050585 005 Mar 15 2011 Current OBNOROCEPHIN W DEXTROSE IN PLASTIC CONTAINER

DISC HOFFMANN LA ROCHE EQ 10MG BASEML N 050624 001 Nov 18 2016 Current OBYESDISC EQ 20MG BASEML N 050624 002 Nov 18 2016 Current OBYESDISC EQ 40MG BASEML N 050624 003 Nov 18 2016 Current OBYESINJECTABLEINTRAMUSCULAR INTRAVENOUSROCEPHIN

DISC HOFFMANN LA ROCHE EQ 1GM BASEVIAL N 050585 003 Mar 15 2011 Current OBNODISC EQ 2GM BASEVIAL N 050585 004 Mar 15 2011 Current OBNODISC EQ 250MG BASEVIAL N 050585 001 Mar 15 2011 Current OBNODISC EQ 500MG BASEVIAL N 050585 002 Mar 15 2011 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 12 of 50

CEPHALEXINCAPSULEORALKEFLEX

DISC PRAGMA PHARMS LLC EQ 333MG BASE N 050405 004 Apr 12 2011 Current OBYESFOR SUSPENSIONORALCEPHALEXIN

DISC FACTA FARMA EQ 100MG BASEML A 062117 001 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML A 062117 002 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML A 062117 003 Mar 15 2016 Current OBYES

KEFLEXDISC PRAGMA PHARMS LLC EQ 100MG BASEML N 050406 003 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML N 050406 001 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML N 050406 002 Mar 15 2016 Current OBYES

CHENODIOLTABLETORALCHENIX

DISC SIGMA TAU 250MG N 018513 002 May 23 2007 Current OBYES

CHLOROTHIAZIDESUSPENSIONORALDIURIL

RX SALIX PHARMS 250MG5ML N 011870 001 May 23 2007 Current OBNOTABLETORALDIURIL

DISC OAK PHARMS AKORN 250MG N 011145 004 May 23 2007 Current OBYESDISC 500MG N 011145 002 May 23 2007 Current OBYES

CHLORPROMAZINESUPPOSITORYRECTALTHORAZINE

DISC GLAXOSMITHKLINE 25MG N 009149 024 Jun 15 2009 Current OBYESDISC 100MG N 009149 033 Jun 15 2009 Current OBYES

CHLORPROMAZINE HYDROCHLORIDECONCENTRATEORALTHORAZINE

DISC GLAXOSMITHKLINE 30MGML N 009149 032 Jun 15 2009 Current OBYESDISC 100MGML N 009149 043 Jun 15 2009 Current OBYESINJECTABLEINJECTIONTHORAZINE

DISC GLAXOSMITHKLINE 25MGML N 009149 011 Jun 15 2009 Current OBYESSYRUPORALTHORAZINE

DISC GLAXOSMITHKLINE 10MG5ML N 009149 022 Jun 15 2009 Current OBYESTABLETORALCHLORPROMAZINE HYDROCHLORIDE

DISC SANDOZ 10MG A 080439 001 Jan 21 2016 Current OBYESDISC 25MG A 080439 002 Jan 21 2016 Current OBYESDISC 50MG A 080439 003 Jan 21 2016 Current OBYESDISC 100MG A 080439 004 Jan 21 2016 Current OBYESDISC 200MG A 080439 005 Jan 21 2016 Current OBYES

THORAZINEDISC GLAXOSMITHKLINE 10MG N 009149 002 May 23 2007 Current OBYESDISC 25MG N 009149 007 May 23 2007 Current OBYESDISC 50MG N 009149 013 May 23 2007 Current OBYESDISC 100MG N 009149 018 May 23 2007 Current OBYESDISC 200MG N 009149 020 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

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December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

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CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

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December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

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December 2016 Page 17 of 50

DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

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December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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See List Footnote

December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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See List Footnote

December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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See List Footnote

December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 7: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 7 of 50

BENZTROPINE MESYLATETABLETORALBENZTROPINE MESYLATE

DISC LANNETT HOLDINGS

INC

05MG A 088877 001 Nov 18 2016 Current OBYES

DISC 1MG A 088894 001 Nov 18 2016 Current OBYES

DISC 2MG A 088895 001 Nov 18 2016 Current OBYES

COGENTIN

DISC

DISC

DISC

MERCK 05MG

1MG

2MG

N 009193 004 Aug 06 2003 Current OBYES

N 009193 003 Aug 06 2003 Current OBYES

N 009193 002 Aug 06 2003 Current OBYES

BETAMETHASONE ACETATE BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE SOLUSPAN

RX MERCK SHARP DOHME 3MGMLEQ 3MG BASEML N 014602 001 Jan 12 2006 Current OBNO

BETAMETHASONE DIPROPIONATELOTIONTOPICALDIPROSONE

DISC SCHERING EQ 005 BASE N 017781 001 Nov 18 2016 Current OBYES

BETAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONCELESTONE

DISC SCHERING EQ 3MG BASEML N 017561 001 Jan 12 2006 Current OBYES

BETHANECHOL CHLORIDEINJECTABLEINJECTIONURECHOLINE

DISC ODYSSEY PHARMS 5MGML N 006536 001 Feb 21 2001 Current OBYESTABLETORALURECHOLINE

DISC ODYSSEY PHARMS 5MG N 006536 003 Feb 21 2001 Current OBYESDISC 10MG N 006536 002 Feb 21 2001 Current OBYESDISC 25MG N 006536 004 Feb 21 2001 Current OBYESDISC 50MG N 006536 005 Feb 21 2001 Current OBYES

BIMATOPROSTSOLUTIONDROPSOPHTHALMICLUMIGAN

DISC ALLERGAN 003 N 021275 001 Oct 31 2014 Current OBYES

BISACODYL POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE SODIUM BICARBONATE SODIUM CHLORIDEFOR SOLUTION TABLET DELAYED RELEASEORALHALFLYTELY

DISC BRAINTREE 5MGNANA210GMNA074GMN N 021551 003 Jul 20 2015 Current OBYESA286GMNA56GM

BISMUTH SUBSALICYLATE METRONIDAZOLE TETRACYCLINE HYDROCHLORIDETABLET CHEWABLE TABLET CAPSULEORALHELIDAC

DISC SEBELA IRELAND LTD 2624MGNANANA250MGNAN N 050719 001 Jul 20 2015 Current OBYESANA500MG

BLEOMYCIN SULFATEINJECTABLEINJECTIONBLENOXANE

DISC BRISTOL MYERS EQ 15 UNITS BASEVIAL N 050443 001 Jan 21 2016 Current OBYESSQUIBB

DISC EQ 30 UNITS BASEVIAL N 050443 002 Jan 21 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 8 of 50

BRETYLIUM TOSYLATEINJECTABLEINJECTIONBRETYLIUM TOSYLATE

DISC HOSPIRA 50MGML N 019030 001 Dec 19 2011 Current OBYES

BRIMONIDINE TARTRATESOLUTIONDROPSOPHTHALMICALPHAGAN

DISC ALLERGAN 02 N 020613 001 Jun 11 2003 Current OBYES

BROMFENAC SODIUMSOLUTIONDROPSOPHTHALMICBROMDAY

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 002 Dec 04 2015 Current OBYESINCXIBROM

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 001 May 13 2011 Current OBYESINC

BROMOCRIPTINE MESYLATECAPSULEORALPARLODEL

RX US PHARMS HOLDINGS EQ 5MG BASE N 017962 002 Sep 06 2016 Current OBYESI

BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDESYRUPORALDIMETANE-DX

DISC ROBINS AH 2MG5ML10MG5ML30MG5ML N 019279 001 May 04 2016 Current OBYES

BUMETANIDEINJECTABLEINJECTIONBUMEX

DISC VALIDUS PHARMS INC 025MGML N 018226 001 Sep 06 2007 Current OBYESTABLETORALBUMEX

RX VALIDUS PHARMS INC 05MG N 018225 002 Oct 30 2015 Current OBYESRX 1MG N 018225 001 Oct 30 2015 Current OBYESRX 2MG N 018225 003 Oct 30 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDETABLETSUBLINGUALSUBUTEX

DISC INDIVIOR INC EQ 2MG BASE N 020732 002 Feb 13 2015 Current OBYESDISC EQ 8MG BASE N 020732 003 Feb 13 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDETABLETSUBLINGUALSUBOXONE

DISC INDIVIOR INC EQ 2MG BASEEQ 05MG BASE N 020733 001 Jun 06 2013 Current OBYESDISC EQ 8MG BASEEQ 2MG BASE N 020733 002 Jun 06 2013 Current OBNO

BUSPIRONE HYDROCHLORIDETABLETORALBUSPAR

DISC

DISC

BRISTOL MYERS

SQUIBB

5MG

10MG

N 018731 001 Sep 06 2016 Current OBYES

N 018731 002 Oct 19 2010 Current OBYES

DISC 15MG N 018731 003 Oct 19 2010 Current OBYES

DISC 30MG N 018731 004 Oct 19 2010 Current OBYES

BUSPIRONE HYDROCHLORIDE

DISC IVAX SUB TEVA

PHARMS

5MG A 075385 001 Sep 06 2016 Current OBYES

DISC

DISC

10MG

15MG

A 075385 002 Sep 06 2016 Current OBYES

A 075385 003 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 9 of 50

CABERGOLINE

TABLETORAL

DOSTINEX

DISC PHARMACIA AND

UPJOHN

05MG N 020664 001 Mar 11 2010 Current OBYES

CAFFEINE ERGOTAMINE TARTRATE

SUPPOSITORYRECTAL

CAFERGOT

DISC NOVARTIS 100MG2MG N 009000 002 Apr 28 2008 Current OBYES

CALCIPOTRIENE

OINTMENTTOPICAL

DOVONEX

LEO PHARMA ASDISC

SOLUTIONTOPICAL

DOVONEX

0005 N 020273 001 Mar 09 2010 Current OBYES

LEO PHARMDISC 0005 N 020611 001 Oct 31 2014 Current OBYES

CALCIUM ACETATE

TABLETORAL

PHOSLO

DISC FRESENIUS MEDCL 667MG N 019976 001 Aug 06 2007 Current OBYES

CALCIUM CARBONATE RISEDRONATE SODIUM

TABLET TABLETORAL

ACTONEL WITH CALCIUM (COPACKAGED)

WARNER CHILCOTT EQ 500MG BASENANA35MGDISC N 021823 001 Jul 07 2010 Current OBYES

CAPTOPRIL

TABLETORAL

CAPOTEN

DISC

DISC

DISC

DISC

DISC

DISC

DISC

PAR PHARM 125MG

25MG

375MG

50MG

75MG

100MG

150MG

N 018343 005 Oct 30 2015 Current OBYES

N 018343 002 Oct 30 2015 Current OBYES

N 018343 006 Jan 21 2016 Current OBYES

N 018343 001 Oct 30 2015 Current OBYES

N 018343 007 Jan 21 2016 Current OBYES

N 018343 003 Oct 30 2015 Current OBYES

N 018343 004 Jan 21 2016 Current OBYES

CAPTOPRIL HYDROCHLOROTHIAZIDE

TABLETORAL

CAPOZIDE 2515

APOTHECON 25MG15MGDISC

CAPOZIDE 2525

APOTHECON 25MG25MGDISC

CAPOZIDE 5015

APOTHECON 50MG15MGDISC

CAPOZIDE 5025

APOTHECON 50MG25MGDISC

N 018709 001 Jan 09 2015 Current OBYES

N 018709 002 Jan 09 2015 Current OBYES

N 018709 004 Jan 09 2015 Current OBYES

N 018709 003 Jan 09 2015 Current OBYES

CARBIDOPA LEVODOPA

TABLET ORALLY DISINTEGRATINGORAL

PARCOPA

DISC

DISC

DISC

UCB INC 10MG100MG

25MG100MG

25MG250MG

A 076699 001 Jan 09 2015 Current OBYES

A 076699 002 Jan 09 2015 Current OBYES

A 076699 003 Jan 09 2015 Current OBYES

CARBINOXAMINE MALEATE

ELIXIRORAL

CLISTIN

DISC MCNEIL 4MG5ML N 008955 001 Apr 10 2000 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 10 of 50

TABLETORALCLISTIN

DISC ORTHO MCNEIL PHARM 4MG N 008915 001 May 21 1998 Current OBYES

CARBOPLATININJECTABLEINJECTIONPARAPLATIN

DISC CORDEN PHARMA 50MGVIAL N 019880 001 Dec 19 2008 Current OBYESDISC 150MGVIAL N 019880 002 Dec 19 2008 Current OBYESDISC 450MGVIAL N 019880 003 Dec 19 2008 Current OBYESINJECTABLEIV (INFUSION)PARAPLATIN

DISC CORDENPHARMA 50MG5ML (10MGML) N 020452 001 Jun 15 2012 Current OBYESDISC 150MG15ML (10MGML) N 020452 002 Jun 15 2012 Current OBYESDISC 450MG45ML (10MGML) N 020452 003 Jun 15 2012 Current OBYESDISC 600MG60ML (10MGML) N 020452 004 Jun 15 2012 Current OBYES

CEFACLORCAPSULEORALCECLOR

DISC LILLY EQ 250MG BASE N 050521 001 Oct 01 2008 Current OBYESDISC EQ 500MG BASE N 050521 002 Oct 01 2008 Current OBYESFOR SUSPENSIONORALCECLOR

DISC LILLY EQ 125MG BASE5ML N 050522 001 Oct 01 2008 Current OBYESDISC EQ 250MG BASE5ML N 050522 002 Oct 01 2008 Current OBYES

CEFADROXILCEFADROXIL HEMIHYDRATECAPSULEORALDURICEF

DISC WARNER CHILCOTT EQ 500MG BASE N 050512 001 Mar 26 2007 Current OBYESFOR SUSPENSIONORALDURICEF

DISC WARNER CHILCOTT EQ 125MG BASE5ML N 050527 002 Mar 02 2011 Current OBYESDISC EQ 250MG BASE5ML N 050527 003 Mar 02 2011 Current OBYESDISC EQ 500MG BASE5ML N 050527 001 Mar 02 2011 Current OBYESTABLETORALDURICEF

DISC WARNER CHILCOTT EQ 1GM BASE N 050528 001 Mar 26 2007 Current OBYES

CEFAZOLIN SODIUMINJECTABLEINJECTIONANCEF

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL N 050461 003 Oct 30 2015 Current OBYESDISC EQ 5GM BASEVIAL N 050461 004 Mar 07 2008 Current OBYESDISC EQ 10GM BASEVIAL N 050461 005 Oct 30 2015 Current OBYESDISC EQ 250MG BASEVIAL N 050461 001 Mar 07 2008 Current OBYESDISC EQ 500MG BASEVIAL N 050461 002 Mar 07 2008 Current OBNO

CEFAZOLIN SODIUMDISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 064169 002 Oct 30 2015 Current OBYESDISC EQ 500MG BASEVIAL A 064169 001 Oct 30 2015 Current OBYES

CEFDINIRCAPSULEORALOMNICEF

DISC ABBVIE 300MG N 050739 001 Nov 18 2016 Current OBYESFOR SUSPENSIONORALOMNICEF

DISC ABBVIE 125MG5ML N 050749 001 Nov 18 2016 Current OBYESDISC 250MG5ML N 050749 002 Nov 18 2016 Current OBYES

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December 2016 Page 11 of 50

CEFIXIMEFOR SUSPENSIONORALSUPRAX

DISC LEDERLE 100MG5ML N 050622 001 Feb 18 2004 Current OBYESTABLETORALSUPRAX

DISC LEDERLE 200MG N 050621 001 Feb 18 2004 Current OBYESDISC 400MG N 050621 002 Feb 18 2004 Current OBYES

CEFMETAZOLE SODIUMINJECTABLEINJECTIONZEFAZONE

DISC PHARMACIA AND EQ 1GM BASEVIAL N 050637 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 2GM BASEVIAL N 050637 002 Mar 10 2014 Current OBYESZEFAZONE IN PLASTIC CONTAINER

DISC PHARMACIA AND EQ 20MG BASEML N 050683 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 40MG BASEML N 050683 002 Mar 10 2014 Current OBYES

CEFOTETAN DISODIUMINJECTABLEINJECTIONCEFOTAN

RX TELIGENT PHARMA EQ 1GM BASEVIAL N 050588 001 Jun 07 2007 Current OBNOINC

RX EQ 2GM BASEVIAL N 050588 002 Jun 07 2007 Current OBNO

CEFOXITIN SODIUMINJECTABLEINJECTIONCEFOXITIN

DISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 065012 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 065012 002 May 04 2016 Current OBYES

MEFOXINDISC MYLAN EQ 1GM BASEVIAL N 050517 001 Mar 11 2010 Current OBYES

INSTITUTIONALDISC EQ 2GM BASEVIAL N 050517 002 Mar 11 2010 Current OBYESDISC EQ 10GM BASEVIAL N 050517 003 Sep 06 2007 Current OBYES

CEFPODOXIME PROXETILFOR SUSPENSIONORALVANTIN

DISC PHARMACIA AND EQ 50MG BASE5ML N 050675 001 Jan 21 2016 Current OBYESUPJOHN

DISC EQ 100MG BASE5ML N 050675 002 Jan 21 2016 Current OBYES

CEFTRIAXONE SODIUMINJECTABLEINJECTIONROCEPHIN

DISC HOFFMANN LA ROCHE EQ 10GM BASEVIAL N 050585 005 Mar 15 2011 Current OBNOROCEPHIN W DEXTROSE IN PLASTIC CONTAINER

DISC HOFFMANN LA ROCHE EQ 10MG BASEML N 050624 001 Nov 18 2016 Current OBYESDISC EQ 20MG BASEML N 050624 002 Nov 18 2016 Current OBYESDISC EQ 40MG BASEML N 050624 003 Nov 18 2016 Current OBYESINJECTABLEINTRAMUSCULAR INTRAVENOUSROCEPHIN

DISC HOFFMANN LA ROCHE EQ 1GM BASEVIAL N 050585 003 Mar 15 2011 Current OBNODISC EQ 2GM BASEVIAL N 050585 004 Mar 15 2011 Current OBNODISC EQ 250MG BASEVIAL N 050585 001 Mar 15 2011 Current OBNODISC EQ 500MG BASEVIAL N 050585 002 Mar 15 2011 Current OBNO

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December 2016 Page 12 of 50

CEPHALEXINCAPSULEORALKEFLEX

DISC PRAGMA PHARMS LLC EQ 333MG BASE N 050405 004 Apr 12 2011 Current OBYESFOR SUSPENSIONORALCEPHALEXIN

DISC FACTA FARMA EQ 100MG BASEML A 062117 001 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML A 062117 002 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML A 062117 003 Mar 15 2016 Current OBYES

KEFLEXDISC PRAGMA PHARMS LLC EQ 100MG BASEML N 050406 003 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML N 050406 001 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML N 050406 002 Mar 15 2016 Current OBYES

CHENODIOLTABLETORALCHENIX

DISC SIGMA TAU 250MG N 018513 002 May 23 2007 Current OBYES

CHLOROTHIAZIDESUSPENSIONORALDIURIL

RX SALIX PHARMS 250MG5ML N 011870 001 May 23 2007 Current OBNOTABLETORALDIURIL

DISC OAK PHARMS AKORN 250MG N 011145 004 May 23 2007 Current OBYESDISC 500MG N 011145 002 May 23 2007 Current OBYES

CHLORPROMAZINESUPPOSITORYRECTALTHORAZINE

DISC GLAXOSMITHKLINE 25MG N 009149 024 Jun 15 2009 Current OBYESDISC 100MG N 009149 033 Jun 15 2009 Current OBYES

CHLORPROMAZINE HYDROCHLORIDECONCENTRATEORALTHORAZINE

DISC GLAXOSMITHKLINE 30MGML N 009149 032 Jun 15 2009 Current OBYESDISC 100MGML N 009149 043 Jun 15 2009 Current OBYESINJECTABLEINJECTIONTHORAZINE

DISC GLAXOSMITHKLINE 25MGML N 009149 011 Jun 15 2009 Current OBYESSYRUPORALTHORAZINE

DISC GLAXOSMITHKLINE 10MG5ML N 009149 022 Jun 15 2009 Current OBYESTABLETORALCHLORPROMAZINE HYDROCHLORIDE

DISC SANDOZ 10MG A 080439 001 Jan 21 2016 Current OBYESDISC 25MG A 080439 002 Jan 21 2016 Current OBYESDISC 50MG A 080439 003 Jan 21 2016 Current OBYESDISC 100MG A 080439 004 Jan 21 2016 Current OBYESDISC 200MG A 080439 005 Jan 21 2016 Current OBYES

THORAZINEDISC GLAXOSMITHKLINE 10MG N 009149 002 May 23 2007 Current OBYESDISC 25MG N 009149 007 May 23 2007 Current OBYESDISC 50MG N 009149 013 May 23 2007 Current OBYESDISC 100MG N 009149 018 May 23 2007 Current OBYESDISC 200MG N 009149 020 May 23 2007 Current OBYES

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December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

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December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

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December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

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December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

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December 2016 Page 17 of 50

DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

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December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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December 2016 Page 21 of 50

TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 8: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 8 of 50

BRETYLIUM TOSYLATEINJECTABLEINJECTIONBRETYLIUM TOSYLATE

DISC HOSPIRA 50MGML N 019030 001 Dec 19 2011 Current OBYES

BRIMONIDINE TARTRATESOLUTIONDROPSOPHTHALMICALPHAGAN

DISC ALLERGAN 02 N 020613 001 Jun 11 2003 Current OBYES

BROMFENAC SODIUMSOLUTIONDROPSOPHTHALMICBROMDAY

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 002 Dec 04 2015 Current OBYESINCXIBROM

DISC BAUSCH AND LOMB EQ 009 ACID N 021664 001 May 13 2011 Current OBYESINC

BROMOCRIPTINE MESYLATECAPSULEORALPARLODEL

RX US PHARMS HOLDINGS EQ 5MG BASE N 017962 002 Sep 06 2016 Current OBYESI

BROMPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PSEUDOEPHEDRINE HYDROCHLORIDESYRUPORALDIMETANE-DX

DISC ROBINS AH 2MG5ML10MG5ML30MG5ML N 019279 001 May 04 2016 Current OBYES

BUMETANIDEINJECTABLEINJECTIONBUMEX

DISC VALIDUS PHARMS INC 025MGML N 018226 001 Sep 06 2007 Current OBYESTABLETORALBUMEX

RX VALIDUS PHARMS INC 05MG N 018225 002 Oct 30 2015 Current OBYESRX 1MG N 018225 001 Oct 30 2015 Current OBYESRX 2MG N 018225 003 Oct 30 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDETABLETSUBLINGUALSUBUTEX

DISC INDIVIOR INC EQ 2MG BASE N 020732 002 Feb 13 2015 Current OBYESDISC EQ 8MG BASE N 020732 003 Feb 13 2015 Current OBYES

BUPRENORPHINE HYDROCHLORIDE NALOXONE HYDROCHLORIDETABLETSUBLINGUALSUBOXONE

DISC INDIVIOR INC EQ 2MG BASEEQ 05MG BASE N 020733 001 Jun 06 2013 Current OBYESDISC EQ 8MG BASEEQ 2MG BASE N 020733 002 Jun 06 2013 Current OBNO

BUSPIRONE HYDROCHLORIDETABLETORALBUSPAR

DISC

DISC

BRISTOL MYERS

SQUIBB

5MG

10MG

N 018731 001 Sep 06 2016 Current OBYES

N 018731 002 Oct 19 2010 Current OBYES

DISC 15MG N 018731 003 Oct 19 2010 Current OBYES

DISC 30MG N 018731 004 Oct 19 2010 Current OBYES

BUSPIRONE HYDROCHLORIDE

DISC IVAX SUB TEVA

PHARMS

5MG A 075385 001 Sep 06 2016 Current OBYES

DISC

DISC

10MG

15MG

A 075385 002 Sep 06 2016 Current OBYES

A 075385 003 Sep 06 2016 Current OBYES

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December 2016 Page 9 of 50

CABERGOLINE

TABLETORAL

DOSTINEX

DISC PHARMACIA AND

UPJOHN

05MG N 020664 001 Mar 11 2010 Current OBYES

CAFFEINE ERGOTAMINE TARTRATE

SUPPOSITORYRECTAL

CAFERGOT

DISC NOVARTIS 100MG2MG N 009000 002 Apr 28 2008 Current OBYES

CALCIPOTRIENE

OINTMENTTOPICAL

DOVONEX

LEO PHARMA ASDISC

SOLUTIONTOPICAL

DOVONEX

0005 N 020273 001 Mar 09 2010 Current OBYES

LEO PHARMDISC 0005 N 020611 001 Oct 31 2014 Current OBYES

CALCIUM ACETATE

TABLETORAL

PHOSLO

DISC FRESENIUS MEDCL 667MG N 019976 001 Aug 06 2007 Current OBYES

CALCIUM CARBONATE RISEDRONATE SODIUM

TABLET TABLETORAL

ACTONEL WITH CALCIUM (COPACKAGED)

WARNER CHILCOTT EQ 500MG BASENANA35MGDISC N 021823 001 Jul 07 2010 Current OBYES

CAPTOPRIL

TABLETORAL

CAPOTEN

DISC

DISC

DISC

DISC

DISC

DISC

DISC

PAR PHARM 125MG

25MG

375MG

50MG

75MG

100MG

150MG

N 018343 005 Oct 30 2015 Current OBYES

N 018343 002 Oct 30 2015 Current OBYES

N 018343 006 Jan 21 2016 Current OBYES

N 018343 001 Oct 30 2015 Current OBYES

N 018343 007 Jan 21 2016 Current OBYES

N 018343 003 Oct 30 2015 Current OBYES

N 018343 004 Jan 21 2016 Current OBYES

CAPTOPRIL HYDROCHLOROTHIAZIDE

TABLETORAL

CAPOZIDE 2515

APOTHECON 25MG15MGDISC

CAPOZIDE 2525

APOTHECON 25MG25MGDISC

CAPOZIDE 5015

APOTHECON 50MG15MGDISC

CAPOZIDE 5025

APOTHECON 50MG25MGDISC

N 018709 001 Jan 09 2015 Current OBYES

N 018709 002 Jan 09 2015 Current OBYES

N 018709 004 Jan 09 2015 Current OBYES

N 018709 003 Jan 09 2015 Current OBYES

CARBIDOPA LEVODOPA

TABLET ORALLY DISINTEGRATINGORAL

PARCOPA

DISC

DISC

DISC

UCB INC 10MG100MG

25MG100MG

25MG250MG

A 076699 001 Jan 09 2015 Current OBYES

A 076699 002 Jan 09 2015 Current OBYES

A 076699 003 Jan 09 2015 Current OBYES

CARBINOXAMINE MALEATE

ELIXIRORAL

CLISTIN

DISC MCNEIL 4MG5ML N 008955 001 Apr 10 2000 Current OBYES

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December 2016 Page 10 of 50

TABLETORALCLISTIN

DISC ORTHO MCNEIL PHARM 4MG N 008915 001 May 21 1998 Current OBYES

CARBOPLATININJECTABLEINJECTIONPARAPLATIN

DISC CORDEN PHARMA 50MGVIAL N 019880 001 Dec 19 2008 Current OBYESDISC 150MGVIAL N 019880 002 Dec 19 2008 Current OBYESDISC 450MGVIAL N 019880 003 Dec 19 2008 Current OBYESINJECTABLEIV (INFUSION)PARAPLATIN

DISC CORDENPHARMA 50MG5ML (10MGML) N 020452 001 Jun 15 2012 Current OBYESDISC 150MG15ML (10MGML) N 020452 002 Jun 15 2012 Current OBYESDISC 450MG45ML (10MGML) N 020452 003 Jun 15 2012 Current OBYESDISC 600MG60ML (10MGML) N 020452 004 Jun 15 2012 Current OBYES

CEFACLORCAPSULEORALCECLOR

DISC LILLY EQ 250MG BASE N 050521 001 Oct 01 2008 Current OBYESDISC EQ 500MG BASE N 050521 002 Oct 01 2008 Current OBYESFOR SUSPENSIONORALCECLOR

DISC LILLY EQ 125MG BASE5ML N 050522 001 Oct 01 2008 Current OBYESDISC EQ 250MG BASE5ML N 050522 002 Oct 01 2008 Current OBYES

CEFADROXILCEFADROXIL HEMIHYDRATECAPSULEORALDURICEF

DISC WARNER CHILCOTT EQ 500MG BASE N 050512 001 Mar 26 2007 Current OBYESFOR SUSPENSIONORALDURICEF

DISC WARNER CHILCOTT EQ 125MG BASE5ML N 050527 002 Mar 02 2011 Current OBYESDISC EQ 250MG BASE5ML N 050527 003 Mar 02 2011 Current OBYESDISC EQ 500MG BASE5ML N 050527 001 Mar 02 2011 Current OBYESTABLETORALDURICEF

DISC WARNER CHILCOTT EQ 1GM BASE N 050528 001 Mar 26 2007 Current OBYES

CEFAZOLIN SODIUMINJECTABLEINJECTIONANCEF

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL N 050461 003 Oct 30 2015 Current OBYESDISC EQ 5GM BASEVIAL N 050461 004 Mar 07 2008 Current OBYESDISC EQ 10GM BASEVIAL N 050461 005 Oct 30 2015 Current OBYESDISC EQ 250MG BASEVIAL N 050461 001 Mar 07 2008 Current OBYESDISC EQ 500MG BASEVIAL N 050461 002 Mar 07 2008 Current OBNO

CEFAZOLIN SODIUMDISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 064169 002 Oct 30 2015 Current OBYESDISC EQ 500MG BASEVIAL A 064169 001 Oct 30 2015 Current OBYES

CEFDINIRCAPSULEORALOMNICEF

DISC ABBVIE 300MG N 050739 001 Nov 18 2016 Current OBYESFOR SUSPENSIONORALOMNICEF

DISC ABBVIE 125MG5ML N 050749 001 Nov 18 2016 Current OBYESDISC 250MG5ML N 050749 002 Nov 18 2016 Current OBYES

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December 2016 Page 11 of 50

CEFIXIMEFOR SUSPENSIONORALSUPRAX

DISC LEDERLE 100MG5ML N 050622 001 Feb 18 2004 Current OBYESTABLETORALSUPRAX

DISC LEDERLE 200MG N 050621 001 Feb 18 2004 Current OBYESDISC 400MG N 050621 002 Feb 18 2004 Current OBYES

CEFMETAZOLE SODIUMINJECTABLEINJECTIONZEFAZONE

DISC PHARMACIA AND EQ 1GM BASEVIAL N 050637 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 2GM BASEVIAL N 050637 002 Mar 10 2014 Current OBYESZEFAZONE IN PLASTIC CONTAINER

DISC PHARMACIA AND EQ 20MG BASEML N 050683 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 40MG BASEML N 050683 002 Mar 10 2014 Current OBYES

CEFOTETAN DISODIUMINJECTABLEINJECTIONCEFOTAN

RX TELIGENT PHARMA EQ 1GM BASEVIAL N 050588 001 Jun 07 2007 Current OBNOINC

RX EQ 2GM BASEVIAL N 050588 002 Jun 07 2007 Current OBNO

CEFOXITIN SODIUMINJECTABLEINJECTIONCEFOXITIN

DISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 065012 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 065012 002 May 04 2016 Current OBYES

MEFOXINDISC MYLAN EQ 1GM BASEVIAL N 050517 001 Mar 11 2010 Current OBYES

INSTITUTIONALDISC EQ 2GM BASEVIAL N 050517 002 Mar 11 2010 Current OBYESDISC EQ 10GM BASEVIAL N 050517 003 Sep 06 2007 Current OBYES

CEFPODOXIME PROXETILFOR SUSPENSIONORALVANTIN

DISC PHARMACIA AND EQ 50MG BASE5ML N 050675 001 Jan 21 2016 Current OBYESUPJOHN

DISC EQ 100MG BASE5ML N 050675 002 Jan 21 2016 Current OBYES

CEFTRIAXONE SODIUMINJECTABLEINJECTIONROCEPHIN

DISC HOFFMANN LA ROCHE EQ 10GM BASEVIAL N 050585 005 Mar 15 2011 Current OBNOROCEPHIN W DEXTROSE IN PLASTIC CONTAINER

DISC HOFFMANN LA ROCHE EQ 10MG BASEML N 050624 001 Nov 18 2016 Current OBYESDISC EQ 20MG BASEML N 050624 002 Nov 18 2016 Current OBYESDISC EQ 40MG BASEML N 050624 003 Nov 18 2016 Current OBYESINJECTABLEINTRAMUSCULAR INTRAVENOUSROCEPHIN

DISC HOFFMANN LA ROCHE EQ 1GM BASEVIAL N 050585 003 Mar 15 2011 Current OBNODISC EQ 2GM BASEVIAL N 050585 004 Mar 15 2011 Current OBNODISC EQ 250MG BASEVIAL N 050585 001 Mar 15 2011 Current OBNODISC EQ 500MG BASEVIAL N 050585 002 Mar 15 2011 Current OBNO

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December 2016 Page 12 of 50

CEPHALEXINCAPSULEORALKEFLEX

DISC PRAGMA PHARMS LLC EQ 333MG BASE N 050405 004 Apr 12 2011 Current OBYESFOR SUSPENSIONORALCEPHALEXIN

DISC FACTA FARMA EQ 100MG BASEML A 062117 001 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML A 062117 002 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML A 062117 003 Mar 15 2016 Current OBYES

KEFLEXDISC PRAGMA PHARMS LLC EQ 100MG BASEML N 050406 003 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML N 050406 001 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML N 050406 002 Mar 15 2016 Current OBYES

CHENODIOLTABLETORALCHENIX

DISC SIGMA TAU 250MG N 018513 002 May 23 2007 Current OBYES

CHLOROTHIAZIDESUSPENSIONORALDIURIL

RX SALIX PHARMS 250MG5ML N 011870 001 May 23 2007 Current OBNOTABLETORALDIURIL

DISC OAK PHARMS AKORN 250MG N 011145 004 May 23 2007 Current OBYESDISC 500MG N 011145 002 May 23 2007 Current OBYES

CHLORPROMAZINESUPPOSITORYRECTALTHORAZINE

DISC GLAXOSMITHKLINE 25MG N 009149 024 Jun 15 2009 Current OBYESDISC 100MG N 009149 033 Jun 15 2009 Current OBYES

CHLORPROMAZINE HYDROCHLORIDECONCENTRATEORALTHORAZINE

DISC GLAXOSMITHKLINE 30MGML N 009149 032 Jun 15 2009 Current OBYESDISC 100MGML N 009149 043 Jun 15 2009 Current OBYESINJECTABLEINJECTIONTHORAZINE

DISC GLAXOSMITHKLINE 25MGML N 009149 011 Jun 15 2009 Current OBYESSYRUPORALTHORAZINE

DISC GLAXOSMITHKLINE 10MG5ML N 009149 022 Jun 15 2009 Current OBYESTABLETORALCHLORPROMAZINE HYDROCHLORIDE

DISC SANDOZ 10MG A 080439 001 Jan 21 2016 Current OBYESDISC 25MG A 080439 002 Jan 21 2016 Current OBYESDISC 50MG A 080439 003 Jan 21 2016 Current OBYESDISC 100MG A 080439 004 Jan 21 2016 Current OBYESDISC 200MG A 080439 005 Jan 21 2016 Current OBYES

THORAZINEDISC GLAXOSMITHKLINE 10MG N 009149 002 May 23 2007 Current OBYESDISC 25MG N 009149 007 May 23 2007 Current OBYESDISC 50MG N 009149 013 May 23 2007 Current OBYESDISC 100MG N 009149 018 May 23 2007 Current OBYESDISC 200MG N 009149 020 May 23 2007 Current OBYES

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December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

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December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

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December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

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December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

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DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

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December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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December 2016 Page 21 of 50

TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

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December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

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December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

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December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

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December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

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December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 9: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 9 of 50

CABERGOLINE

TABLETORAL

DOSTINEX

DISC PHARMACIA AND

UPJOHN

05MG N 020664 001 Mar 11 2010 Current OBYES

CAFFEINE ERGOTAMINE TARTRATE

SUPPOSITORYRECTAL

CAFERGOT

DISC NOVARTIS 100MG2MG N 009000 002 Apr 28 2008 Current OBYES

CALCIPOTRIENE

OINTMENTTOPICAL

DOVONEX

LEO PHARMA ASDISC

SOLUTIONTOPICAL

DOVONEX

0005 N 020273 001 Mar 09 2010 Current OBYES

LEO PHARMDISC 0005 N 020611 001 Oct 31 2014 Current OBYES

CALCIUM ACETATE

TABLETORAL

PHOSLO

DISC FRESENIUS MEDCL 667MG N 019976 001 Aug 06 2007 Current OBYES

CALCIUM CARBONATE RISEDRONATE SODIUM

TABLET TABLETORAL

ACTONEL WITH CALCIUM (COPACKAGED)

WARNER CHILCOTT EQ 500MG BASENANA35MGDISC N 021823 001 Jul 07 2010 Current OBYES

CAPTOPRIL

TABLETORAL

CAPOTEN

DISC

DISC

DISC

DISC

DISC

DISC

DISC

PAR PHARM 125MG

25MG

375MG

50MG

75MG

100MG

150MG

N 018343 005 Oct 30 2015 Current OBYES

N 018343 002 Oct 30 2015 Current OBYES

N 018343 006 Jan 21 2016 Current OBYES

N 018343 001 Oct 30 2015 Current OBYES

N 018343 007 Jan 21 2016 Current OBYES

N 018343 003 Oct 30 2015 Current OBYES

N 018343 004 Jan 21 2016 Current OBYES

CAPTOPRIL HYDROCHLOROTHIAZIDE

TABLETORAL

CAPOZIDE 2515

APOTHECON 25MG15MGDISC

CAPOZIDE 2525

APOTHECON 25MG25MGDISC

CAPOZIDE 5015

APOTHECON 50MG15MGDISC

CAPOZIDE 5025

APOTHECON 50MG25MGDISC

N 018709 001 Jan 09 2015 Current OBYES

N 018709 002 Jan 09 2015 Current OBYES

N 018709 004 Jan 09 2015 Current OBYES

N 018709 003 Jan 09 2015 Current OBYES

CARBIDOPA LEVODOPA

TABLET ORALLY DISINTEGRATINGORAL

PARCOPA

DISC

DISC

DISC

UCB INC 10MG100MG

25MG100MG

25MG250MG

A 076699 001 Jan 09 2015 Current OBYES

A 076699 002 Jan 09 2015 Current OBYES

A 076699 003 Jan 09 2015 Current OBYES

CARBINOXAMINE MALEATE

ELIXIRORAL

CLISTIN

DISC MCNEIL 4MG5ML N 008955 001 Apr 10 2000 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 10 of 50

TABLETORALCLISTIN

DISC ORTHO MCNEIL PHARM 4MG N 008915 001 May 21 1998 Current OBYES

CARBOPLATININJECTABLEINJECTIONPARAPLATIN

DISC CORDEN PHARMA 50MGVIAL N 019880 001 Dec 19 2008 Current OBYESDISC 150MGVIAL N 019880 002 Dec 19 2008 Current OBYESDISC 450MGVIAL N 019880 003 Dec 19 2008 Current OBYESINJECTABLEIV (INFUSION)PARAPLATIN

DISC CORDENPHARMA 50MG5ML (10MGML) N 020452 001 Jun 15 2012 Current OBYESDISC 150MG15ML (10MGML) N 020452 002 Jun 15 2012 Current OBYESDISC 450MG45ML (10MGML) N 020452 003 Jun 15 2012 Current OBYESDISC 600MG60ML (10MGML) N 020452 004 Jun 15 2012 Current OBYES

CEFACLORCAPSULEORALCECLOR

DISC LILLY EQ 250MG BASE N 050521 001 Oct 01 2008 Current OBYESDISC EQ 500MG BASE N 050521 002 Oct 01 2008 Current OBYESFOR SUSPENSIONORALCECLOR

DISC LILLY EQ 125MG BASE5ML N 050522 001 Oct 01 2008 Current OBYESDISC EQ 250MG BASE5ML N 050522 002 Oct 01 2008 Current OBYES

CEFADROXILCEFADROXIL HEMIHYDRATECAPSULEORALDURICEF

DISC WARNER CHILCOTT EQ 500MG BASE N 050512 001 Mar 26 2007 Current OBYESFOR SUSPENSIONORALDURICEF

DISC WARNER CHILCOTT EQ 125MG BASE5ML N 050527 002 Mar 02 2011 Current OBYESDISC EQ 250MG BASE5ML N 050527 003 Mar 02 2011 Current OBYESDISC EQ 500MG BASE5ML N 050527 001 Mar 02 2011 Current OBYESTABLETORALDURICEF

DISC WARNER CHILCOTT EQ 1GM BASE N 050528 001 Mar 26 2007 Current OBYES

CEFAZOLIN SODIUMINJECTABLEINJECTIONANCEF

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL N 050461 003 Oct 30 2015 Current OBYESDISC EQ 5GM BASEVIAL N 050461 004 Mar 07 2008 Current OBYESDISC EQ 10GM BASEVIAL N 050461 005 Oct 30 2015 Current OBYESDISC EQ 250MG BASEVIAL N 050461 001 Mar 07 2008 Current OBYESDISC EQ 500MG BASEVIAL N 050461 002 Mar 07 2008 Current OBNO

CEFAZOLIN SODIUMDISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 064169 002 Oct 30 2015 Current OBYESDISC EQ 500MG BASEVIAL A 064169 001 Oct 30 2015 Current OBYES

CEFDINIRCAPSULEORALOMNICEF

DISC ABBVIE 300MG N 050739 001 Nov 18 2016 Current OBYESFOR SUSPENSIONORALOMNICEF

DISC ABBVIE 125MG5ML N 050749 001 Nov 18 2016 Current OBYESDISC 250MG5ML N 050749 002 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 11 of 50

CEFIXIMEFOR SUSPENSIONORALSUPRAX

DISC LEDERLE 100MG5ML N 050622 001 Feb 18 2004 Current OBYESTABLETORALSUPRAX

DISC LEDERLE 200MG N 050621 001 Feb 18 2004 Current OBYESDISC 400MG N 050621 002 Feb 18 2004 Current OBYES

CEFMETAZOLE SODIUMINJECTABLEINJECTIONZEFAZONE

DISC PHARMACIA AND EQ 1GM BASEVIAL N 050637 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 2GM BASEVIAL N 050637 002 Mar 10 2014 Current OBYESZEFAZONE IN PLASTIC CONTAINER

DISC PHARMACIA AND EQ 20MG BASEML N 050683 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 40MG BASEML N 050683 002 Mar 10 2014 Current OBYES

CEFOTETAN DISODIUMINJECTABLEINJECTIONCEFOTAN

RX TELIGENT PHARMA EQ 1GM BASEVIAL N 050588 001 Jun 07 2007 Current OBNOINC

RX EQ 2GM BASEVIAL N 050588 002 Jun 07 2007 Current OBNO

CEFOXITIN SODIUMINJECTABLEINJECTIONCEFOXITIN

DISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 065012 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 065012 002 May 04 2016 Current OBYES

MEFOXINDISC MYLAN EQ 1GM BASEVIAL N 050517 001 Mar 11 2010 Current OBYES

INSTITUTIONALDISC EQ 2GM BASEVIAL N 050517 002 Mar 11 2010 Current OBYESDISC EQ 10GM BASEVIAL N 050517 003 Sep 06 2007 Current OBYES

CEFPODOXIME PROXETILFOR SUSPENSIONORALVANTIN

DISC PHARMACIA AND EQ 50MG BASE5ML N 050675 001 Jan 21 2016 Current OBYESUPJOHN

DISC EQ 100MG BASE5ML N 050675 002 Jan 21 2016 Current OBYES

CEFTRIAXONE SODIUMINJECTABLEINJECTIONROCEPHIN

DISC HOFFMANN LA ROCHE EQ 10GM BASEVIAL N 050585 005 Mar 15 2011 Current OBNOROCEPHIN W DEXTROSE IN PLASTIC CONTAINER

DISC HOFFMANN LA ROCHE EQ 10MG BASEML N 050624 001 Nov 18 2016 Current OBYESDISC EQ 20MG BASEML N 050624 002 Nov 18 2016 Current OBYESDISC EQ 40MG BASEML N 050624 003 Nov 18 2016 Current OBYESINJECTABLEINTRAMUSCULAR INTRAVENOUSROCEPHIN

DISC HOFFMANN LA ROCHE EQ 1GM BASEVIAL N 050585 003 Mar 15 2011 Current OBNODISC EQ 2GM BASEVIAL N 050585 004 Mar 15 2011 Current OBNODISC EQ 250MG BASEVIAL N 050585 001 Mar 15 2011 Current OBNODISC EQ 500MG BASEVIAL N 050585 002 Mar 15 2011 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 12 of 50

CEPHALEXINCAPSULEORALKEFLEX

DISC PRAGMA PHARMS LLC EQ 333MG BASE N 050405 004 Apr 12 2011 Current OBYESFOR SUSPENSIONORALCEPHALEXIN

DISC FACTA FARMA EQ 100MG BASEML A 062117 001 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML A 062117 002 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML A 062117 003 Mar 15 2016 Current OBYES

KEFLEXDISC PRAGMA PHARMS LLC EQ 100MG BASEML N 050406 003 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML N 050406 001 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML N 050406 002 Mar 15 2016 Current OBYES

CHENODIOLTABLETORALCHENIX

DISC SIGMA TAU 250MG N 018513 002 May 23 2007 Current OBYES

CHLOROTHIAZIDESUSPENSIONORALDIURIL

RX SALIX PHARMS 250MG5ML N 011870 001 May 23 2007 Current OBNOTABLETORALDIURIL

DISC OAK PHARMS AKORN 250MG N 011145 004 May 23 2007 Current OBYESDISC 500MG N 011145 002 May 23 2007 Current OBYES

CHLORPROMAZINESUPPOSITORYRECTALTHORAZINE

DISC GLAXOSMITHKLINE 25MG N 009149 024 Jun 15 2009 Current OBYESDISC 100MG N 009149 033 Jun 15 2009 Current OBYES

CHLORPROMAZINE HYDROCHLORIDECONCENTRATEORALTHORAZINE

DISC GLAXOSMITHKLINE 30MGML N 009149 032 Jun 15 2009 Current OBYESDISC 100MGML N 009149 043 Jun 15 2009 Current OBYESINJECTABLEINJECTIONTHORAZINE

DISC GLAXOSMITHKLINE 25MGML N 009149 011 Jun 15 2009 Current OBYESSYRUPORALTHORAZINE

DISC GLAXOSMITHKLINE 10MG5ML N 009149 022 Jun 15 2009 Current OBYESTABLETORALCHLORPROMAZINE HYDROCHLORIDE

DISC SANDOZ 10MG A 080439 001 Jan 21 2016 Current OBYESDISC 25MG A 080439 002 Jan 21 2016 Current OBYESDISC 50MG A 080439 003 Jan 21 2016 Current OBYESDISC 100MG A 080439 004 Jan 21 2016 Current OBYESDISC 200MG A 080439 005 Jan 21 2016 Current OBYES

THORAZINEDISC GLAXOSMITHKLINE 10MG N 009149 002 May 23 2007 Current OBYESDISC 25MG N 009149 007 May 23 2007 Current OBYESDISC 50MG N 009149 013 May 23 2007 Current OBYESDISC 100MG N 009149 018 May 23 2007 Current OBYESDISC 200MG N 009149 020 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 17 of 50

DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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See List Footnote

December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

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December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

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December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 10: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 10 of 50

TABLETORALCLISTIN

DISC ORTHO MCNEIL PHARM 4MG N 008915 001 May 21 1998 Current OBYES

CARBOPLATININJECTABLEINJECTIONPARAPLATIN

DISC CORDEN PHARMA 50MGVIAL N 019880 001 Dec 19 2008 Current OBYESDISC 150MGVIAL N 019880 002 Dec 19 2008 Current OBYESDISC 450MGVIAL N 019880 003 Dec 19 2008 Current OBYESINJECTABLEIV (INFUSION)PARAPLATIN

DISC CORDENPHARMA 50MG5ML (10MGML) N 020452 001 Jun 15 2012 Current OBYESDISC 150MG15ML (10MGML) N 020452 002 Jun 15 2012 Current OBYESDISC 450MG45ML (10MGML) N 020452 003 Jun 15 2012 Current OBYESDISC 600MG60ML (10MGML) N 020452 004 Jun 15 2012 Current OBYES

CEFACLORCAPSULEORALCECLOR

DISC LILLY EQ 250MG BASE N 050521 001 Oct 01 2008 Current OBYESDISC EQ 500MG BASE N 050521 002 Oct 01 2008 Current OBYESFOR SUSPENSIONORALCECLOR

DISC LILLY EQ 125MG BASE5ML N 050522 001 Oct 01 2008 Current OBYESDISC EQ 250MG BASE5ML N 050522 002 Oct 01 2008 Current OBYES

CEFADROXILCEFADROXIL HEMIHYDRATECAPSULEORALDURICEF

DISC WARNER CHILCOTT EQ 500MG BASE N 050512 001 Mar 26 2007 Current OBYESFOR SUSPENSIONORALDURICEF

DISC WARNER CHILCOTT EQ 125MG BASE5ML N 050527 002 Mar 02 2011 Current OBYESDISC EQ 250MG BASE5ML N 050527 003 Mar 02 2011 Current OBYESDISC EQ 500MG BASE5ML N 050527 001 Mar 02 2011 Current OBYESTABLETORALDURICEF

DISC WARNER CHILCOTT EQ 1GM BASE N 050528 001 Mar 26 2007 Current OBYES

CEFAZOLIN SODIUMINJECTABLEINJECTIONANCEF

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL N 050461 003 Oct 30 2015 Current OBYESDISC EQ 5GM BASEVIAL N 050461 004 Mar 07 2008 Current OBYESDISC EQ 10GM BASEVIAL N 050461 005 Oct 30 2015 Current OBYESDISC EQ 250MG BASEVIAL N 050461 001 Mar 07 2008 Current OBYESDISC EQ 500MG BASEVIAL N 050461 002 Mar 07 2008 Current OBNO

CEFAZOLIN SODIUMDISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 064169 002 Oct 30 2015 Current OBYESDISC EQ 500MG BASEVIAL A 064169 001 Oct 30 2015 Current OBYES

CEFDINIRCAPSULEORALOMNICEF

DISC ABBVIE 300MG N 050739 001 Nov 18 2016 Current OBYESFOR SUSPENSIONORALOMNICEF

DISC ABBVIE 125MG5ML N 050749 001 Nov 18 2016 Current OBYESDISC 250MG5ML N 050749 002 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 11 of 50

CEFIXIMEFOR SUSPENSIONORALSUPRAX

DISC LEDERLE 100MG5ML N 050622 001 Feb 18 2004 Current OBYESTABLETORALSUPRAX

DISC LEDERLE 200MG N 050621 001 Feb 18 2004 Current OBYESDISC 400MG N 050621 002 Feb 18 2004 Current OBYES

CEFMETAZOLE SODIUMINJECTABLEINJECTIONZEFAZONE

DISC PHARMACIA AND EQ 1GM BASEVIAL N 050637 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 2GM BASEVIAL N 050637 002 Mar 10 2014 Current OBYESZEFAZONE IN PLASTIC CONTAINER

DISC PHARMACIA AND EQ 20MG BASEML N 050683 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 40MG BASEML N 050683 002 Mar 10 2014 Current OBYES

CEFOTETAN DISODIUMINJECTABLEINJECTIONCEFOTAN

RX TELIGENT PHARMA EQ 1GM BASEVIAL N 050588 001 Jun 07 2007 Current OBNOINC

RX EQ 2GM BASEVIAL N 050588 002 Jun 07 2007 Current OBNO

CEFOXITIN SODIUMINJECTABLEINJECTIONCEFOXITIN

DISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 065012 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 065012 002 May 04 2016 Current OBYES

MEFOXINDISC MYLAN EQ 1GM BASEVIAL N 050517 001 Mar 11 2010 Current OBYES

INSTITUTIONALDISC EQ 2GM BASEVIAL N 050517 002 Mar 11 2010 Current OBYESDISC EQ 10GM BASEVIAL N 050517 003 Sep 06 2007 Current OBYES

CEFPODOXIME PROXETILFOR SUSPENSIONORALVANTIN

DISC PHARMACIA AND EQ 50MG BASE5ML N 050675 001 Jan 21 2016 Current OBYESUPJOHN

DISC EQ 100MG BASE5ML N 050675 002 Jan 21 2016 Current OBYES

CEFTRIAXONE SODIUMINJECTABLEINJECTIONROCEPHIN

DISC HOFFMANN LA ROCHE EQ 10GM BASEVIAL N 050585 005 Mar 15 2011 Current OBNOROCEPHIN W DEXTROSE IN PLASTIC CONTAINER

DISC HOFFMANN LA ROCHE EQ 10MG BASEML N 050624 001 Nov 18 2016 Current OBYESDISC EQ 20MG BASEML N 050624 002 Nov 18 2016 Current OBYESDISC EQ 40MG BASEML N 050624 003 Nov 18 2016 Current OBYESINJECTABLEINTRAMUSCULAR INTRAVENOUSROCEPHIN

DISC HOFFMANN LA ROCHE EQ 1GM BASEVIAL N 050585 003 Mar 15 2011 Current OBNODISC EQ 2GM BASEVIAL N 050585 004 Mar 15 2011 Current OBNODISC EQ 250MG BASEVIAL N 050585 001 Mar 15 2011 Current OBNODISC EQ 500MG BASEVIAL N 050585 002 Mar 15 2011 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 12 of 50

CEPHALEXINCAPSULEORALKEFLEX

DISC PRAGMA PHARMS LLC EQ 333MG BASE N 050405 004 Apr 12 2011 Current OBYESFOR SUSPENSIONORALCEPHALEXIN

DISC FACTA FARMA EQ 100MG BASEML A 062117 001 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML A 062117 002 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML A 062117 003 Mar 15 2016 Current OBYES

KEFLEXDISC PRAGMA PHARMS LLC EQ 100MG BASEML N 050406 003 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML N 050406 001 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML N 050406 002 Mar 15 2016 Current OBYES

CHENODIOLTABLETORALCHENIX

DISC SIGMA TAU 250MG N 018513 002 May 23 2007 Current OBYES

CHLOROTHIAZIDESUSPENSIONORALDIURIL

RX SALIX PHARMS 250MG5ML N 011870 001 May 23 2007 Current OBNOTABLETORALDIURIL

DISC OAK PHARMS AKORN 250MG N 011145 004 May 23 2007 Current OBYESDISC 500MG N 011145 002 May 23 2007 Current OBYES

CHLORPROMAZINESUPPOSITORYRECTALTHORAZINE

DISC GLAXOSMITHKLINE 25MG N 009149 024 Jun 15 2009 Current OBYESDISC 100MG N 009149 033 Jun 15 2009 Current OBYES

CHLORPROMAZINE HYDROCHLORIDECONCENTRATEORALTHORAZINE

DISC GLAXOSMITHKLINE 30MGML N 009149 032 Jun 15 2009 Current OBYESDISC 100MGML N 009149 043 Jun 15 2009 Current OBYESINJECTABLEINJECTIONTHORAZINE

DISC GLAXOSMITHKLINE 25MGML N 009149 011 Jun 15 2009 Current OBYESSYRUPORALTHORAZINE

DISC GLAXOSMITHKLINE 10MG5ML N 009149 022 Jun 15 2009 Current OBYESTABLETORALCHLORPROMAZINE HYDROCHLORIDE

DISC SANDOZ 10MG A 080439 001 Jan 21 2016 Current OBYESDISC 25MG A 080439 002 Jan 21 2016 Current OBYESDISC 50MG A 080439 003 Jan 21 2016 Current OBYESDISC 100MG A 080439 004 Jan 21 2016 Current OBYESDISC 200MG A 080439 005 Jan 21 2016 Current OBYES

THORAZINEDISC GLAXOSMITHKLINE 10MG N 009149 002 May 23 2007 Current OBYESDISC 25MG N 009149 007 May 23 2007 Current OBYESDISC 50MG N 009149 013 May 23 2007 Current OBYESDISC 100MG N 009149 018 May 23 2007 Current OBYESDISC 200MG N 009149 020 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 17 of 50

DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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December 2016 Page 21 of 50

TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

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2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

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See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

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December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

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December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

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December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 11: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 11 of 50

CEFIXIMEFOR SUSPENSIONORALSUPRAX

DISC LEDERLE 100MG5ML N 050622 001 Feb 18 2004 Current OBYESTABLETORALSUPRAX

DISC LEDERLE 200MG N 050621 001 Feb 18 2004 Current OBYESDISC 400MG N 050621 002 Feb 18 2004 Current OBYES

CEFMETAZOLE SODIUMINJECTABLEINJECTIONZEFAZONE

DISC PHARMACIA AND EQ 1GM BASEVIAL N 050637 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 2GM BASEVIAL N 050637 002 Mar 10 2014 Current OBYESZEFAZONE IN PLASTIC CONTAINER

DISC PHARMACIA AND EQ 20MG BASEML N 050683 001 Mar 10 2014 Current OBYESUPJOHN

DISC EQ 40MG BASEML N 050683 002 Mar 10 2014 Current OBYES

CEFOTETAN DISODIUMINJECTABLEINJECTIONCEFOTAN

RX TELIGENT PHARMA EQ 1GM BASEVIAL N 050588 001 Jun 07 2007 Current OBNOINC

RX EQ 2GM BASEVIAL N 050588 002 Jun 07 2007 Current OBNO

CEFOXITIN SODIUMINJECTABLEINJECTIONCEFOXITIN

DISC FRESENIUS KABI USA EQ 1GM BASEVIAL A 065012 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 065012 002 May 04 2016 Current OBYES

MEFOXINDISC MYLAN EQ 1GM BASEVIAL N 050517 001 Mar 11 2010 Current OBYES

INSTITUTIONALDISC EQ 2GM BASEVIAL N 050517 002 Mar 11 2010 Current OBYESDISC EQ 10GM BASEVIAL N 050517 003 Sep 06 2007 Current OBYES

CEFPODOXIME PROXETILFOR SUSPENSIONORALVANTIN

DISC PHARMACIA AND EQ 50MG BASE5ML N 050675 001 Jan 21 2016 Current OBYESUPJOHN

DISC EQ 100MG BASE5ML N 050675 002 Jan 21 2016 Current OBYES

CEFTRIAXONE SODIUMINJECTABLEINJECTIONROCEPHIN

DISC HOFFMANN LA ROCHE EQ 10GM BASEVIAL N 050585 005 Mar 15 2011 Current OBNOROCEPHIN W DEXTROSE IN PLASTIC CONTAINER

DISC HOFFMANN LA ROCHE EQ 10MG BASEML N 050624 001 Nov 18 2016 Current OBYESDISC EQ 20MG BASEML N 050624 002 Nov 18 2016 Current OBYESDISC EQ 40MG BASEML N 050624 003 Nov 18 2016 Current OBYESINJECTABLEINTRAMUSCULAR INTRAVENOUSROCEPHIN

DISC HOFFMANN LA ROCHE EQ 1GM BASEVIAL N 050585 003 Mar 15 2011 Current OBNODISC EQ 2GM BASEVIAL N 050585 004 Mar 15 2011 Current OBNODISC EQ 250MG BASEVIAL N 050585 001 Mar 15 2011 Current OBNODISC EQ 500MG BASEVIAL N 050585 002 Mar 15 2011 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 12 of 50

CEPHALEXINCAPSULEORALKEFLEX

DISC PRAGMA PHARMS LLC EQ 333MG BASE N 050405 004 Apr 12 2011 Current OBYESFOR SUSPENSIONORALCEPHALEXIN

DISC FACTA FARMA EQ 100MG BASEML A 062117 001 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML A 062117 002 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML A 062117 003 Mar 15 2016 Current OBYES

KEFLEXDISC PRAGMA PHARMS LLC EQ 100MG BASEML N 050406 003 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML N 050406 001 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML N 050406 002 Mar 15 2016 Current OBYES

CHENODIOLTABLETORALCHENIX

DISC SIGMA TAU 250MG N 018513 002 May 23 2007 Current OBYES

CHLOROTHIAZIDESUSPENSIONORALDIURIL

RX SALIX PHARMS 250MG5ML N 011870 001 May 23 2007 Current OBNOTABLETORALDIURIL

DISC OAK PHARMS AKORN 250MG N 011145 004 May 23 2007 Current OBYESDISC 500MG N 011145 002 May 23 2007 Current OBYES

CHLORPROMAZINESUPPOSITORYRECTALTHORAZINE

DISC GLAXOSMITHKLINE 25MG N 009149 024 Jun 15 2009 Current OBYESDISC 100MG N 009149 033 Jun 15 2009 Current OBYES

CHLORPROMAZINE HYDROCHLORIDECONCENTRATEORALTHORAZINE

DISC GLAXOSMITHKLINE 30MGML N 009149 032 Jun 15 2009 Current OBYESDISC 100MGML N 009149 043 Jun 15 2009 Current OBYESINJECTABLEINJECTIONTHORAZINE

DISC GLAXOSMITHKLINE 25MGML N 009149 011 Jun 15 2009 Current OBYESSYRUPORALTHORAZINE

DISC GLAXOSMITHKLINE 10MG5ML N 009149 022 Jun 15 2009 Current OBYESTABLETORALCHLORPROMAZINE HYDROCHLORIDE

DISC SANDOZ 10MG A 080439 001 Jan 21 2016 Current OBYESDISC 25MG A 080439 002 Jan 21 2016 Current OBYESDISC 50MG A 080439 003 Jan 21 2016 Current OBYESDISC 100MG A 080439 004 Jan 21 2016 Current OBYESDISC 200MG A 080439 005 Jan 21 2016 Current OBYES

THORAZINEDISC GLAXOSMITHKLINE 10MG N 009149 002 May 23 2007 Current OBYESDISC 25MG N 009149 007 May 23 2007 Current OBYESDISC 50MG N 009149 013 May 23 2007 Current OBYESDISC 100MG N 009149 018 May 23 2007 Current OBYESDISC 200MG N 009149 020 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 17 of 50

DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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December 2016 Page 21 of 50

TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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See List Footnote

December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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See List Footnote

December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 12: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 12 of 50

CEPHALEXINCAPSULEORALKEFLEX

DISC PRAGMA PHARMS LLC EQ 333MG BASE N 050405 004 Apr 12 2011 Current OBYESFOR SUSPENSIONORALCEPHALEXIN

DISC FACTA FARMA EQ 100MG BASEML A 062117 001 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML A 062117 002 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML A 062117 003 Mar 15 2016 Current OBYES

KEFLEXDISC PRAGMA PHARMS LLC EQ 100MG BASEML N 050406 003 Mar 15 2016 Current OBYESDISC EQ 125MG BASE5ML N 050406 001 Mar 15 2016 Current OBYESDISC EQ 250MG BASE5ML N 050406 002 Mar 15 2016 Current OBYES

CHENODIOLTABLETORALCHENIX

DISC SIGMA TAU 250MG N 018513 002 May 23 2007 Current OBYES

CHLOROTHIAZIDESUSPENSIONORALDIURIL

RX SALIX PHARMS 250MG5ML N 011870 001 May 23 2007 Current OBNOTABLETORALDIURIL

DISC OAK PHARMS AKORN 250MG N 011145 004 May 23 2007 Current OBYESDISC 500MG N 011145 002 May 23 2007 Current OBYES

CHLORPROMAZINESUPPOSITORYRECTALTHORAZINE

DISC GLAXOSMITHKLINE 25MG N 009149 024 Jun 15 2009 Current OBYESDISC 100MG N 009149 033 Jun 15 2009 Current OBYES

CHLORPROMAZINE HYDROCHLORIDECONCENTRATEORALTHORAZINE

DISC GLAXOSMITHKLINE 30MGML N 009149 032 Jun 15 2009 Current OBYESDISC 100MGML N 009149 043 Jun 15 2009 Current OBYESINJECTABLEINJECTIONTHORAZINE

DISC GLAXOSMITHKLINE 25MGML N 009149 011 Jun 15 2009 Current OBYESSYRUPORALTHORAZINE

DISC GLAXOSMITHKLINE 10MG5ML N 009149 022 Jun 15 2009 Current OBYESTABLETORALCHLORPROMAZINE HYDROCHLORIDE

DISC SANDOZ 10MG A 080439 001 Jan 21 2016 Current OBYESDISC 25MG A 080439 002 Jan 21 2016 Current OBYESDISC 50MG A 080439 003 Jan 21 2016 Current OBYESDISC 100MG A 080439 004 Jan 21 2016 Current OBYESDISC 200MG A 080439 005 Jan 21 2016 Current OBYES

THORAZINEDISC GLAXOSMITHKLINE 10MG N 009149 002 May 23 2007 Current OBYESDISC 25MG N 009149 007 May 23 2007 Current OBYESDISC 50MG N 009149 013 May 23 2007 Current OBYESDISC 100MG N 009149 018 May 23 2007 Current OBYESDISC 200MG N 009149 020 May 23 2007 Current OBYES

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December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

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December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

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December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

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December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

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DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

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December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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See List Footnote

December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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See List Footnote

December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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See List Footnote

December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 13: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 13 of 50

CHLORTHALIDONETABLETORALHYGROTON

DISC SANOFI AVENTIS US 25MG N 012283 004 Feb 18 2004 Current OBYESDISC 50MG N 012283 003 Feb 18 2004 Current OBYES

THALITONEDISC CASPER PHARMA LLC 15MG N 019574 001 Apr 25 2016 Current OBYES

CHLORTHALIDONE CLONIDINE HYDROCHLORIDETABLETORALCOMBIPRES

DISC BOEHRINGER

INGELHEIM

15MG01MG N 017503 001 Feb 18 2004 Current OBYES

DISC 15MG02MG N 017503 002 Feb 18 2004 Current OBYES

DISC 15MG03MG N 017503 003 Feb 18 2004 Current OBYES

CHLORZOXAZONETABLETORALPARAFLEX

DISC ORTHO MCNEIL PHARM 250MG N 011300 003 Oct 23 2013 Current OBYESPARAFON FORTE DSC

DISC JANSSEN R AND D 500MG N 011529 002 Jul 14 2016 Current OBYES

CHOLESTYRAMINEPOWDERORALQUESTRAN

DISC BRISTOL MYERS EQ 4GM RESINPACKET N 016640 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 016640 003 Mar 26 2013 Current OBYES

QUESTRAN LIGHTDISC BRISTOL MYERS EQ 4GM RESINPACKET N 019669 001 Mar 26 2013 Current OBYESDISC EQ 4GM RESINSCOOPFUL N 019669 003 Mar 26 2013 Current OBYES

CHYMOPAPAININJECTABLEINJECTIONCHYMODIACTIN

DISC CHART MEDCL 10000 UNITSVIAL N 018663 001 Jan 27 2003 Current OBYES

CIDOFOVIRINJECTABLEINJECTIONVISTIDE

DISC GILEAD SCIENCES EQ 75MG BASEML N 020638 001 Oct 30 2015 Current OBYESINC

CILOSTAZOLTABLETORALPLETAL

DISC OTSUKA 50MG N 020863 001 Nov 18 2016 Current OBYESDISC 100MG N 020863 002 Nov 18 2016 Current OBYES

CIMETIDINETABLETORALTAGAMET

DISC GLAXOSMITHKLINE 200MG N 017920 002 Jan 09 2015 Current OBYESDISC 300MG N 017920 003 Jan 09 2015 Current OBYESDISC 400MG N 017920 004 Jan 09 2015 Current OBYESDISC 800MG N 017920 005 Jan 09 2015 Current OBYES

CIMETIDINE HYDROCHLORIDEINJECTABLEINJECTIONTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE2ML N 017939 002 May 23 2007 Current OBYESTAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 09 IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 6MG BASEML N 019434 001 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

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DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

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DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

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See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 14: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 14 of 50

SOLUTIONORALTAGAMET

DISC GLAXOSMITHKLINE EQ 300MG BASE5ML N 017924 001 Mar 11 2010 Current OBYES

CITALOPRAM HYDROBROMIDESOLUTIONORALCELEXA

DISC FOREST LABS EQ 10MG BASE5ML N 021046 001 Aug 14 2014 Current OBYES

CLADRIBINEINJECTABLEINJECTIONLEUSTATIN

DISC JANSSEN PHARMS 1MGML N 020229 001 Aug 14 2014 Current OBYES

CLARITHROMYCINTABLET EXTENDED RELEASEORALBIAXIN XL

DISC ABBVIE 500MG N 050775 001 Aug 27 2015 Current OBYES

CLEMASTINE FUMARATESYRUPORALTAVIST

DISC NOVARTIS EQ 05MG BASE5ML N 018675 001 May 23 2007 Current OBYES

CLINDAMYCIN PALMITATE HYDROCHLORIDEFOR SOLUTIONORALCLEOCIN

DISC PHARMACIA AND EQ 75MG BASE5ML A 061827 001 Jan 21 2016 Current OBYESUPJOHN

CLOBETASOL PROPIONATECREAMTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019322 001 Oct 30 2015 Current OBYESTEMOVATE E

DISC FOUGERA PHARMS 005 N 020340 001 Oct 30 2015 Current OBYESGELTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 020337 001 Oct 30 2015 Current OBYESOINTMENTTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019323 001 Nov 18 2016 Current OBYESSOLUTIONTOPICALTEMOVATE

DISC FOUGERA PHARMS 005 N 019966 001 Jan 26 2015 Current OBYES

CLONAZEPAMTABLET ORALLY DISINTEGRATINGORALKLONOPIN RAPIDLY DISINTEGRATING

DISC ROCHE 0125MG N 020813 001 Aug 14 2014 Current OBYESDISC 025MG N 020813 002 Aug 14 2014 Current OBYESDISC 05MG N 020813 003 Aug 14 2014 Current OBYESDISC 1MG N 020813 004 Aug 14 2014 Current OBYESDISC 2MG N 020813 005 Aug 14 2014 Current OBYES

CLONIDINE HYDROCHLORIDETABLET EXTENDED RELEASEORALJENLOGA

DISC CONCORDIA PHARMS 01MG N 022331 001 Feb 13 2012 Current OBYESINC

DISC 02MG N 022331 002 Feb 13 2012 Current OBYESKAPVAY

DISC CONCORDIA PHARMS 02MG N 022331 004 Feb 13 2012 Current OBYESINC

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 17 of 50

DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 21 of 50

TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 15: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 15 of 50

CLOTRIMAZOLESOLUTIONTOPICALMYCELEX

DISC BAYER HLTHCARE 1 N 018181 001 Aug 19 2013 Current OBYESTROCHELOZENGEORALMYCELEX

DISC BAYER HLTHCARE 10MG N 018713 001 Aug 19 2013 Current OBYES

CODEINE PHOSPHATE PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC W CODEINE

DISC ANI PHARMS 10MG5ML5MG5ML625MG5ML N 008306 005 Apr 28 2008 Current OBYES

CODEINE PHOSPHATE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN W CODEINE

DISC ANI PHARMS 10MG5ML625MG5ML N 008306 004 Apr 28 2008 Current OBYES

COLCHICINE PROBENECIDTABLETORALCOLBENEMID

DISC MERCK 05MG500MG N 012383 001 Aug 06 2003 Current OBYES

CROMOLYN SODIUMCAPSULEINHALATIONINTAL

DISC SANOFI AVENTIS US 20MG N 016990 001 Oct 23 2013 Current OBYESSOLUTIONDROPSOPHTHALMICOPTICROM

DISC ALLERGAN 4 N 018155 001 Jan 09 2015 Current OBYES

CYANOCOBALAMININJECTABLEINJECTIONRUBRAMIN PC

DISC BRISTOL MYERS 1MGML N 006799 004 Dec 19 2008 Current OBYESSQUIBB

DISC 1MGML N 006799 010 Dec 19 2008 Current OBYES

CYCLOBENZAPRINE HYDROCHLORIDETABLETORALFLEXERIL

DISC JANSSEN RES AND 5MG N 017821 001 Mar 25 2013 Current OBYESDEV

DISC 10MG N 017821 002 Mar 25 2013 Current OBYES

CYCLOPHOSPHAMIDETABLETORALCYTOXAN

DISC BAXTER HLTHCARE 25MG N 012141 002 Mar 11 2010 Current OBYESDISC 50MG N 012141 001 Mar 11 2010 Current OBYES

CYCLOSPORINECAPSULEORALNEORAL

DISC NOVARTIS 50MG N 050715 003 Jun 20 2001 Current OBYES

CYPROHEPTADINE HYDROCHLORIDESYRUPORALCYPROHEPTADINE HYDROCHLORIDE

DISC ACTAVIS MID 2MG5ML A 086833 001 Nov 18 2016 Current OBYESATLANTICPERIACTIN

DISC MERCK 2MG5ML N 013220 002 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

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DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

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DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

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December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 16: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 16 of 50

TABLETORALPERIACTIN

DISC MERCK 4MG N 012649 001 May 28 2003 Current OBYES

CYSTEINE HYDROCHLORIDEINJECTABLEINJECTIONCYSTEINE HYDROCHLORIDE

DISC HOSPIRA 725 N 019523 001 Jun 04 2010 Current OBYES

CYTARABINEINJECTABLEINJECTIONCYTARABINE

DISC TEVA PARENTERAL 1GMVIAL N 016793 003 Jan 21 2016 Current OBYESDISC 2GMVIAL N 016793 004 Jan 21 2016 Current OBYESDISC 100MGVIAL N 016793 001 Jan 21 2016 Current OBYESDISC 500MGVIAL N 016793 002 Jan 21 2016 Current OBYES

DAPIPRAZOLE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICDAPIPRAZOLE HYDROCHLORIDE

DISC FERA PHARMS 05 N 019849 001 May 13 2013 Current OBYES

DARUNAVIR ETHANOLATETABLETORALPREZISTA

DISC JANSSEN PRODS EQ 300MG BASE N 021976 001 Jan 18 2012 Current OBYESDISC EQ 400MG BASE N 021976 003 Apr 02 2014 Current OBYES

DESMOPRESSIN ACETATESPRAY METEREDNASALDDAVP

DISC FERRING PHARMS INC 001MGSPRAY N 017922 002 Nov 21 1997 Current OBYES

DESOGESTREL ETHINYL ESTRADIOLTABLETORAL-28MIRCETTE

DISC TEVA BRANDED PHARM 015MGNA002MG001MG002MG N 020713 001 Jan 09 2015 Current OBYES001MG

DESOXIMETASONECREAMTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 017856 001 Oct 31 2014 Current OBYESTOPICORT LP

DISC TARO PHARMS NORTH 005 N 018309 001 Apr 04 2016 Current OBYESGELTOPICALTOPICORT

DISC TARO PHARMS NORTH 005 N 018586 001 Nov 18 2016 Current OBYESOINTMENTTOPICALTOPICORT

DISC TARO PHARMS NORTH 025 N 018763 001 Sep 27 2012 Current OBYES

DEXAMETHASONEAEROSOLTOPICALAEROSEB-DEX

DISC ALLERGAN HERBERT 001 A 083296 002 Feb 09 2011 Current OBYESDECASPRAY

DISC MERCK 004 N 012731 002 Feb 09 2011 Current OBYESTABLETORALDECADRON

DISC MERCK 025MG N 011664 004 May 23 2007 Current OBYESDISC 05MG N 011664 001 May 14 2009 Current OBYESDISC 075MG N 011664 002 May 14 2009 Current OBYESDISC 15MG N 011664 003 Dec 28 2005 Current OBYESDISC 4MG N 011664 005 May 23 2007 Current OBYESDISC 6MG N 011664 006 May 23 2007 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 17 of 50

DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 21 of 50

TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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See List Footnote

December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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See List Footnote

December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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See List Footnote

December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 17: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 17 of 50

DEXAMETHASONE ACETATEINJECTABLEINJECTIONDECADRON-LA

DISC MERCK EQ 8MG BASEML N 016675 001 Aug 24 2004 Current OBYES

DEXAMETHASONE SODIUM PHOSPHATEINJECTABLEINJECTIONDECADRON

DISC MERCK EQ 4MG PHOSPHATEML N 012071 002 Oct 01 2003 Current OBYESDISC EQ 24MG PHOSPHATEML N 012071 004 Oct 01 2003 Current OBYES

HEXADROLDISC ORGANON USA INC EQ 4MG PHOSPHATEML N 014694 002 Oct 01 2003 Current OBYESDISC EQ 10MG PHOSPHATEML N 014694 003 Oct 01 2003 Current OBYES

DEXTROAMPHETAMINE SULFATEELIXIRORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG5ML A 083902 001 Aug 07 2007 Current OBYESTABLETORALDEXEDRINE

DISC GLAXOSMITHKLINE 5MG A 084935 001 Mar 02 2011 Current OBNODEXTROAMPHETAMINE SULFATE

DISC LANNETT 15MG A 085652 001 Oct 18 2002 Current OBNODEXTROSTAT

DISC SHIRE 5MG A 084051 001 Mar 02 2011 Current OBYESDISC 10MG A 084051 002 Mar 02 2011 Current OBYES

DEXTROMETHORPHAN HYDROBROMIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPROMETH W DEXTROMETHORPHAN

RX G AND W LABS INC 15MG5ML625MG5ML A 088762 001 Jul 20 2015 Current OBYESPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

DISC ANI PHARMS 15MG5ML625MG5ML N 011265 002 Apr 28 2008 Current OBYES

DIAZEPAMGELRECTALDIASTAT

DISC VALEANT PHARMS 5MGML (5MGML) N 020648 002 Aug 18 2010 Current OBYESNORTH

DISC 10MG2ML (5MGML) N 020648 003 Aug 18 2010 Current OBYESDISC 15MG3ML (5MGML) N 020648 004 Aug 18 2010 Current OBYESDISC 20MG4ML (5MGML) N 020648 005 Aug 18 2010 Current OBYESINJECTABLEINJECTIONDIAZEPAM

DISC US ARMY 5MGML N 020124 001 Dec 30 2002 Current OBYESVALIUM

DISC ROCHE 5MGML N 016087 001 Sep 06 2016 Current OBYES

DICHLORPHENAMIDETABLETORALDARANIDE

DISC STRONGBRIDGE US 50MG N 011366 001 Aug 06 2007 Current OBYES

DICLOFENAC POTASSIUMTABLETORALCATAFLAM

DISC NOVARTIS 25MG N 020142 001 Nov 18 2003 Current OBYES

DICLOFENAC SODIUMTABLET DELAYED RELEASEORALVOLTAREN

DISC NOVARTIS 25MG N 019201 001 May 23 2007 Current OBYESDISC 50MG N 019201 002 May 23 2007 Current OBYESDISC 75MG N 019201 003 Jul 22 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

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December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

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2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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See List Footnote

December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 18: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 18 of 50

DICYCLOMINE HYDROCHLORIDE

SYRUPORAL

BENTYL

DISC APTALIS PHARMA US 10MG5ML N 007961 002 Aug 08 2016 Current OBYES

DIDANOSINE

TABLET CHEWABLEORAL

VIDEX

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG

50MG

N 020154 002 Jun 15 2009 Current OBYES

N 020154 003 Jun 15 2009 Current OBYES

DISC 100MG N 020154 004 Jun 15 2009 Current OBYES

DISC 150MG N 020154 005 Jun 15 2009 Current OBYES

DISC 200MG N 020154 006 Jun 15 2009 Current OBYES

DIFLUNISAL

TABLETORAL

DOLOBID

DISC MERCK 250MG N 018445 001 Jun 15 2009 Current OBYES

DISC 500MG N 018445 002 Jun 15 2009 Current OBYES

DILTIAZEM HYDROCHLORIDE

CAPSULE EXTENDED RELEASEORAL

CARDIZEM SR

BIOVAILDISC

DISC

DISC

DISC

DILACOR XR

60MG

90MG

120MG

180MG

N 019471 001 May 23 2007 Current OBYES

N 019471 002 May 23 2007 Current OBYES

N 019471 003 May 23 2007 Current OBYES

N 019471 004 May 23 2007 Current OBYES

DISC ALLERGAN SALES LLC 120MG N 020092 001 Jul 20 2015 Current OBYES

DISC 180MG N 020092 002 Jul 20 2015 Current OBYES

DISC 240MG N 020092 003 Jul 20 2015 Current OBYES

INJECTABLEINJECTION

CARDIZEM

DISC

DISC

BIOVAIL LABS INTL 5MGML

25MGVIAL

N 020027 001 Jun 15 2009 Current OBYES

N 020027 003 Jun 15 2009 Current OBYES

DIPHENHYDRAMINE HYDROCHLORIDE

INJECTABLEINJECTION

BENADRYL

MCNEIL CONS 50MGMLDISC

BENADRYL PRESERVATIVE FREE

N 006146 002 Mar 25 2013 Current OBYES

DISC MCNEIL CONS 50MGML N 009486 001 Mar 25 2013 Current OBYES

DIPYRIDAMOLE

INJECTABLEINJECTION

IV PERSANTINE

DISC BOEHRINGER

INGELHEIM

5MGML N 019817 001 May 23 2007 Current OBYES

DISULFIRAM

TABLETORAL

ANTABUSE

DISC

DISC

TEVA WOMENS 250MG

500MG

N 007883 003 Sep 26 2001 Current OBYES

N 007883 002 Sep 26 2001 Current OBYES

DOCETAXEL

INJECTABLEINJECTION

TAXOTERE

DISC SANOFI AVENTIS US 40MGML N 020449 001 Nov 28 2011 Current OBYES

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December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

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December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

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TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

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December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

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December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

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December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

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December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 19: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 19 of 50

DOXEPIN HYDROCHLORIDECAPSULEORALSINEQUAN

DISC PFIZER EQ 10MG BASE N 016798 003 Jul 22 2011 Current OBYESDISC EQ 25MG BASE N 016798 001 Jul 22 2011 Current OBYESDISC EQ 50MG BASE N 016798 002 Jul 22 2011 Current OBYESDISC EQ 75MG BASE N 016798 006 Jul 22 2011 Current OBYESDISC EQ 100MG BASE N 016798 005 Jul 22 2011 Current OBYESDISC EQ 150MG BASE N 016798 007 Jul 22 2011 Current OBYESCONCENTRATEORALSINEQUAN

DISC PFIZER EQ 10MG BASEML N 017516 001 Jul 22 2011 Current OBYES

DOXYCYCLINE HYCLATECAPSULE DELAYED RELEASEORALDORYX

DISC MAYNE PHARMA INTL EQ 75MG BASE N 050582 002 Dec 19 2008 Current OBNODISC EQ 100MG BASE N 050582 001 Dec 19 2008 Current OBNOCAPSULEORALVIBRAMYCIN

DISC PFIZER EQ 50MG BASE N 050007 001 May 04 2016 Current OBYESINJECTABLEINJECTIONVIBRAMYCIN

DISC PFIZER EQ 100MG BASEVIAL N 050442 002 Nov 18 2016 Current OBYESDISC EQ 200MG BASEVIAL N 050442 001 Nov 18 2016 Current OBYESTABLETORALPERIOSTAT

DISC COLLAGENEX EQ 20MG BASE N 050744 001 May 16 2005 Current OBYESDISC GALDERMA LABS LP EQ 20MG BASE N 050783 001 Jan 26 2015 Current OBYES

VIBRA-TABSDISC PFIZER EQ 100MG BASE N 050533 001 Aug 14 2014 Current OBYES

DOXYLAMINE SUCCINATE PYRIDOXINE HYDROCHLORIDETABLET EXTENDED RELEASEORALBENDECTIN

DISC SANOFI AVENTIS US 10MG10MG N 010598 002 Jul 28 1999 Current OBYES

DYCLONINE HYDROCHLORIDESOLUTIONTOPICALDYCLONE

DISC ASTRAZENECA 05 N 009925 002 Nov 16 2004 Current OBYESDISC 1 N 009925 001 Nov 16 2004 Current OBYES

EDROPHONIUM CHLORIDEINJECTABLEINJECTIONTENSILON

DISC TELIGENT PHARMA 10MGML N 007959 001 Oct 30 2015 Current OBYESINCTENSILON PRESERVATIVE FREE

DISC TELIGENT PHARMA 10MGML N 007959 002 Oct 30 2015 Current OBYESINC

EFAVIRENZCAPSULEORALSUSTIVA

DISC BRISTOL MYERS 100MG N 020972 002 Jun 15 2012 Current OBYESSQUIBB

TABLETORALSUSTIVA

DISC BRISTOL MYERS 300MG N 021360 001 Feb 02 2007 Current OBYESSQUIBB

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 21 of 50

TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

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December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

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December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 20: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 20 of 50

ENOXAPARIN SODIUMINJECTABLESUBCUTANEOUSLOVENOX (PRESERVATIVE FREE)

DISC SANOFI AVENTIS US 90MG06ML (150MGML) N 020164 006 Mar 08 2004 Current OBYES

EPINEPHRINE BITARTRATE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML1 N 017751 006 Mar 13 2012 Current OBYESDISC 0005MGML15 N 017751 007 Mar 13 2012 Current OBYESDISC DENTSPLY PHARM 0005MGML15 N 021384 001 Mar 13 2012 Current OBYES

EPINEPHRINE ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 0005MGML05 N 017751 004 Mar 13 2012 Current OBYES

ERYTHROMYCINSOLUTIONTOPICALSTATICIN

DISC WESTWOOD SQUIBB 15 N 050526 001 Jan 21 2016 Current OBYEST-STAT

DISC WESTWOOD SQUIBB 2 A 062436 001 Jan 21 2016 Current OBYES

ERYTHROMYCIN ETHYLSUCCINATESUSPENSIONORALEES 200

DISC ARBOR PHARMS LLC EQ 200MG BASE5ML A 061639 001 May 04 2016 Current OBYESEES 400

DISC ARBOR PHARMS LLC EQ 400MG BASE5ML A 061639 002 May 04 2016 Current OBYES

ESMOLOL HYDROCHLORIDEINJECTABLEINJECTIONBREVIBLOC

RX BAXTER HLTHCARE 10MGML N 019386 006 Aug 04 2004 Current OBNO

ESTAZOLAMTABLETORALPROSOM

DISC ABBOTT 1MG N 019080 001 May 14 2009 Current OBYESDISC 2MG N 019080 002 May 14 2009 Current OBYES

ESTRADIOLTABLETORALESTRACE

DISC BRISTOL MYERS 05MG A 081295 001 Nov 12 2013 Current OBNOSQUIBB

DISC 1MG A 084499 001 Nov 12 2013 Current OBNODISC 2MG A 084500 001 Nov 12 2013 Current OBNOTABLETVAGINALVAGIFEM

DISC NOVO NORDISK INC 25MCG N 020908 001 May 22 2015 Current OBYES

ESTRADIOL NORGESTIMATETABLETORALPREFEST

DISC TEVA WOMENS 1MG1MG1MG1MGNA009MG N 021040 001 Jan 26 2015 Current OBYES

ETHINYL ESTRADIOL ETHYNODIOL DIACETATETABLETORAL-21DEMULEN 135-21

DISC GD SEARLE LLC 0035MG1MG N 018168 001 Dec 05 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 21 of 50

TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

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December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

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December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 21: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 21 of 50

TABLETORAL-28DEMULEN 135-28

DISC GD SEARLE LLC 0035MG1MG N 018160 001 Dec 05 2011 Current OBYESDEMULEN 150-28

DISC GD SEARLE LLC 005MG1MG N 016936 001 Dec 05 2011 Current OBYES

ETHINYL ESTRADIOL LEVONORGESTRELTABLETORALLYBREL

DISC WYETH PHARMS INC 002MG009MG N 021864 001 Oct 31 2014 Current OBYESTABLETORAL-21ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 001 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 001 Mar 11 2010 Current OBYESTRIPHASIL-21

DISC WYETH PHARMS 003MG003MG004MG005MG00 N 019192 001 Dec 05 2011 Current OBYES75MG0125MG

TABLETORAL-28ALESSE

DISC WYETH PHARMS 002MG01MG N 020683 002 Mar 11 2010 Current OBYESLEVLITE

DISC BAYER HLTHCARE 002MG01MG N 020860 002 Mar 11 2010 Current OBYESNORDETTE-28

DISC TEVA BRANDED PHARM 003MG015MG N 018782 001 Dec 04 2015 Current OBYESTRIPHASIL-28

DISC WYETH PHARMS INC 003MG003MG004MG005MG00 N 019190 001 Dec 05 2011 Current OBYES75MG0125MG

ETHINYL ESTRADIOL NORELGESTROMINFILM EXTENDED RELEASETRANSDERMALORTHO EVRA

DISC JANSSEN PHARMS 0035MG24HR015MG24HR N 021180 001 Sep 29 2015 Current OBYES

ETHINYL ESTRADIOL NORETHINDRONETABLETORAL-21ORTHO-NOVUM 1011-21

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 001 Aug 10 2010 Current OBYESJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 018127 001 Apr 04 2016 Current OBYESTABLETORAL-28ORTHO-NOVUM 1011-28

DISC ORTHO MCNEIL 0035MG0035MG05MG1MG N 018354 002 Aug 10 2010 Current OBNOJANSSENOVCON-35

DISC WARNER CHILCOTT 0035MG04MG N 017716 001 Dec 04 2015 Current OBYESLLC

ETHINYL ESTRADIOL NORETHINDRONE ACETATETABLETORALFEMHRT

DISC APIL 0005MG1MG N 021065 002 Aug 19 2013 Current OBYESLOESTRIN 24 FE

RX APIL 002MG1MG N 021871 001 Jul 20 2015 Current OBNOTABLETORAL-21ESTROSTEP 21

DISC APIL 002MG0035MG003MG1MG1MG1 N 020130 001 May 23 2007 Current OBYESMG

ETIDOCAINE HYDROCHLORIDEINJECTABLEINJECTIONDURANEST

DISC ASTRAZENECA 05 N 017751 003 Mar 13 2012 Current OBYESDISC 1 N 017751 005 Mar 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

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December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

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December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 22: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 22 of 50

ETODOLACCAPSULEORALLODINE

DISC WYETH PHARMS INC 200MG N 018922 002 May 23 2007 Current OBYESTABLET EXTENDED RELEASEORALLODINE XL

DISC WYETH PHARMS INC 600MG N 020584 002 May 23 2007 Current OBYESTABLETORALLODINE

DISC WYETH PHARMS INC 400MG N 018922 004 May 23 2007 Current OBYESDISC 500MG N 018922 005 May 23 2007 Current OBYES

ETOPOSIDEINJECTABLEINJECTIONVEPESID

DISC CORDEN PHARMA 20MGML N 018768 001 Mar 02 2011 Current OBYES

EVANS BLUEINJECTABLEINJECTIONEVANS BLUE

DISC PARKE DAVIS 05 N 008041 001 Nov 15 1996 Current OBYES

FAMOTIDINEINJECTABLEINJECTIONPEPCID

DISC MERCK 10MGML N 019510 001 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE

DISC MERCK 10MGML N 019510 004 Aug 19 2013 Current OBYESPEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER

DISC MERCK SHARP DOHME 04MGML N 020249 001 Aug 19 2013 Current OBYES

FELODIPINETABLET EXTENDED RELEASEORALPLENDIL

DISC ASTRAZENECA 25MG N 019834 004 Mar 15 2016 Current OBYESDISC 5MG N 019834 001 Mar 15 2016 Current OBYESDISC 10MG N 019834 002 Mar 15 2016 Current OBYES

FENOFIBRATECAPSULEORALTRICOR (MICRONIZED)

DISC ABBVIE 67MG N 019304 002 Oct 01 2003 Current OBYESDISC 134MG N 019304 003 Oct 01 2003 Current OBYESDISC 200MG N 019304 004 Oct 01 2003 Current OBYESTABLETORALTRICOR

DISC ABBOTT 54MG N 021203 001 Sep 06 2007 Current OBYESDISC 160MG N 021203 003 Sep 06 2007 Current OBYES

FENTANYL CITRATETABLETBUCCAL SUBLINGUALFENTORA

DISC CEPHALON EQ 03MG BASE N 021947 006 Apr 11 2011 Current OBYES

FLECAINIDE ACETATETABLETORALTAMBOCOR

RX CNTY LINE PHARMS 50MG N 018830 004 Nov 12 2013 Current OBNORX 100MG N 018830 001 Nov 12 2013 Current OBNORX 150MG N 018830 003 Nov 12 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

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December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

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See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 23: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 23 of 50

FLOXURIDINEINJECTABLEINJECTIONFUDR

DISC HOSPIRA 500MGVIAL N 016929 001 May 14 2009 Current OBYES

FLUDARABINE PHOSPHATEINJECTABLEINJECTIONFLUDARA

DISC GENZYME CORP 50MGVIAL N 020038 001 Sep 27 2012 Current OBYES

FLUDEOXYGLUCOSE F-18INJECTABLEINJECTIONFLUDEOXYGLUCOSE F18

DISC DOWNSTATE CLINCL 4-40mCiML N 020306 001 Oct 01 2008 Current OBYESDISC 4-90mCiML N 020306 002 Oct 01 2008 Current OBYESINJECTABLEINTRAVENOUSFLUDEOXYGLUCOSE F18

DISC WEILL MEDCL COLL 10-100mCiML N 021768 001 Jan 09 2015 Current OBYES

FLUDROCORTISONE ACETATETABLETORALFLORINEF

DISC CASPER PHARMA LLC 01MG N 010060 001 Dec 19 2008 Current OBYES

FLUMAZENILINJECTABLEINJECTIONROMAZICON

DISC HOFFMANN LA ROCHE 1MG10ML (01MGML) N 020073 001 Aug 14 2014 Current OBYESDISC 05MG5ML (01MGML) N 020073 002 Aug 14 2014 Current OBYES

FLUOCINONIDECREAMTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 016908 002 Aug 19 2013 Current OBNOLIDEX-E

DISC CNTY LINE PHARMS 005 N 016908 003 Aug 19 2013 Current OBNOGELTOPICALLIDEX

DISC CNTY LINE PHARMS 005 N 017373 001 Aug 14 2014 Current OBYESOINTMENTTOPICALLIDEX

RX CNTY LINE PHARMS 005 N 016909 002 Aug 14 2014 Current OBYES

FLUORESCEIN SODIUMINJECTABLEINJECTIONFUNDUSCEIN-25

DISC NOVARTIS 25 N 017869 001 Apr 18 2012 Current OBYES

FLUOROURACILINJECTABLEINJECTIONFLUOROURACIL

DISC SPECTRUM PHARMS 500MG10ML (50MGML) N 012209 001 Nov 18 2016 Current OBYES

FLUOXETINE HYDROCHLORIDECAPSULEORALSARAFEM

DISC ELI LILLY AND CO EQ 10MG BASE N 018936 007 Jul 20 2015 Current OBYESDISC EQ 20MG BASE N 018936 008 Jul 20 2015 Current OBYESSOLUTIONORALPROZAC

DISC LILLY EQ 20MG BASE5ML N 020101 001 Mar 11 2010 Current OBYESTABLETORALPROZAC

DISC LILLY EQ 10MG BASE N 020974 001 Oct 01 2008 Current OBYESDISC EQ 20MG BASE N 020974 002 Jun 21 2000 Current OBYES

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See List Footnote

December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

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See List Footnote

December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

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See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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See List Footnote

December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 24: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 24 of 50

FLUPHENAZINE DECANOATE

INJECTABLEINJECTION

PROLIXIN DECANOATE

DISC BRISTOL MYERS

SQUIBB

25MGML N 016727 001 May 04 2016 Current OBYES

FLURANDRENOLIDE

OINTMENTTOPICAL

CORDRAN

DISC AQUA PHARMS 0025 N 012806 004 Jun 11 2013 Current OBYES

RX 005 N 012806 001 Jun 11 2013 Current OBNO

FLUTICASONE PROPIONATE

CREAMTOPICAL

CUTIVATE

DISC FOUGERA PHARMS 005 N 019958 001 Jan 09 2015 Current OBYES

FLUVOXAMINE MALEATE

TABLETORAL

LUVOX

DISC

DISC

DISC

DISC

SOLVAY 25MG

50MG

100MG

150MG

N 020243 001 Sep 03 2003 Current OBYES

N 020243 002 Sep 03 2003 Current OBYES

N 020243 003 Sep 03 2003 Current OBYES

N 020243 004 Sep 03 2003 Current OBYES

FOSAPREPITANT DIMEGLUMINE

POWDERINTRAVENOUS

EMEND

DISC MERCK AND CO INC EQ 115MG BASEVIAL N 022023 001 Feb 18 2014 Current OBYES

FOSINOPRIL SODIUM

TABLETORAL

MONOPRIL

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG

20MG

N 019915 002 Nov 18 2016 Current OBYES

N 019915 003 Nov 18 2016 Current OBYES

DISC 40MG N 019915 004 Nov 18 2016 Current OBYES

FOSINOPRIL SODIUM HYDROCHLOROTHIAZIDE

TABLETORAL

MONOPRIL-HCT

DISC

DISC

BRISTOL MYERS

SQUIBB

10MG125MG

20MG125MG

N 020286 002 Mar 11 2010 Current OBYES

N 020286 001 Mar 11 2010 Current OBYES

FOSPHENYTOIN SODIUM

INJECTABLEINJECTION

CEREBYX

RX PARKE DAVIS EQ 50MG PHENYTOIN NAML N 020450 001 Mar 02 2011 Current OBNO

FUROSEMIDE

INJECTABLEINJECTION

FUROSEMIDE

LUITPOLDDISC

LASIX

10MGML N 018579 001 Sep 06 2016 Current OBYES

SANOFI AVENTIS USDISC 10MGML N 016363 001 May 23 2007 Current OBYES

GALLIUM NITRATE

INJECTABLEINJECTION

GANITE

DISC CHAPTER 7 TRUSTEE 25MGML N 019961 002 Feb 18 2014 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

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December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

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December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

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December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

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December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 25: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 25 of 50

GANCICLOVIR

CAPSULEORAL

CYTOVENE

DISC

DISC

ROCHE PALO 250MG

500MG

N 020460 001 Apr 28 2008 Current OBYES

N 020460 002 Apr 28 2008 Current OBYES

GANCICLOVIR SODIUM

INJECTABLEINJECTION

CYTOVENE

RX ROCHE PALO EQ 500MG BASEVIAL N 019661 001 Jun 15 2009 Current OBNO

GENTAMICIN SULFATE

CREAMTOPICAL

GARAMYCIN

DISC SCHERING EQ 01 BASE A 060462 001 Feb 18 2004 Current OBYES

INJECTABLEINJECTION

GARAMYCIN

SCHERINGDISC

DISC

DISC

INJECTABLEINTRATHECAL

GARAMYCIN

EQ 1MG BASEML

EQ 10MG BASEML

EQ 40MG BASEML

A 061716 002 Aug 08 2016 Current OBYES

A 061739 001 Aug 08 2016 Current OBYES

A 061716 001 Aug 08 2016 Current OBYES

SCHERINGDISC

OINTMENTTOPICAL

GARAMYCIN

EQ 2MG BASEML N 050505 001 Aug 08 2016 Current OBYES

SCHERINGDISC EQ 01 BASE A 060463 001 Nov 18 2016 Current OBYES

SOLUTIONDROPSOPHTHALMIC

GARAMYCIN

DISC SCHERING EQ 03 BASE N 050039 002 Feb 18 2014 Current OBYES

GLIMEPIRIDE ROSIGLITAZONE MALEATE

TABLETORAL

AVANDARYL

DISC SB PHARMCO 1MG4MG N 021700 001 Oct 30 2015 Current OBYES

DISC 2MG4MG N 021700 002 Oct 30 2015 Current OBYES

DISC 2MG8MG N 021700 004 Oct 30 2015 Current OBYES

DISC 4MG4MG N 021700 003 Oct 30 2015 Current OBYES

DISC 4MG8MG N 021700 005 Oct 30 2015 Current OBYES

GLIPIZIDE METFORMIN HYDROCHLORIDE

TABLETORAL

METAGLIP

DISC

DISC

BRISTOL MYERS

SQUIBB

25MG250MG

25MG500MG

N 021460 001 Nov 18 2016 Current OBYES

N 021460 002 Nov 18 2016 Current OBYES

DISC 5MG500MG N 021460 003 Nov 18 2016 Current OBYES

GLUCAGON HYDROCHLORIDE

INJECTABLEINJECTION

GLUCAGON

DISC

DISC

LILLY EQ 1MG BASEVIAL

EQ 10MG BASEVIAL

N 012122 001 Sep 09 2015 Current OBYES

N 012122 002 Sep 09 2015 Current OBYES

GLYBURIDE

TABLETORAL

GLYNASE

DISC PHARMACIA AND

UPJOHN

45MG N 020051 003 May 21 1996 Current OBYES

MICRONASE

DISC PHARMACIA AND

UPJOHN

125MG N 017498 001 Mar 11 2010 Current OBYES

DISC 5MG N 017498 003 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 26: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 26 of 50

GLYBURIDE METFORMIN HYDROCHLORIDETABLETORALGLUCOVANCE

DISC BRISTOL MYERS 125MG250MG N 021178 001 Jan 21 2016 Current OBYESSQUIBB

GLYCOPYRROLATEINJECTABLEINJECTIONROBINUL

DISC WEST-WARD PHARMS 02MGML N 017558 001 Sep 06 2016 Current OBYESINT

GRANISETRON HYDROCHLORIDEINJECTABLEINJECTIONKYTRIL

DISC ROCHE EQ 01MG BASEML (EQ 01MG N 020239 003 Oct 31 2014 Current OBYESBASEML)

DISC EQ 1MG BASEML (EQ 1MG BASEML) N 020239 004 Oct 31 2014 Current OBYESDISC EQ 3MG BASEML N 020239 001 Oct 31 2014 Current OBYESDISC EQ 4MG BASE4ML (EQ 1MG N 020239 002 Oct 31 2014 Current OBYES

BASEML)SOLUTIONORALKYTRIL

DISC ROCHE EQ 2MG BASE10ML N 021238 001 Jun 15 2009 Current OBYESTABLETORALKYTRIL

DISC ROCHE EQ 1MG BASE N 020305 001 Dec 28 2015 Current OBYESDISC EQ 2MG BASE N 020305 002 Dec 28 2015 Current OBYES

GRISEOFULVIN MICROCRYSTALLINESUSPENSIONORALGRIFULVIN V

DISC JOHNSON AND 125MG5ML N 050448 001 Jul 20 2015 Current OBYESJOHNSON

TABLETORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 250MG A 062279 002 May 01 2012 Current OBYES

GRISEOFULVIN MICROSIZESUSPENSIONORALGRIFULVIN V

DISC VALEANT LUXEMBOURG 125MG5ML A 062483 001 Jul 20 2015 Current OBYES

HALOPERIDOLTABLETORALHALDOL

DISC ORTHO MCNEIL 05MG N 015921 001 Aug 06 2003 Current OBYESDISC 1MG N 015921 002 Aug 06 2003 Current OBYESDISC 2MG N 015921 003 Aug 06 2003 Current OBYESDISC 5MG N 015921 004 Aug 06 2003 Current OBYESDISC 10MG N 015921 005 Aug 06 2003 Current OBYESDISC 20MG N 015921 006 Aug 06 2003 Current OBYES

HOMATROPINE METHYLBROMIDE HYDROCODONE BITARTRATESYRUPORALHYCODAN

DISC ENDO PHARMS 15MG5ML5MG5ML N 005213 002 Dec 30 2011 Current OBYESTABLETORALHYCODAN

DISC ENDO PHARMS 15MG5MG N 005213 001 Dec 30 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

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December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

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December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

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December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

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TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

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December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 27: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

2016

N 006343 002 Nov 06 2003N 006343 006 Nov 06 2003N 006343 005 Nov 06 2003

N 008303 003 Jun 06 2016

N 008303 004 Jun 06 2016N 008303 001 Jun 06 2016N 008303 002 Jun 06 2016N 008303 005 Jun 06 2016

N 011835 003 Aug 06 2003N 011835 006 Aug 06 2003N 011835 007 Aug 06 2003

N 020758 001 Jan 11 2012N 020758 004 Jan 11 2012

N 019778 003 Nov 18 2016N 019778 001 Nov 18 2016N 019778 002 Dec 19 2008

N 018303 003 Aug 10 2010

N 018031 001 May 04 2016

N 018031 002 May 04 2016

N 008917 001 May 15 1996

N 017950 001 Sep 27 2012

N 018726 001 Nov 12 2013

Page 27 of 50

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

December

HYALURONIDASEINJECTABLEINJECTIONWYDASE

DISC BAXTER HLTHCARE 150 UNITSMLDISC 150 UNITSVIALDISC 1500 UNITSVIAL

HYDRALAZINE HYDROCHLORIDEINJECTABLEINJECTIONAPRESOLINE

DISC NOVARTISTABLETORALAPRESOLINE

DISC NOVARTISDISCDISCDISC

HYDROCHLOROTHIAZIDETABLETORALHYDRODIURIL

DISC MERCKDISCDISC

HYDROCHLOROTHIAZIDE IRBESARTANTABLETORALAVALIDE

DISC SANOFI AVENTIS US 125MG75MGDISC 25MG300MG

HYDROCHLOROTHIAZIDE LISINOPRILTABLETORALPRINZIDE

DISC MERCKDISCDISC

125MG10MG125MG20MG25MG20MG

TABLETORALINDERIDE-4025

DISC WYETH PHARMS INCINDERIDE-8025

DISC WYETH PHARMS INC

HYDROCORTISONE ACETATEOINTMENTTOPICALCORTEF ACETATE

DISC PHARMACIA ANDUPJOHN

HYDROCORTISONE VALERATECREAMTOPICALWESTCORT

DISC RANBAXY LABS LTDOINTMENTTOPICALWESTCORT

DISC RANBAXY

20MGML

10MG25MG50MG100MG

25MG50MG100MG

HYDROCHLOROTHIAZIDE METOPROLOL TARTRATETABLETORALLOPRESSOR HCT

DISC US PHARMS HOLDINGS 50MG100MGI

HYDROCHLOROTHIAZIDE PROPRANOLOL HYDROCHLORIDE

25MG40MG

25MG80MG

25

02

02

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 28: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 28 of 50

HYDROXYPROGESTERONE CAPROATE

INJECTABLEINJECTION

DELALUTIN

DISC

DISC

DISC

DISC

BRISTOL MYERS

SQUIBB

125MGML

125MGML

250MGML

250MGML

N 010347 004 Jun 25 2010 Current OBYES

N 016911 001 Jun 25 2010 Current OBYES

N 010347 002 Jun 25 2010 Current OBYES

N 016911 002 Jun 25 2010 Current OBYES

HYDROXYZINE HYDROCHLORIDE

INJECTABLEINJECTION

VISTARIL

PFIZERDISC

DISC

TABLETORAL

ATARAX

25MGML

50MGML

N 011111 001 Nov 18 2016 Current OBYES

N 011111 002 Nov 18 2016 Current OBYES

PFIZERDISC

DISC

DISC

DISC

10MG

25MG

50MG

100MG

N 010392 001 May 04 2016 Current OBYES

N 010392 004 May 04 2016 Current OBYES

N 010392 006 May 04 2016 Current OBYES

N 010392 005 May 04 2016 Current OBYES

HYDROXYZINE PAMOATE

CAPSULEORAL

VISTARIL

DISC PFIZER EQ 100MG HCL N 011459 006 Apr 28 2008 Current OBYES

IBANDRONATE SODIUM

TABLETORAL

BONIVA

DISC HOFFMANN LA ROCHE EQ 25MG BASE N 021455 001 Mar 11 2010 Current OBYES

IBUPROFEN

SUSPENSIONORAL

MOTRIN

MCNEIL CONSUMERDISC

TABLETORAL

MOTRIN

100MG5ML N 019842 001 Nov 18 2016 Current OBYES

MCNEIL CONSUMERDISC

DISC

DISC

DISC

300MG

400MG

600MG

800MG

N 017463 003 Aug 10 2010 Current OBYES

N 017463 002 Aug 10 2010 Current OBYES

N 017463 004 Aug 10 2010 Current OBYES

N 017463 005 Aug 10 2010 Current OBYES

IFOSFAMIDE

INJECTABLEINJECTION

IFEX

RX

RX

BAXTER HLTHCARE 1GMVIAL

3GMVIAL

N 019763 001 May 14 2002 Current OBNO

N 019763 002 May 14 2002 Current OBNO

IMATINIB MESYLATE

CAPSULEORAL

GLEEVEC

DISC NOVARTIS EQ 50MG BASE N 021335 001 Dec 07 2010 Current OBYES

DISC EQ 100MG BASE N 021335 002 Dec 07 2010 Current OBYES

IMIPRAMINE PAMOATE

CAPSULEORAL

TOFRANIL-PM

DISC

DISC

DISC

DISC

MALLINCKRODT INC EQ 75MG HCL

EQ 100MG HCL

EQ 125MG HCL

EQ 150MG HCL

N 017090 001 Sep 06 2016 Current OBYES

N 017090 004 Sep 06 2016 Current OBYES

N 017090 003 Sep 06 2016 Current OBYES

N 017090 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 29: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 29 of 50

INDAPAMIDETABLETORALLOZOL

DISC SANOFI AVENTIS US 125MG N 018538 002 May 14 2009 Current OBYESDISC 25MG N 018538 001 May 14 2009 Current OBYES

INDOMETHACINCAPSULE EXTENDED RELEASEORALINDOCIN SR

DISC IROKO PHARMS 75MG N 018185 001 Mar 15 2016 Current OBYESCAPSULEORALINDOCIN

DISC IROKO PHARMS LLC 25MG N 016059 001 Mar 15 2016 Current OBYESDISC 50MG N 016059 002 Mar 15 2016 Current OBYESSUPPOSITORYRECTALINDOCIN

DISC IROKO PHARMS 50MG N 017814 001 Aug 06 2003 Current OBYES

IPRATROPIUM BROMIDESOLUTIONINHALATIONATROVENT

DISC BOEHRINGER 002 N 020228 001 Oct 01 2008 Current OBYESINGELHEIM

ISOSORBIDE DINITRATETABLETORALISORDIL

DISC VALEANT PHARMS

NORTH

10MG N 012093 002 Jul 20 2015 Current OBYES

DISC 20MG N 012093 006 Jul 20 2015 Current OBYES

DISC 30MG N 012093 005 Jul 20 2015 Current OBYES

TABLETSUBLINGUAL

ISORDIL

DISC BIOVAIL 25MG N 012940 004 Jun 15 2009 Current OBYES

DISC 5MG N 012940 003 Jun 15 2009 Current OBYES

DISC 10MG N 012940 005 Jun 15 2009 Current OBYES

ISOSORBIDE DINITRATE

DISC

DISC

WATSON LABS 25MG

5MG

A 086033 001 Aug 19 2013 Current OBYES

A 086031 001 Aug 19 2013 Current OBYES

ISOSORBIDE MONONITRATE

TABLET EXTENDED RELEASEORAL

IMDUR

DISC SCHERING PLOUGH 30MG N 020225 001 Jun 15 2009 Current OBYES

DISC 60MG N 020225 002 Jun 15 2009 Current OBYES

DISC 120MG N 020225 003 Jun 15 2009 Current OBYES

ISOSULFAN BLUE

INJECTABLEINJECTION

LYMPHAZURIN

DISC COVIDIEN 1 N 018310 001 Jan 26 2015 Current OBYES

ISOTRETINOIN

CAPSULEORAL

ACCUTANE

DISC HOFFMANN LA ROCHE 10MG N 018662 002 Jul 07 2010 Current OBYES

DISC 20MG N 018662 004 Jul 07 2010 Current OBYES

DISC 40MG N 018662 003 Jul 07 2010 Current OBYES

ISRADIPINE

TABLET EXTENDED RELEASEORAL

DYNACIRC CR

DISC GLAXOSMITHKLINE

LLC

5MG N 020336 001 Nov 12 2013 Current OBYES

DISC 10MG N 020336 002 Nov 12 2013 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 30: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 30 of 50

KETOPROFENCAPSULE EXTENDED RELEASEORALORUVAIL

DISC WYETH PHARMS INC 100MG N 019816 003 Dec 19 2008 Current OBYESDISC 150MG N 019816 002 Dec 19 2008 Current OBYESDISC 200MG N 019816 001 Dec 19 2008 Current OBYESCAPSULEORALORUDIS

DISC WYETH AYERST 25MG N 018754 001 Apr 28 2008 Current OBYESDISC 50MG N 018754 002 Apr 28 2008 Current OBYESDISC 75MG N 018754 003 Apr 28 2008 Current OBYES

KETOROLAC TROMETHAMINEINJECTABLEINJECTIONKETOROLAC TROMETHAMINE

DISC WEST-WARD PHARMS 15MGML A 075222 001 Oct 31 2014 Current OBYESINT

DISC 30MGML A 075222 002 Oct 31 2014 Current OBYESDISC 30MGML A 075228 001 Oct 31 2014 Current OBYES

TORADOLDISC ROCHE PALO 15MGML N 019698 001 Aug 04 2004 Current OBYESDISC 30MGML N 019698 002 Aug 04 2004 Current OBYESTABLETORALTORADOL

DISC ROCHE PALO 10MG N 019645 001 Dec 19 2008 Current OBYES

LABETALOL HYDROCHLORIDEINJECTABLEINJECTIONTRANDATE

DISC SEBELA IRELAND LTD 5MGML N 019425 001 Mar 11 2010 Current OBYESTABLETORALNORMODYNE

DISC SCHERING 100MG N 018687 001 Sep 06 2016 Current OBYESDISC 200MG N 018687 002 Sep 06 2016 Current OBYESDISC 300MG N 018687 003 Sep 06 2016 Current OBYESDISC 400MG N 018687 004 Sep 06 2016 Current OBYES

TRANDATEDISC CNTY LINE PHARMS 400MG N 018716 004 Dec 28 2010 Current OBYES

LACTULOSESOLUTIONORALCHRONULAC

DISC SANOFI AVENTIS US 10GM15ML N 017884 001 Feb 18 2004 Current OBYESSOLUTIONORAL RECTALCEPHULAC

DISC SANOFI AVENTIS US 10GM15ML N 017657 001 Aug 06 2003 Current OBYES

LAMOTRIGINETABLETORALLAMICTAL

DISC GLAXOSMITHKLINE 50MG N 020241 006 Mar 05 2007 Current OBYESLLC

DISC 250MG N 020241 004 Mar 05 2007 Current OBYES

LANSOPRAZOLEINJECTABLEINTRAVENOUSPREVACID IV

DISC TAKEDA PHARMS NA 30MGVIAL N 021566 001 Sep 08 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

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See List Footnote

December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 31: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 31 of 50

LANSOPRAZOLE NAPROXENCAPSULE DELAYED REL PELLETS TABLETORALPREVACID NAPRAPAC 250 (COPACKAGED)

DISC TAKEDA PHARMS NA 15MGNANA250MG N 021507 002 Aug 07 2007 Current OBYES

LEUCOVORIN CALCIUMINJECTABLEINJECTIONLEUCOVORIN CALCIUM

DISC HOSPIRA EQ 3MG BASEML N 008107 001 May 04 2016 Current OBYESDISC EQ 50MG BASEVIAL N 008107 002 May 04 2016 Current OBYESDISC EQ 100MG BASEVIAL N 008107 004 May 04 2016 Current OBYESDISC EQ 350MG BASEVIAL N 008107 005 May 04 2016 Current OBYES

LEUCOVORIN CALCIUM PRESERVATIVE FREEDISC HOSPIRA EQ 10MG BASEML A 040147 001 Jun 16 2014 Current OBYES

LEUPROLIDE ACETATEINJECTABLEINJECTIONLUPRON DEPOT

DISC ABBVIE ENDOCRINE 375MGVIAL N 020011 001 Oct 08 2014 Current OBYESINCLUPRON DEPOT-PED

DISC ABBVIE ENDOCRINE 375MGVIAL75MGVIAL375MGV N 020263 003 Aug 20 2014 Current OBYESINC IAL75MGVIAL

DISC 75MGVIAL75MGVIAL75MGVIA N 020263 004 Aug 20 2014 Current OBYESL75MGVIAL

LEVOFLOXACININJECTABLEINJECTIONLEVAQUIN IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC JANSSEN PHARMS EQ 250MG50ML (EQ 5MGML) N 020635 002 Nov 18 2016 Current OBYESDISC EQ 500MG100ML (EQ 5MGML) N 020635 003 Nov 18 2016 Current OBYESDISC EQ 750MG150ML (EQ 5MGML) N 020635 005 Nov 18 2016 Current OBYESSOLUTIONDROPSOPHTHALMICIQUIX

DISC SANTEN 15 N 021571 001 Jan 09 2015 Current OBYESQUIXIN

DISC SANTEN 05 N 021199 001 Dec 04 2015 Current OBYES

LEVOLEUCOVORIN CALCIUMSOLUTIONIV (INFUSION)FUSILEV

DISC SPECTRUM PHARMS EQ 175MG BASE175ML (EQ 10MG N 020140 002 Aug 22 2014 Current OBYESBASEML)

DISC EQ 250MG BASE25ML (EQ 10MG N 020140 003 Aug 22 2014 Current OBYESBASEML)

LEVOMETHADYL ACETATE HYDROCHLORIDECONCENTRATEORALORLAAM

DISC ROXANE 10MGML N 020315 001 Jun 06 2011 Current OBYES

LEVONORGESTRELIMPLANTIMPLANTATIONJADELLE

DISC POPULATION COUNCIL 75MGIMPLANT N 020544 001 Aug 29 2014 Current OBYESTABLETORALLEVONORGESTREL

DISC WATSON LABS 075MG A 078665 001 Sep 06 2016 Current OBYESPLAN B

DISC TEVA BRANDED PHARM 075MG N 021045 001 Sep 06 2016 Current OBYESDISC 075MG N 021045 002 Sep 06 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 32: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 32 of 50

LEVOTHYROXINE SODIUM

TABLETORAL

LEVOTHROID

LLOYDDISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

DISC

LEVOXYL

KING PHARMS R AND

D

DISC

0025MG

005MG

0075MG

0088MG

01MG

0112MG

0125MG

0137MG

015MG

0175MG

02MG

03MG

03MG

N 021116 001 May 31 2016 Current OBYES

N 021116 002 May 31 2016 Current OBYES

N 021116 003 May 31 2016 Current OBYES

N 021116 010 May 31 2016 Current OBYES

N 021116 004 May 31 2016 Current OBYES

N 021116 011 May 31 2016 Current OBYES

N 021116 005 May 31 2016 Current OBYES

N 021116 012 May 31 2016 Current OBYES

N 021116 006 May 31 2016 Current OBYES

N 021116 007 May 31 2016 Current OBYES

N 021116 008 May 31 2016 Current OBYES

N 021116 009 May 31 2016 Current OBYES

N 021301 012 Jun 15 2009 Current OBYES

LIDOCAINE

OINTMENTTOPICAL

XYLOCAINE

ASTRAZENECADISC 5 N 008048 001 Nov 18 2016 Current OBYES

LINEZOLID

TABLETORAL

ZYVOX

PHARMACIA AND

UPJOHN

DISC 400MG N 021130 001 Jun 30 2005 Current OBYES

LITHIUM CARBONATE

TABLET EXTENDED RELEASEORAL

ESKALITH CR

JDS PHARMS 450MGDISC N 018152 001 Apr 28 2008 Current OBYES

LOVASTATIN

TABLETORAL

MEVACOR

MERCKDISC

DISC

DISC

10MG

20MG

40MG

N 019643 002 Mar 07 2008 Current OBYES

N 019643 003 Jan 21 2016 Current OBYES

N 019643 004 Jan 21 2016 Current OBYES

LOXAPINE SUCCINATE

CAPSULEORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

DISC

TABLETORAL

LOXITANE

ACTAVIS LABS UT

INC

DISC

DISC

DISC

EQ 5MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

N 017525 001 Sep 23 2011 Current OBYES

N 017525 002 Sep 23 2011 Current OBYES

N 017525 003 Sep 23 2011 Current OBYES

N 017525 004 Sep 23 2011 Current OBYES

N 017525 006 Sep 23 2011 Current OBYES

N 017525 007 Sep 23 2011 Current OBYES

N 017525 008 Sep 23 2011 Current OBYES

MAGNESIUM SULFATE POLYETHYLENE GLYCOL 3350 POTASSIUM CHLORIDE POTASSIUM SULFATE SODIUMBICARBONATE SODIUM CHLORIDE SODIUM SULFATESOLUTIONORALSUCLEAR

DISC BRAINTREE LABS 16GM210GM074GM313GM286G N 203595 001 Jan 21 2016 Current OBYESM56GM175GM

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

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December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 33: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

N 017247 001 Jul 15 2008N 017247 002 Jul 15 2008

N 017481 001 Sep 06 2007

N 010251 001 Jul 22 2011

N 012541 002 May 15 1996

N 016979 001 Mar 02 2011

N 016979 002 Mar 02 2011

N 006008 001 Dec 03 2009

N 012125 003 Apr 28 2008

N 009698 004 Sep 06 2007

N 009698 002 Sep 06 2007

N 009053 002 Dec 04 2015

N 019919 001 May 24 2001

N 009509 002 Apr 28 2008

N 013217 001 Apr 07 2014

Page 33 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBNO

Current OBYES

Current OBYES

Current OBYES

MAZINDOLTABLETORALSANOREX

DISC NOVARTISDISC

MEBENDAZOLETABLET CHEWABLEORALVERMOX

DISC JANSSEN PHARMS

MECAMYLAMINE HYDROCHLORIDETABLETORALINVERSINE

DISC TARGACEPT 25MG

MEDROXYPROGESTERONE ACETATEINJECTABLEINJECTIONDEPO-PROVERA

DISC PHARMACIA ANDUPJOHN

MEGESTROL ACETATETABLETORALMEGACE

DISC BRISTOL MYERSSQUIBB

DISC

MEPHENYTOINTABLETORALMESANTOIN

DISC NOVARTIS

1MG2MG

100MG

MEPIVACAINE HYDROCHLORIDE

100MGML

20MG

40MG

100MG

INJECTABLEINJECTIONCARBOCAINE

DISC EASTMAN KODAK

MEPROBAMATETABLETORALMILTOWN

DISC MEDPOINTE PHARM

HLC

DISC

MERCAPTOPURINETABLETORALPURINETHOL

RX STASON PHARMS

MESALAMINESUPPOSITORYRECTALROWASA

DISC MEDA PHARMS

METARAMINOL BITARTRATEINJECTABLEINJECTIONARAMINE

DISC MERCK

METAXALONETABLETORALSKELAXIN

DISC KING PHARMS

3

200MG

400MG

50MG

500MG

EQ 10MG BASEML

400MG

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 34: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 34 of 50

METFORMIN HYDROCHLORIDETABLETORALGLUCOPHAGE

DISC BRISTOL MYERS 625MG N 020357 003 May 24 2001 Current OBYESSQUIBB

DISC 750MG N 020357 004 Jun 20 2001 Current OBYES

METFORMIN HYDROCHLORIDE ROSIGLITAZONE MALEATETABLETORALAVANDAMET

DISC SB PHARMCO 1GMEQ 2MG BASE N 021410 004 Aug 08 2016 Current OBYESDISC 1GMEQ 4MG BASE N 021410 005 Aug 08 2016 Current OBYESDISC 500MGEQ 1MG BASE N 021410 001 Jan 09 2015 Current OBYESDISC 500MGEQ 2MG BASE N 021410 002 Aug 08 2016 Current OBYESDISC 500MGEQ 4MG BASE N 021410 003 Aug 08 2016 Current OBYES

METHAZOLAMIDETABLETORALNEPTAZANE

DISC LEDERLE 25MG N 011721 002 Aug 08 2016 Current OBYESDISC 50MG N 011721 001 Aug 08 2016 Current OBYES

METHIMAZOLETABLETORALTAPAZOLE

DISC KING PHARMS 5MG N 007517 002 Apr 28 2008 Current OBYESDISC 10MG N 007517 004 Apr 28 2008 Current OBYES

METHOTREXATE SODIUMINJECTABLEINJECTIONMETHOTREXATE PRESERVATIVE FREE

DISC HOSPIRA EQ 500MG BASE20ML (EQ 25MG N 011719 013 Aug 08 2007 Current OBYESBASEML)

METHYCLOTHIAZIDETABLETORALENDURON

DISC ABBVIE 25MG N 012524 001 Sep 27 2012 Current OBYESDISC 5MG N 012524 004 Sep 27 2012 Current OBYES

METHYLDOPATABLETORALALDOMET

DISC MERCK 125MG N 013400 003 May 23 2007 Current OBYESDISC 250MG N 013400 001 May 23 2007 Current OBYESDISC 500MG N 013400 002 May 23 2007 Current OBYES

METHYLDOPATE HYDROCHLORIDEINJECTABLEINJECTIONALDOMET

DISC MERCK 50MGML N 013401 001 May 23 2007 Current OBYES

METHYLPHENIDATE HYDROCHLORIDETABLET CHEWABLEORALMETHYLIN

DISC MALLINCKRODT 25MG N 021475 001 Mar 15 2016 Current OBYESDISC 5MG N 021475 002 Mar 15 2016 Current OBYESDISC 10MG N 021475 003 Mar 15 2016 Current OBYESTABLET EXTENDED RELEASEORALMETADATE ER

DISC UCB INC 10MG A 040306 001 Jul 05 2013 Current OBNO

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 35: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 35 of 50

METOCLOPRAMIDE HYDROCHLORIDESOLUTIONORALREGLAN

DISC ROBINS AH EQ 5MG BASE5ML N 018821 001 May 14 2009 Current OBYESTABLET ORALLY DISINTEGRATINGORALMETOZOLV ODT

DISC SALIX PHARMS EQ 10MG BASE N 022246 002 Aug 14 2014 Current OBYES

MIDAZOLAM HYDROCHLORIDEINJECTABLEINJECTIONVERSED

DISC HLR EQ 1MG BASEML N 018654 002 Aug 06 2003 Current OBYESDISC EQ 5MG BASEML N 018654 001 Aug 06 2003 Current OBYESSYRUPORALVERSED

DISC ROCHE EQ 2MG BASEML N 020942 001 Aug 06 2003 Current OBYES

MILRINONE LACTATEINJECTABLEINJECTIONPRIMACOR

DISC SANOFI AVENTIS US EQ 1MG BASEML N 019436 001 Aug 10 2010 Current OBYESPRIMACOR IN DEXTROSE 5 IN PLASTIC CONTAINER

DISC SANOFI AVENTIS US EQ 10MG BASE100ML N 020343 001 Nov 18 2016 Current OBYESDISC EQ 15MG BASE100ML N 020343 002 Nov 18 2016 Current OBYESDISC EQ 20MG BASE100ML (EQ 02MG N 020343 003 Nov 18 2016 Current OBYES

BASEML)DISC EQ 40MG BASE200ML (EQ 02MG N 020343 004 Nov 18 2016 Current OBYES

BASEML)

MINOCYCLINE HYDROCHLORIDECAPSULEORALMINOCIN

DISC PRECISION DERMAT EQ 75MG BASE N 050649 003 Feb 29 2008 Current OBYESTABLET EXTENDED RELEASEORALSOLODYN

DISC MEDICIS EQ 45MG BASE N 050808 001 Nov 12 2013 Current OBYESDISC EQ 90MG BASE N 050808 002 Nov 12 2013 Current OBYESDISC EQ 135MG BASE N 050808 003 Nov 12 2013 Current OBYESTABLETORALMINOCYCLINE HYDROCHLORIDE

DISC TRIAX PHARMS EQ 50MG BASE N 050451 003 Jan 27 1998 Current OBYESDISC EQ 100MG BASE N 050451 002 Jan 27 1998 Current OBYES

MINOXIDILTABLETORALLONITEN

DISC PHARMACIA AND 25MG N 018154 001 Jun 15 2009 Current OBYESUPJOHN

DISC 10MG N 018154 003 Jun 15 2009 Current OBYES

MITOMYCININJECTABLEINJECTIONMITOZYTREX

DISC SUPERGEN 5MGVIAL N 050763 001 Aug 19 2013 Current OBYES

MITOXANTRONE HYDROCHLORIDEINJECTABLEINJECTIONNOVANTRONE

DISC EMD SERONO EQ 25MG BASE125ML (EQ 2MG N 019297 002 Apr 13 2011 Current OBYESBASEML)

DISC EQ 30MG BASE15ML (EQ 2MG N 019297 003 Apr 13 2011 Current OBYESBASEML)

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December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

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December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

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December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

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December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

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December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

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December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

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December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

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SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 36: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 36 of 50

MIVACURIUM CHLORIDESOLUTIONINTRAVENOUSMIVACRON

DISC ABBVIE EQ 2MG BASEML (EQ 2MG BASEML) N 020098 001 Aug 07 2007 Current OBYES

MOLINDONE HYDROCHLORIDECAPSULEORALMOBAN

DISC ENDO PHARMS 5MG N 017111 001 Nov 06 2013 Current OBYESDISC 10MG N 017111 002 Nov 06 2013 Current OBYESDISC 25MG N 017111 003 Nov 06 2013 Current OBYESTABLETORALMOBAN

DISC ENDO PHARMS 5MG N 017111 004 Nov 06 2013 Current OBYESDISC 10MG N 017111 005 Nov 06 2013 Current OBYESDISC 25MG N 017111 006 Nov 06 2013 Current OBYESDISC 50MG N 017111 007 Nov 06 2013 Current OBYESDISC 100MG N 017111 008 Nov 06 2013 Current OBYES

NABUMETONETABLETORALRELAFEN

DISC SMITHKLINE BEECHAM 500MG N 019583 001 Mar 07 2008 Current OBYESDISC 750MG N 019583 002 Mar 07 2008 Current OBYES

NAFCILLIN SODIUMINJECTABLEINJECTIONUNIPEN

DISC WYETH AYERST EQ 1GM BASEVIAL A 062717 002 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062717 004 Mar 15 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050320 003 Mar 15 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050320 004 Mar 15 2016 Current OBYESDISC EQ 10GM BASEVIAL N 050320 005 Mar 15 2016 Current OBYESDISC EQ 20GM BASEVIAL N 050320 006 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL A 062717 001 Mar 15 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050320 001 Mar 15 2016 Current OBYES

UNIPEN IN PLASTIC CONTAINERDISC WYETH AYERST EQ 1GM BASEVIAL N 050320 002 Mar 15 2016 Current OBYES

NALBUPHINE HYDROCHLORIDEINJECTABLEINJECTIONNUBAIN

DISC PAR PHARM INC 10MGML N 018024 001 Nov 21 2008 Current OBYESDISC 20MGML N 018024 002 Nov 21 2008 Current OBYES

NALOXONE HYDROCHLORIDEINJECTABLEINJECTIONNARCAN

DISC ADAPT 002MGML N 016636 002 May 14 2009 Current OBYESDISC 04MGML N 016636 001 May 14 2009 Current OBYESDISC 1MGML N 016636 003 May 14 2009 Current OBYES

NANDROLONE DECANOATEINJECTABLEINJECTIONDECA-DURABOLIN

DISC ASPEN GLOBAL INC 200MGML N 013132 003 Aug 10 2010 Current OBYES

NAPHAZOLINE HYDROCHLORIDESOLUTIONDROPSOPHTHALMICALBALON

DISC ALLERGAN 01 A 080248 001 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 37: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 37 of 50

NEFAZODONE HYDROCHLORIDETABLETORALSERZONE

DISC BRISTOL MYERS 50MG N 020152 001 Oct 26 2004 Current OBYESSQUIBB

DISC 100MG N 020152 002 Oct 26 2004 Current OBYESDISC 150MG N 020152 003 Oct 26 2004 Current OBYESDISC 200MG N 020152 004 Oct 26 2004 Current OBYESDISC 250MG N 020152 005 Oct 26 2004 Current OBYESDISC 300MG N 020152 006 Oct 26 2004 Current OBYES

NIFEDIPINECAPSULEORALPROCARDIA

DISC PFIZER 20MG N 018482 002 Mar 02 2011 Current OBYES

NIMODIPINECAPSULEORALNIMOTOP

DISC BAYER PHARMS 30MG N 018869 001 Apr 02 2014 Current OBYES

NISOLDIPINETABLET EXTENDED RELEASEORALSULAR

DISC COVIS PHARMA SARL 10MG N 020356 001 Aug 25 2014 Current OBYESDISC 20MG N 020356 002 Aug 25 2014 Current OBYESDISC 255MG N 020356 006 Aug 25 2014 Current OBYESDISC 30MG N 020356 003 Aug 25 2014 Current OBYESDISC 40MG N 020356 004 Aug 25 2014 Current OBYES

NITRIC OXIDEGASINHALATIONINOMAX

DISC MALLINCKRODT HOSP 100PPM N 020845 002 Jan 21 2016 Current OBYES

NITROGLYCERINFILM EXTENDED RELEASETRANSDERMALTRANSDERM-NITRO

DISC NOVARTIS 01MGHR N 020144 001 May 23 2007 Current OBYESDISC 02MGHR N 020144 002 May 23 2007 Current OBYESDISC 04MGHR N 020144 003 May 23 2007 Current OBYESDISC 06MGHR N 020144 004 May 23 2007 Current OBYESDISC 08MGHR N 020144 005 May 23 2007 Current OBYESINJECTABLEINJECTIONNITROGLYCERIN

DISC HOSPIRA 5MGML N 018531 001 Nov 12 2013 Current OBYES

NIZATIDINESOLUTIONORALAXID

DISC BRAINTREE 15MGML N 021494 001 Aug 08 2016 Current OBYES

NORTRIPTYLINE HYDROCHLORIDESOLUTIONORALAVENTYL

DISC RANBAXY EQ 10MG BASE5ML N 014685 001 Aug 14 2014 Current OBYES

NYSTATINCREAMTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060575 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

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See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

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See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

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See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 38: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 38 of 50

OINTMENTTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060571 001 Dec 04 2015 Current OBYESPOWDERORALNILSTAT

DISC DAVA PHARMS INC 100 N 050576 001 Mar 02 2011 Current OBYESPOWDERTOPICALMYCOSTATIN

DISC DELCOR ASSET CORP 100000 UNITSGM A 060578 001 Dec 04 2015 Current OBYESTABLETORALNILSTAT

DISC LEDERLE 500000 UNITS A 061151 001 Mar 02 2011 Current OBNO

NYSTATIN TRIAMCINOLONE ACETONIDECREAMTOPICALMYCOLOG-II

DISC DELCOR ASSET CORP 100000 UNITSGM01 A 060576 002 Mar 15 2016 Current OBYESDISC MYLAN PHARMS INC 100000 UNITSGM01 A 062606 001 Mar 15 2016 Current OBYESOINTMENTTOPICALMYCOLOG-II

DISC MYLAN PHARMS INC 100000 UNITSGM01 A 060572 001 Jun 06 2016 Current OBYES

OFLOXACINSOLUTIONDROPSOTICFLOXIN OTIC

DISC DAIICHI 03 N 020799 001 Sep 06 2016 Current OBYES

OMEPRAZOLECAPSULE DELAYED REL PELLETSORALPRILOSEC

DISC ASTRAZENECA PHARMS 10MG N 019810 003 Sep 06 2016 Current OBYESDISC 20MG N 019810 001 Sep 06 2016 Current OBYESDISC 40MG N 019810 002 Sep 06 2016 Current OBYES

ONDANSETRON HYDROCHLORIDEINJECTABLEINJECTIONZOFRAN AND DEXTROSE IN PLASTIC CONTAINER

DISC GLAXOSMITHKLINE EQ 064MG BASEML N 020403 001 Sep 23 2011 Current OBYES

OXACILLIN SODIUMINJECTABLEINJECTIONBACTOCILL

DISC GLAXOSMITHKLINE EQ 1GM BASEVIAL A 061334 006 Apr 04 2016 Current OBYESDISC EQ 1GM BASEVIAL A 062736 001 May 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 061334 007 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL A 062736 002 May 04 2016 Current OBYESDISC EQ 4GM BASEVIAL A 061334 008 Apr 04 2016 Current OBYESDISC EQ 10GM BASEVIAL A 061334 010 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL A 061334 009 Apr 04 2016 Current OBYES

OXACILLIN SODIUMDISC APOTHECON EQ 1GM BASEVIAL N 050195 003 Apr 04 2016 Current OBYESDISC EQ 2GM BASEVIAL N 050195 004 Apr 04 2016 Current OBYESDISC EQ 4GM BASEVIAL N 050195 005 Apr 04 2016 Current OBYESDISC EQ 250MG BASEVIAL N 050195 001 Apr 04 2016 Current OBYESDISC EQ 500MG BASEVIAL N 050195 002 Apr 04 2016 Current OBYES

OXALIPLATININJECTABLEIV (INFUSION)ELOXATIN

DISC SANOFI AVENTIS US 50MGVIAL N 021492 001 Nov 26 2007 Current OBYESDISC 100MGVIAL N 021492 002 Nov 26 2007 Current OBYESDISC 200MG40ML (5MGML) N 021759 003 Nov 18 2016 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 39: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 39 of 50

OXYBUTYNIN CHLORIDESYRUPORALDITROPAN

DISC ORTHO MCNEIL 5MG5ML N 018211 001 Nov 18 2016 Current OBYESJANSSEN

TABLETORALDITROPAN

DISC JANSSEN PHARMS 5MG N 017577 001 Sep 27 2012 Current OBYES

OXYMORPHONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOPANA ER

DISC ENDO PHARMS 5MG N 021610 001 Jun 25 2013 Current OBYESDISC 75MG N 021610 005 Aug 30 2011 Current OBYESDISC 10MG N 021610 002 Jun 25 2013 Current OBYESDISC 15MG N 021610 006 Aug 30 2011 Current OBYESDISC 20MG N 021610 003 Jun 25 2013 Current OBYESDISC 40MG N 021610 004 Jun 25 2013 Current OBYES

OXYTOCININJECTABLEINJECTIONOXYTOCIN 10 USP UNITS IN DEXTROSE 5

DISC ABBOTT 1USP UNITS100ML N 019185 004 Apr 22 2015 Current OBYESDISC 2USP UNITS100ML N 019185 003 Apr 22 2015 Current OBYES

OXYTOCIN 20 USP UNITS IN DEXTROSE 5DISC ABBOTT 2USP UNITS100ML N 019185 002 Apr 22 2015 Current OBYES

OXYTOCIN 5 USP UNITS IN DEXTROSE 5DISC ABBOTT 1USP UNITS100ML N 019185 001 Apr 22 2015 Current OBYES

PACLITAXELINJECTABLEINJECTIONTAXOL

RX HQ SPCLT PHARMA 6MGML N 020262 001 Mar 02 2011 Current OBNO

PALIPERIDONETABLET EXTENDED RELEASEORALINVEGA

DISC JANSSEN PHARMS 12MG N 021999 004 Nov 04 2013 Current OBYES

PALONOSETRON HYDROCHLORIDECAPSULEORALALOXI

DISC HELSINN HLTHCARE EQ 05MG BASE N 022233 001 Sep 04 2012 Current OBYES

PAMIDRONATE DISODIUMINJECTABLEINJECTIONAREDIA

DISC NOVARTIS 30MGVIAL N 020036 001 Sep 27 2012 Current OBYES

PAROXETINE HYDROCHLORIDECAPSULEORALPAXIL

DISC APOTEX EQ 10MG BASE N 020885 001 Jun 21 2000 Current OBYESTECHNOLOGIES

DISC EQ 20MG BASE N 020885 002 Jun 21 2000 Current OBYESDISC EQ 30MG BASE N 020885 003 Jun 21 2000 Current OBYESDISC EQ 40MG BASE N 020885 004 Jun 21 2000 Current OBYES

PENBUTOLOL SULFATETABLETORALLEVATOL

DISC AUXILIUM PHARMS 10MG N 018976 001 Jan 09 2015 Current OBYESLLC

DISC 20MG N 018976 004 Jan 09 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 40: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 40 of 50

PENICILLIN G POTASSIUM

INJECTABLEINJECTION

PENICILLIN G POTASSIUM

SANDOZ 1000000 UNITSVIALDISC

PFIZERPEN

PFIZER 1000000 UNITSVIALDISC

A 065079 001 Dec 05 2014 Current OBYES

A 060657 001 Dec 11 2014 Current OBYES

PENICILLIN V POTASSIUM

TABLETORAL

V-CILLIN K

LILLYDISC

DISC

DISC

EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A 060003 001 Nov 18 2016 Current OBYES

A 060003 002 Nov 18 2016 Current OBYES

A 060003 003 Nov 18 2016 Current OBYES

PENTAGASTRIN

INJECTABLEINJECTION

PEPTAVLON

WYETH AYERSTDISC 025MGML N 017048 001 Feb 10 2006 Current OBYES

PENTETATE CALCIUM TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE CALCIUM TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTETATE ZINC TRISODIUM

SOLUTIONINHALATION INTRAVENOUS

PENTETATE ZINC TRISODIUM

HAMELN PHARMA PLUS EQ 1GM BASE5ML (EQ 200MG

BASEML)

RX

PENTOXIFYLLINE

TABLET EXTENDED RELEASEORAL

TRENTAL

US PHARM HOLDINGS 400MGDISC

N 021749 001 Aug 19 2011 Current OBYES

N 021751 001 Aug 19 2011 Current OBYES

N 018631 001 Nov 18 2016 Current OBYES

PERPHENAZINE

TABLETORAL

TRILAFON

SCHERINGDISC

DISC

DISC

DISC

2MG

4MG

8MG

16MG

N 010775 001 Oct 01 2003 Current OBYES

N 010775 002 Oct 01 2003 Current OBYES

N 010775 003 Oct 01 2003 Current OBYES

N 010775 004 Oct 01 2003 Current OBYES

PHENACEMIDE

TABLETORAL

PHENURONE

ABBVIEDISC 500MG N 007707 001 Feb 29 2012 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFAMETHOXAZOLE

TABLETORAL

AZO GANTANOL

ROCHE 100MG500MGDISC N 013294 001 Jun 12 2014 Current OBYES

PHENAZOPYRIDINE HYDROCHLORIDE SULFISOXAZOLE

TABLETORAL

AZO GANTRISIN

ROCHE 50MG500MGDISC N 019358 001 Jun 12 2014 Current OBYES

PHENTERMINE HYDROCHLORIDE

TABLETORAL

WILPO

SANDOZ 8MGDISC N 012737 001 Feb 13 2012 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 41: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016

PHENTERMINE RESIN COMPLEXCAPSULE EXTENDED RELEASEORALIONAMIN

DISC UCB INC EQ 15MG BASEDISC EQ 30MG BASE

PHENYLEPHRINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDESYRUPORALPHENERGAN VC

DISC ANI PHARMS

PHYTONADIONEINJECTABLEINJECTIONAQUAMEPHYTON

DISC TELIGENT PHARMA

INC

DISC

PINDOLOLTABLETORALVISKEN

DISC NOVARTISDISC

PIPERACILLIN SODIUMINJECTABLEINJECTIONPIPRACIL

DISC WYETH PHARMS INCDISCDISCDISC

POTASSIUM CHLORIDE

5MG5ML625MG5ML

1MG05ML

10MGML

5MG10MG

EQ 2GM BASEVIALEQ 3GM BASEVIALEQ 4GM BASEVIALEQ 40GM BASEVIAL

TABLET EXTENDED RELEASEORALPOTASSIUM CHLORIDE

DISC SCHERINGDISC

POTASSIUM CITRATEFOR SOLUTIONORALPOTASSIUM CITRATE

DISC UT SW MEDCTRDISC

PRAVASTATIN SODIUMTABLETORALPRAVACHOL

DISC BRISTOL MYERSSQUIBB

10MEQ20MEQ

10MEQPACKET20MEQPACKET

10MG

PREDNISOLONE SODIUM PHOSPHATESOLUTIONORALORAPRED

DISC CONCORDIA PHARMS EQ 15MG BASE5MLINC

PREDNISOLONE SODIUM PHOSPHATE SULFACETAMIDE SODIUMSOLUTIONDROPSOPHTHALMICVASOCIDIN

DISC NOVARTIS EQ 023 PHOSPHATE10

PREDNISONETABLETORALDELTASONE

DISC PHARMACIA AND 25MG

UPJOHN

DISC 5MG

N 011613 004 Dec 19 2008N 011613 002 Dec 19 2008

N 008604 003 Apr 28 2008

N 012223 002 Sep 06 2016

N 012223 001 Sep 06 2016

N 018285 001 Jun 15 2009N 018285 002 Jun 15 2009

N 050545 002 Oct 29 2003N 050545 003 Oct 29 2003N 050545 004 Oct 29 2003N 050545 006 Jul 03 2002

N 019439 002 Jun 06 2016N 019439 001 Jun 06 2016

N 019647 002 Oct 23 2013N 019647 001 Oct 23 2013

N 019898 002 Jul 20 2015

A 075117 001 Sep 06 2016

N 018988 001 Jul 20 2015

N 009986 005 May 04 2016

N 009986 002 May 04 2016

Page 41 of 50

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYESCurrent OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYESCurrent OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 42: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 42 of 50

TABLETORALDELTASONE

DISC 10MG N 009986 006 May 04 2016 Current OBYESDISC 20MG N 009986 007 May 04 2016 Current OBYESDISC 50MG N 009986 008 May 04 2016 Current OBYES

PRILOCAINE HYDROCHLORIDEINJECTABLEINJECTIONCITANEST

DISC ASTRAZENECA 1 N 014763 004 Mar 19 2012 Current OBYESDISC 2 N 014763 005 Mar 19 2012 Current OBYESDISC 3 N 014763 003 Mar 19 2012 Current OBYES

CITANEST PLAINDISC ASTRAZENECA 4 N 014763 007 Mar 19 2012 Current OBYES

PROBENECIDTABLETORALBENEMID

DISC MERCK 500MG N 007898 004 Nov 18 2016 Current OBYES

PROCAINAMIDE HYDROCHLORIDECAPSULEORALPRONESTYL

DISC APOTHECON 250MG N 007335 001 Apr 04 2016 Current OBYESDISC 375MG N 007335 004 Apr 04 2016 Current OBYESDISC 500MG N 007335 003 Apr 04 2016 Current OBYESINJECTABLEINJECTIONPRONESTYL

DISC APOTHECON 100MGML N 007335 002 Apr 04 2016 Current OBYESDISC 500MGML N 007335 005 Apr 04 2016 Current OBYES

PROMETHAZINE HYDROCHLORIDEINJECTABLEINJECTIONPHENERGAN

DISC WYETH AYERST 25MGML N 008857 002 May 23 2007 Current OBNODISC 50MGML N 008857 003 May 23 2007 Current OBNO

PROMETHAZINE HYDROCHLORIDEDISC TEVA PHARMS USA 25MGML A 040454 001 Jul 20 2015 Current OBYESDISC 50MGML A 040454 002 Jul 20 2015 Current OBYESSUPPOSITORYRECTALPHENERGAN

DISC MYLAN PHARMS INC 125MG N 010926 002 Aug 06 2007 Current OBYESDISC 25MG N 010926 001 Aug 06 2007 Current OBYESDISC 50MG N 011689 001 Apr 28 2008 Current OBYESSYRUPORALPROMETHAZINE HYDROCHLORIDE PLAIN

DISC ANI PHARMS 625MG5ML N 008381 004 Apr 28 2008 Current OBYESDISC 25MG5ML N 008381 003 Apr 28 2008 Current OBYESTABLETORALPHENERGAN

DISC DELCOR ASSET CORP 125MG N 007935 002 Jul 14 2006 Current OBYESDISC 25MG N 007935 003 Apr 28 2008 Current OBYESDISC 50MG N 007935 004 Jul 14 2006 Current OBYES

PROPANTHELINE BROMIDETABLETORALPRO-BANTHINE

DISC SHIRE 75MG N 008732 003 Mar 11 2010 Current OBYESDISC 15MG N 008732 002 Mar 11 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 43: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 43 of 50

PROPARACAINE HYDROCHLORIDE

SOLUTIONDROPSOPHTHALMIC

OPHTHAINE

APOTHECON 05DISC

OPHTHETIC

ALLERGAN 05DISC

N 008883 001 Dec 04 2015 Current OBYES

N 012583 001 Dec 04 2015 Current OBYES

PROPRANOLOL HYDROCHLORIDE

TABLETORAL

INDERAL

WYETH PHARMS INC 10MGDISC

20MGDISC

60MGDISC

80MGDISC

90MGDISC

N 016418 001 Jan 09 2008 Current OBYES

N 016418 003 Jan 09 2008 Current OBYES

N 016418 009 Aug 08 2016 Current OBYES

N 016418 004 Aug 14 2014 Current OBYES

N 016418 010 Jan 09 2008 Current OBYES

PROTAMINE SULFATE

INJECTABLEINJECTION

PROTAMINE SULFATE

LILLYDISC 10MGML N 006460 002 May 23 2007 Current OBYES

PYRIDOSTIGMINE BROMIDE

TABLETORAL

PYRIDOSTIGMINE BROMIDE

SOLVAY 30MGDISC A 089572 001 Jun 21 2005 Current OBNO

QUETIAPINE FUMARATE

TABLETORAL

SEROQUEL

ASTRAZENECA PHARMS EQ 150MG BASE DISC N 020639 004 Jan 25 2008 Current OBYES

RABEPRAZOLE SODIUM

TABLET DELAYED RELEASEORAL

ACIPHEX

EISAI INC 10MGDISC N 020973 001 Mar 28 2005 Current OBYES

RAMIPRIL

TABLETORAL

ALTACE

KING PFIZERDISC

DISC

DISC

DISC

125MG

25MG

5MG

10MG

N 022021 001 Nov 12 2013 Current OBYES

N 022021 002 Nov 12 2013 Current OBYES

N 022021 003 Nov 12 2013 Current OBYES

N 022021 004 Nov 12 2013 Current OBYES

RANITIDINE HYDROCHLORIDE

CAPSULEORAL

ZANTAC 150

GLAXOSMITHKLINE EQ 150MG BASEDISC

ZANTAC 300

GLAXOSMITHKLINE EQ 300MG BASEDISC

N 020095 001 Aug 06 2003 Current OBYES

N 020095 002 Aug 06 2003 Current OBYES

RISEDRONATE SODIUM

TABLETORAL

ACTONEL

APILDISC 75MG N 020835 004 Jul 07 2010 Current OBYES

ROCURONIUM BROMIDE

INJECTABLEINJECTION

ZEMURON

ORGANON USA INCDISC

DISC

DISC

50MG5ML (10MGML)

10MGML (10MGML)

100MG10ML (10MGML)

N 020214 001 Jan 26 2015 Current OBYES

N 020214 002 Jan 26 2015 Current OBYES

N 020214 003 Jan 26 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 44: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 44 of 50

ROPINIROLE HYDROCHLORIDE

TABLET EXTENDED RELEASEORAL

REQUIP XL

GLAXOSMITHKLINE

LLC

EQ 3MG BASEDISC N 022008 002 Feb 21 2012 Current OBYES

RUFINAMIDE

TABLETORAL

BANZEL

DISC EISAI INC 100MG N 021911 001 Nov 21 2013 Current OBYES

SAQUINAVIR

CAPSULEORAL

FORTOVASE

DISC HOFFMANN LA ROCHE 200MG N 020828 001 Sep 23 2011 Current OBYES

SELEGILINE HYDROCHLORIDE

TABLETORAL

SELEGILINE HYDROCHLORIDE

DISC SOMERSET 5MG N 019334 001 Aug 09 1996 Current OBYES

SERMORELIN ACETATE

INJECTABLEINJECTION

GEREF

DISC

DISC

DISC

EMD SERONO

EMD SERONO INC

EQ 005MG BASEAMP

EQ 05MG BASEVIAL

EQ 1MG BASEVIAL

N 019863 001 Mar 04 2013 Current OBYES

N 020443 001 Mar 04 2013 Current OBYES

N 020443 002 Mar 04 2013 Current OBYES

SERTRALINE HYDROCHLORIDE

TABLETORAL

ZOLOFT

DISC

DISC

PFIZER EQ 150MG BASE

EQ 200MG BASE

N 019839 003 Sep 17 2004 Current OBYES

N 019839 004 Sep 17 2004 Current OBYES

SIMVASTATIN SITAGLIPTIN PHOSPHATE

TABLETORAL

JUVISYNC

DISC MERCK SHARP DOHME 10MGEQ 50MG BASE N 202343 004 Feb 18 2014 Current OBYES

DISC 10MGEQ 100MG BASE N 202343 001 Feb 18 2014 Current OBYES

DISC 20MGEQ 50MG BASE N 202343 005 Feb 18 2014 Current OBYES

DISC 20MGEQ 100MG BASE N 202343 002 Feb 18 2014 Current OBYES

DISC 40MGEQ 50MG BASE N 202343 006 Feb 18 2014 Current OBYES

DISC 40MGEQ 100MG BASE N 202343 003 Feb 18 2014 Current OBYES

SIROLIMUS

TABLETORAL

RAPAMUNE

DISC PF PRISM CV 5MG N 021110 003 May 23 2007 Current OBYES

SODIUM BICARBONATE

INJECTABLEINJECTION

SODIUM BICARBONATE IN PLASTIC CONTAINER

DISC

DISC

ABBOTT 09MEQML

1MEQML

N 019443 001 Nov 29 2004 Current OBYES

N 019443 002 Nov 29 2004 Current OBYES

SODIUM FLUORIDE F-18

INJECTABLEINTRAVENOUS

FLUORINE F-18

GE HEALTHCAREDISC

SODIUM FLUORIDE F 18

2mCiML N 017042 001 Mar 10 2000 Current OBYES

NIH NCI DCTDDISC 10-200mCiML N 022494 001 Jun 24 2011 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 45: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 45 of 50

SODIUM NITROPRUSSIDEINJECTABLEINJECTIONNITROPRESS

DISC ABBVIE 50MGVIAL N 018450 001 Mar 15 2016 Current OBYESSODIUM NITROPRUSSIDE

DISC BAXTER HLTHCARE 50MGVIAL N 018581 001 Feb 18 2004 Current OBYES

SODIUM TETRADECYL SULFATEINJECTABLEINJECTIONSOTRADECOL

DISC ELKINS SINN 1 N 005970 004 Nov 07 2002 Current OBYESDISC 3 N 005970 005 Nov 07 2002 Current OBYES

SULFACETAMIDE SODIUMOINTMENTOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 002 May 13 2015 Current OBYESSOLUTIONDROPSOPHTHALMICSODIUM SULAMYD

DISC SCHERING 10 N 005963 001 May 13 2015 Current OBYESDISC 30 N 005963 003 May 13 2015 Current OBYES

SULFAMETHOXAZOLE TRIMETHOPRIMSUSPENSIONORALBACTRIM

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 001 Mar 15 2016 Current OBYESBACTRIM PEDIATRIC

DISC SUN PHARM INDS 200MG5ML40MG5ML N 017560 002 Mar 15 2016 Current OBYESSEPTRA

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 001 Mar 15 2016 Current OBYESSEPTRA GRAPE

DISC MONARCH PHARMS 200MG5ML40MG5ML N 017598 002 Mar 15 2016 Current OBYESSULFAMETHOXAZOLE AND TRIMETHOPRIM

DISC ANI PHARMS INC 200MG5ML40MG5ML A 077612 001 Apr 04 2016 Current OBYES

SULFINPYRAZONECAPSULEORALANTURANE

DISC NOVARTIS 200MG N 011556 004 Jun 15 2009 Current OBYESTABLETORALANTURANE

DISC NOVARTIS 100MG N 011556 003 Jun 15 2009 Current OBYES

SULINDACTABLETORALCLINORIL

DISC MERCK 150MG N 017911 001 Mar 02 2011 Current OBYESDISC 200MG N 017911 002 Sep 06 2016 Current OBYES

SUTILAINSOINTMENTTOPICALTRAVASE

DISC ABBOTT 82000 UNITSGM N 012828 001 Oct 19 1998 Current OBYES

TAMOXIFEN CITRATETABLETORALNOLVADEX

DISC ASTRAZENECA EQ 10MG BASE N 017970 001 Dec 19 2008 Current OBYESDISC EQ 20MG BASE N 017970 002 Dec 19 2008 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 46: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 46 of 50

TECHNETIUM TC-99M SODIUM PERTECHNETATE

SOLUTIONINJECTION ORAL

SODIUM PERTECHNETATE TC 99M

DISC

DISC

GE HEALTHCARE

MALLINCKRODT

2-100mCiML

10-60mCiML

N 017471 001 May 29 2014 Current OBYES

N 017725 001 May 29 2014 Current OBYES

TERAZOSIN HYDROCHLORIDE

CAPSULEORAL

HYTRIN

DISC

DISC

DISC

DISC

ABBOTT EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

N 020347 001 Aug 14 2014 Current OBYES

N 020347 002 Aug 14 2014 Current OBYES

N 020347 003 Aug 14 2014 Current OBYES

N 020347 004 Aug 14 2014 Current OBYES

TERBUTALINE SULFATE

INJECTABLEINJECTION

BRETHINE

PHARMACAREDISC

TABLETORAL

BRETHINE

1MGML N 018571 001 Jul 19 2007 Current OBYES

PHARMACARE LTDDISC 25MG N 017849 001 Dec 19 2008 Current OBYES

DISC 5MG N 017849 002 Dec 19 2008 Current OBYES

THEOPHYLLINE

SOLUTIONORAL

THEOPHYLLINE

DISC ROXANE 80MG15ML A 087449 001 Feb 22 2011 Current OBNO

THIORIDAZINE HYDROCHLORIDE

TABLETORAL

MELLARIL

DISC

DISC

DISC

DISC

DISC

DISC

DISC

NOVARTIS 10MG

15MG

25MG

50MG

100MG

150MG

200MG

N 011808 003 May 23 2007 Current OBYES

N 011808 016 May 23 2007 Current OBYES

N 011808 006 May 23 2007 Current OBYES

N 011808 011 May 23 2007 Current OBYES

N 011808 009 May 23 2007 Current OBYES

N 011808 017 May 23 2007 Current OBYES

N 011808 015 May 23 2007 Current OBYES

THIOTEPA

INJECTABLEINJECTION

THIOPLEX

IMMUNEXDISC

THIOTEPA

15MGVIAL N 020058 001 Feb 18 2004 Current OBYES

TEVA PARENTERALDISC

DISC

15MGVIAL

30MGVIAL

A 075730 001 Apr 04 2016 Current OBYES

A 075730 002 Apr 04 2016 Current OBYES

TILUDRONATE DISODIUM

TABLETORAL

SKELID

DISC SANOFI AVENTIS US EQ 200MG BASE N 020707 001 Feb 18 2014 Current OBYES

TIZANIDINE HYDROCHLORIDE

TABLETORAL

ZANAFLEX

DISC ACORDA EQ 2MG BASE N 020397 002 May 14 2009 Current OBYES

TOBRAMYCIN SULFATE

INJECTABLEINJECTION

NEBCIN

LILLY EQ 12GM BASEVIALDISC

EQ 10MG BASEMLDISC

EQ 40MG BASEMLDISC

TOBRAMYCIN SULFATE (PHARMACY BULK)

HOSPIRA EQ 40MG BASEMLDISC

N 050519 001 May 23 2007 Current OBYES

N 050477 005 May 23 2007 Current OBYES

A 062008 001 May 23 2007 Current OBNO

A 063116 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 47: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 47 of 50

TOLAZAMIDETABLETORALTOLINASE

DISC PHARMACIA AND 100MG N 015500 002 Jun 15 2009 Current OBYESUPJOHN

DISC 250MG N 015500 004 Jun 15 2009 Current OBYESDISC 500MG N 015500 005 Jun 15 2009 Current OBYES

TOLVAPTANTABLETORALSAMSCA

DISC OTSUKA AMERICA 60MG N 022275 003 Aug 02 2016 Current OBYESPHARM

TOPOTECAN HYDROCHLORIDESOLUTIONINTRAVENOUSTOPOTECAN

DISC SANDOZ INC EQ 1MG BASEML (EQ 1MG BASEML) N 200199 001 Jul 13 2012 Current OBYESDISC EQ 3MG BASE3ML (EQ 1MG N 200199 002 Jul 13 2012 Current OBYES

BASEML)DISC EQ 4MG BASE4ML (EQ 1MG N 200199 003 Jul 13 2012 Current OBYES

BASEML)

TORSEMIDEINJECTABLEINJECTIONDEMADEX

DISC ROCHE 50MG5ML (10MGML) N 020137 002 Aug 17 2009 Current OBYESDISC 20MG2ML (10MGML) N 020137 001 Aug 17 2009 Current OBYES

TRAMADOL HYDROCHLORIDETABLET EXTENDED RELEASEORALRYZOLT

DISC PURDUE PHARMA 100MG N 021745 001 Nov 12 2013 Current OBYESDISC 200MG N 021745 002 Nov 12 2013 Current OBYESDISC 300MG N 021745 003 Nov 12 2013 Current OBYES

TRAVOPROSTSOLUTIONDROPSOPHTHALMICIZBA

DISC NOVARTIS PHARMS 0003 N 204822 001 Jan 26 2016 Current OBYESCORPTRAVATAN

DISC ALCON PHARMS LTD 0004 N 021257 001 Nov 16 2011 Current OBYES

TRAZODONE HYDROCHLORIDETABLET EXTENDED RELEASEORALOLEPTRO

DISC ANGELINI PHARMA 150MG N 022411 001 Oct 30 2015 Current OBYESDISC 300MG N 022411 002 Oct 30 2015 Current OBYESTABLETORALDESYREL

DISC PRAGMA PHARMS LLC 50MG N 018207 001 Mar 11 2010 Current OBYESDISC 100MG N 018207 002 Mar 11 2010 Current OBYESDISC 150MG N 018207 003 Mar 11 2010 Current OBYESDISC 300MG N 018207 004 Mar 11 2010 Current OBYES

TRETINOINCAPSULEORALVESANOID

DISC ROCHE 10MG N 020438 001 Sep 14 2010 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 48: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 48 of 50

TRIAMCINOLONE ACETONIDECREAMTOPICALTRIAMCINOLONE ACETONIDE

RX MYLAN PHARMS INC 0025 N 011601 003 Nov 12 2013 Current OBYESRX 01 N 011601 006 Nov 12 2013 Current OBYESINJECTABLEINTRA-ARTICULAR INTRAMUSCULAR INTRAVITREALTRIVARIS

DISC ALLERGAN 8MG01ML (8MG01ML) N 022220 001 Jun 02 2016 Current OBYESLOTIONTOPICALKENALOG

DISC DELCOR ASSET CORP 0025 A 084343 001 Jun 06 2016 Current OBYESDISC 0025 N 011602 003 Mar 15 2016 Current OBYESDISC 01 A 084343 002 Jun 06 2016 Current OBYESDISC 01 N 011602 001 Mar 15 2016 Current OBYESOINTMENTTOPICALARISTOCORT

DISC ASTELLAS 05 A 080745 002 Aug 08 2016 Current OBYESARISTOCORT A

DISC ASTELLAS 05 A 080745 003 Aug 08 2016 Current OBYESKENALOG

DISC DELCOR ASSET CORP 05 A 083944 001 Aug 08 2016 Current OBYESPASTEDENTALKENALOG IN ORABASE

DISC DELCOR ASSET CORP 01 N 012097 001 Mar 11 2010 Current OBYES

TRIAMCINOLONE DIACETATEINJECTABLEINJECTIONARISTOCORT

DISC SANDOZ 40MGML N 012802 001 Jul 11 2007 Current OBYES

TRIFLUOPERAZINE HYDROCHLORIDECONCENTRATEORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 10MG BASEML N 011552 006 Jul 28 2011 Current OBYESINJECTABLEINJECTIONSTELAZINE

DISC GLAXOSMITHKLINE EQ 2MG BASEML N 011552 005 Jul 28 2011 Current OBYESTABLETORALSTELAZINE

DISC GLAXOSMITHKLINE EQ 1MG BASE N 011552 001 Jun 15 2009 Current OBYESDISC EQ 2MG BASE N 011552 002 Jun 15 2009 Current OBYESDISC EQ 5MG BASE N 011552 003 Jun 15 2009 Current OBYESDISC EQ 10MG BASE N 011552 004 Jun 15 2009 Current OBYES

TRIHEXYPHENIDYL HYDROCHLORIDETABLETORALARTANE

DISC LEDERLE 2MG N 006773 005 May 23 2007 Current OBYESDISC 5MG N 006773 003 May 23 2007 Current OBYES

TRIMETHOPRIMTABLETORALTRIMETHOPRIM

DISC TEVA 200MG A 071259 001 Feb 18 2014 Current OBYES

TROSPIUM CHLORIDECAPSULE EXTENDED RELEASEORALSANCTURA XR

DISC ALLERGAN 60MG N 022103 001 Dec 04 2015 Current OBYESTABLETORALSANCTURA

DISC ALLERGAN 20MG N 021595 001 Dec 04 2015 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 49: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 49 of 50

UNOPROSTONE ISOPROPYLSOLUTIONDROPSOPHTHALMICRESCULA

DISC SUCAMPO PHARMA LLC 015 N 021214 001 Sep 06 2016 Current OBYES

VALPROIC ACIDCAPSULE DELAYED RELEASEORALSTAVZOR

DISC BIONPHARMA INC 125MG N 022152 001 Feb 18 2014 Current OBYESDISC 250MG N 022152 002 Feb 18 2014 Current OBYESDISC 500MG N 022152 003 Feb 18 2014 Current OBYES

VANCOMYCIN HYDROCHLORIDEINJECTABLEINJECTIONVANCOCIN HYDROCHLORIDE

DISC ANI PHARMS INC EQ 1GM BASEVIAL A 060180 002 Dec 17 2015 Current OBYESDISC EQ 1GM BASEVIAL A 062812 002 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062812 003 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 060180 001 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062812 001 Dec 17 2015 Current OBYES

VANCOLEDDISC WEST-WARD PHARMS EQ 1GM BASEVIAL A 062682 002 Dec 17 2015 Current OBYES

INTDISC EQ 2GM BASEVIAL A 062682 003 Dec 17 2015 Current OBYESDISC EQ 5GM BASEVIAL A 062682 004 Dec 17 2015 Current OBYESDISC EQ 10GM BASEVIAL A 062682 005 Dec 17 2015 Current OBYESDISC EQ 500MG BASEVIAL A 062682 001 Dec 17 2015 Current OBYES

VASOPRESSIN TANNATEINJECTABLEINJECTIONPITRESSIN TANNATE

DISC PARKE DAVIS 5PRESSOR UNITSML N 003402 001 May 18 2012 Current OBYES

VECURONIUM BROMIDEINJECTABLEINJECTIONNORCURON

DISC ORGANON USA INC 10MGVIAL N 018776 002 Sep 06 2016 Current OBYESDISC 20MGVIAL N 018776 003 Sep 06 2016 Current OBYES

VENLAFAXINE HYDROCHLORIDETABLETORALEFFEXOR

DISC WYETH PHARMS INC EQ 125MG BASE N 020151 001 Jan 26 2015 Current OBYESDISC EQ 25MG BASE N 020151 002 Jan 26 2015 Current OBYESDISC EQ 375MG BASE N 020151 006 Jan 26 2015 Current OBYESDISC EQ 50MG BASE N 020151 003 Jan 26 2015 Current OBYESDISC EQ 75MG BASE N 020151 004 Jan 26 2015 Current OBYESDISC EQ 100MG BASE N 020151 005 Jan 26 2015 Current OBYES

VERAPAMIL HYDROCHLORIDETABLET EXTENDED RELEASEORALCALAN SR

DISC PFIZER 180MG N 019152 002 Nov 08 2016 Current OBYES

ZIDOVUDINETABLETORALRETROVIR

DISC VIIV HLTHCARE 300MG N 020518 002 Nov 12 2013 Current OBYES

ZOLEDRONIC ACIDINJECTABLEIV (INFUSION)ZOMETA

DISC NOVARTIS EQ 4MG BASEVIAL N 021223 001 Apr 14 2009 Current OBYES

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published

Page 50: FR Notice Determination of Safety or Effectiveness List · Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List *See List Footnote . December

Approved Drug Product List - Orange Book FR Notice Determination of Safety or Effectiveness List

See List Footnote

December 2016 Page 50 of 50

Orange Book Approved Products Report Total 1064 Current Edition Footnote Count 1006

Annual Orange Book Preface 111 Discontinued Section

Those drug products in the Discontinued Section of the Orange Book in which a determination hasalready been made that the products were not withdrawn for safety or efficacy reasons haveldquoFederal Register determination that product was not discontinued or withdrawn for safety orefficacy reasonsrdquo following the product strength Those drug products are only reflective ofcitizen petitions determinations made since 1995 The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission of multiple citizen petitionsfor the same drug product FR notices no longer applicable are removed from the Annual Edition(ie there is a currently marketed Reference Listed Drug and no applicable patent orexclusivity) httpwwwfdagovcderogdOrangeBookFRSafetyorEffectivenessDeterminationsListpdflists products that have current and removed notices The list is updated quarterly Noticesissued during the year are added to the Electronic Orange Book Query in the month they becomeeffective

The report is sorted by Active Ingredient(s) Dosage FormRoute Trade Name Firm Name andPotency Included are Type (Rx OTC Discn) Application Number Product Number Federal RegisterNotice Date and YesNo denoting whether the Footnote is currently in the Annual Edition OrangeBook or has been added to the Electronic Orange Book Query since the last edition was published