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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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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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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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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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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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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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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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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
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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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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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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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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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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
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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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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
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
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
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
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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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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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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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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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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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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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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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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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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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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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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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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
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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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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
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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
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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
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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
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
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
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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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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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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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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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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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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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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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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
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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
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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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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
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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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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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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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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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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
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
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
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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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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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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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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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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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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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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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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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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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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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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
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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
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
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
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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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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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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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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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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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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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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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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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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
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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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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
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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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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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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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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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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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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
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
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
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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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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
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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
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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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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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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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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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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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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
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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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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
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
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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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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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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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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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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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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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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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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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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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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
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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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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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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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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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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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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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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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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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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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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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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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
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
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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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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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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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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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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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
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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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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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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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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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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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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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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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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
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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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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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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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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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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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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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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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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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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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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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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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
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
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
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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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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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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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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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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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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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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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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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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
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
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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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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
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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
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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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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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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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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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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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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
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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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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
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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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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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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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
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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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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
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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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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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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
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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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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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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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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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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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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
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
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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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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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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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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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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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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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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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
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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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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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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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
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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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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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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
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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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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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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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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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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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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
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
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
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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
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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
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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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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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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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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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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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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
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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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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
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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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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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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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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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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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
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
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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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
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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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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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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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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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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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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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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
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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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
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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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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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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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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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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
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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
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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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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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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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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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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
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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
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
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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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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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
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
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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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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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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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
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
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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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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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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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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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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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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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
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
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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
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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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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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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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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
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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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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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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
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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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
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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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
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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
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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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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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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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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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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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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
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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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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
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
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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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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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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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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
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
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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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
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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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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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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
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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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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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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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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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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
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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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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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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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
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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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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
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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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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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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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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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
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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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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
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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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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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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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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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
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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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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
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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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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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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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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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
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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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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
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)
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
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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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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
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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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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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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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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
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
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
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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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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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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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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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
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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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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
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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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
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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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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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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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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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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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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
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
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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
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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
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
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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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
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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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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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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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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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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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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
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
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
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
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
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
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
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
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
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
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
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
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
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