180-Day Exclusivity Tracker

180-Day Exclusivity Tracker

LAST UPDATED: 3/14/2013

Drug Dosage Form Strength RLD Exclusivity Decision

Abacavir Sulfate Tablets 300 mg ZIAGEN 1/28/2009 6/18/2012

Tablets EPZICOM 9/27/2007Tentative Approval(s) Granted

Tablets TRIZIVIR 3/22/2011

Acarbose Tablets PRECOSE 3/22/2005 5/7/2008

Acetaminophen Injection OFIRMEV 4/7/2011

Acetaminophen 650 mg TYLENOL 2/25/2000

Tablets ULTRACET 4/21/2005

Tablets EXCEDRIN (Migraine) 11/26/2001

Exclusivity Granted (Pre-MMA)

Date of Submission

ANDA Approval Date

Approval Letter

ANDA No. 091294Exclusivity Granted (Expiration 12/16/2012)

Abacavir Sulfate/ Lamivudine

600 mg; 300 mg

Abacavir sulfate, Lamivudine and Zidovudine

300 mg/150 mg/300 mg

25 mg, 50 mg & 100 mg

ANDA No. 077532

Exclusivity Forfeited - Failure to Market (FDC Act § 505(j)(5)(D)(i)(I)) FDA Letter Decision

1000 mg/100 mL (10 mg/mL)

Extended-release Tablets

Prior to 12/8/2003

ANDA No. 075077

Exclusivity Granted (Pre-MMA) (Expiration 11/12/2000)

Acetaminophen/Tramadol Hydrochloride

325 mg/37.5 mg

Prior to 12/8/2003

ANDA No. 076475


Acetaminophen/Aspirin/Caffeine

250 mg/250 mg/65 mg

Prior to 12/8/2003

ANDA No. 075794

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091294s000ltr.pdf


http://www.regulations.gov/#!documentDetail;D=FDA-2007-N-0445-0026

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75077ltr.pdf


http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75794apdF.pdf

Drug Dosage Form Strength RLD Exclusivity DecisionDate of

SubmissionANDA Approval

DateApproval

Letter

Acetylcysteine Injection ACETADOTE 11/7/2012

Acyclovir Sodium Injection ZOVIRAX

No Exclusivity Granted (Pre-MMA)

Adapalene Topical Gel 0.30% DIFFERIN 9/15/2009 6/14/2012Exclusivity Granted

Gel 0.1%/2.5% EPIDUO 12/30/2011

Adefovir Dipivoxil Tablets 10 mg HEPSERA 6/8/2010

Adenosine Injection ADENOSCAN 4/16/2005

Albuterol Sulfate Oral Syrup VENTOLIN

Albuterol Sulfate VOLMAX 9/30/2002


Albuterol Sulfate Inhalation Solution 0.021% ACCUNEB 10/19/2005 9/25/2007Exclusivity Granted

Albuterol Sulfate Inhalation Solution 0.042% ACCUNEB 6/28/2004Exclusivity Granted (Pre-MMA)

Inhalation Solution DUONEB 12/21/2006

Albuterol Sulfate Inhalation Aerosol PRO-AIR HFA 5/18/2012

6 gm/30 mL (200mg/mL)

After 12/8/2003

ANDA No. 200644

Exclusivity Granted (Expiration 5/29/2013)

50 mg/mL, 10 mL and 20 mL vials

Prior to 12/8/2003

ANDA No. 200298

Adapalene and Benzoyl Peroxide


2 mg(base)/5 mL

Prior to 12/8/2003


4 mg and 8 mg Prior to

12/8/2003ANDA No. 076130

ANDA No. 077772

Prior to 12/8/2003

ANDA No. 076355

Albuterol Sulfate/ Ipratropium Bromide

0.083%/0.017%

Prior to 12/8/2003

ANDA No. 076867


0.09 mg base per actuation

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076130_ORIGINAL%20APPROVAL_PACKAGE.pdf




DateApproval

Letter

Alendronate Sodium Oral Solution 70 mg/75 mL FOSAMAX 9/7/2007

Alendronate Sodium Tablets FOSAMAX

2/6/2008

2/6/2008

Tablets FOSAMAX PLUS D 11/20/2007

Alfuzosin Hydrochloride 10 mg UROXATRAL 6/12/2007

7/18/2011

7/18/2011

7/18/2011

7/18/2011

7/18/2011

Almotriptan Malate Tablets AXERT 12/8/2005

Tentative Approval(s) Granted

5 mg, 10 mg, 35 mg, 40 mg and 70 mg

Prior to 12/8/2003

ANDA No. 075710

Exclusivity Granted (Pre-MMA) (Expiration 8/4/2008) (Sole Exclusivity - 5 mg, 10 mg, 35 mg, and 40 mg ; Shared Exclusivity - 70 mg)

ANDA No. 076184

Exclusivity Granted (Pre-MMA); (Expiration 8/4/2008) (Shared Exclusivity on 70 mg strength)

Alendronate Sodium and Cholecalciferol

70 mg/2800 IU and 70 mg/5600 IU


ANDA No. 079013

Exclusivity Granted (Shared) (Expiration 1/14/2012)

ANDA No. 079014


ANDA No. 079054


ANDA No. 079056


ANDA No. 079057


6.25 mg and 12.5 mg










DateApproval

Letter

Alosetron Hydrochloride Tablets LOTRONEX 12/2/2010

Alprazolam NIRAVAM 12/27/2005 1/9/2009

Alprazolam Tablets XANAX

Amifostine For Injection 500 mg/vial ETHYOL 4/16/2004 3/14/2008

Amlodipine Besylate Tablets NORVASC 10/3/2005

Tablets CADUET 9/17/2009

Tablets 2.5 mg/40 mg CADUET 9/17/2009

0.5 mg and 1 mg

Orally Disintegrating Tablets

0.25 mg, 0.5 mg, 1 mg and 2 mg

ANDA No. 078088


0.25 mg, 0.5 mg, 1 mg and 2 mg

Prior to 12/8/2003

ANDA No. 077126


2.5 mg, 5 mg and 10 mg

Prior to 12/8/2003

ANDA No. 076418

Exclusivity Granted (Pre-MMA) (Expiration 3/25/2007; Patent Expiration)

FDA Letter Decision 1



Amlodipine Besylate and Atorvastatin Calcium

2.5 mg/10 mg, 2.5 mg/20 mg and 10 mg/40 mg








DateApproval

Letter

Tablets CADUET 12/29/2006

Tablets 5 mg/80 mg CADUET 4/7/2009

Capsules LOTREL 6/9/2004 5/18/2007

Capsules LOTREL 11/17/2006 7/29/2010

Tablets AZOR 2/11/2008


Tablets AZOR 3/31/2008


Tablets 5 mg/160 mg EXFORGE 10/22/2007





5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg and 10 mg/80 mg


Amlodipine Besylate and Benazepril Hydrochloride

2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg

ANDA No. 077179


Amlodipine Besylate and Benazepril Hydrochloride

5 mg/40 mg and 10 mg/40 mg

ANDA No. 078381


Amlodipine Besylate and Olmesartan Medoxomil


Amlodipine Besylate and Olmesartan Medoxomil


Amlodipine Besylate and Valsartan





DateApproval

Letter





Tablets EXFORGE HCT 9/14/2009 9/25/2012

Tablets EXFORGE HCT 10/22/2009 9/25/2012

Exclusivity Granted

AUGMENTIN XR 1/21/2009 4/21/2010

Exclusivity Granted

Aprepitant Capsule EMEND 11/3/2008 9/24/2012

Arformoterol Tartrate Inhalation Solution BROVANA 10/1/2009

Argatroban Injection ARGATROBAN 9/24/2007


Injection ARGATROBAN 12/16/2011



Amlodipine, Hydrochlorothiazide and Valsartan

5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg

ANDA No. 200435

Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV))

Amlodipine, Hydrochlorothiazide and Valsartan

10 mg/12.5 mg/160 mg

ANDA No. 200435

Amoxicillin and Clavulanate Potassium


1000 mg/62.5 mg

ANDA No. 090227

40 mg, 80 mg and 125 mg

ANDA No. 090999

Eq. 0.015 mg base/2 mL

100 mg/mL, 2.5 mL vials

Argatroban in Sodium Chloride

1 mg/mL, 50 mL vials

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200435Orig1s000ltr.pdf





DateApproval

Letter

Aripiprazole Oral Solution 1 mg/mL ABILIFY 12/20/2007

Aripiprazole Tablets ABILIFY 11/15/2006

Aripiprazole ABILIFY 11/15/2006


Armodafinil Tablets NUVIGIL 7/24/2009 6/1/2012

Exclusivity Granted

Armodafinil Tablets 100 mg NUVIGIL 9/8/2009


Armodafinil Tablets 200 mg NUVIGIL 9/3/2009


Aspirin and Dipyridamole AGGRENOX 2/1/2007 8/14/2009

Atazanavir Sulfate Capsules REYATAZ 3/19/2010


Atazanavir Sulfate Capsules 200 mg REYATAZ 2/16/2010


Atazanavir Sulfate Capsules 300 mg REYATAZ 7/20/2009


2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg


10 mg, 15 mg, 20 mg and 30 mg

50 mg, 150 mg and 250 mg

ANDA No. 200043

Extended-release Capsules

25 mg and 200 mg

ANDA No. 078804

Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))

100 mg and 150 mg





DateApproval

Letter

Atenolol Tablets TENORMIN

Atenolol/ Chlorthalidone Tablets TENORETIC

Atovaquone Oral Suspension 750 mg/5 mL MEPRON 10/20/2009

Tablets MALARONE 9/14/2010

Tablets MALARONE 4/3/2009 1/12/2011

Capsules STRATTERA 5/29/2007

8/30/2010

Exclusivity Granted

8/30/2010

Exclusivity Granted

8/30/2010

9/13/2010

Exclusivity Granted

9/16/2010

Exclusivity Granted

25 mg, 50 mg and 100 mg

Prior to 12/8/2003

50 mg/25 mg and 100 mg/25 mg

Prior to 12/8/2003

Atovaquone and Proguanil Hydrochloride

62.5 mg/25 mg

Atovaquone and Proguanil Hydrochloride

250 mg/100 mg

ANDA No. 091211


Atomoxetine Hydrochloride

10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg

ANDA No. 079020

ANDA No. 079021

ANDA No. 078940

Exclusivity Forfeited (Failure to Obtain Tentative Approval in 30 Months - FDC Act § 505(j)(5)(D)(i)(IV))

ANDA No. 079016

ANDA No. 079017






DateApproval

Letter

Capsules STRATTERA 5/29/2007

9/13/2010

Exclusivity Granted

10/1/2010

Exclusivity Granted

Atorvastatin Calcium Tablets LIPITOR 11/30/2011

Azelaic Acid Gel 15% FINACEA 7/27/2012

Azelastine Hydrochloride Nasal Spray ASTELIN 11/14/2005 4/30/2009

Azelastine Hydrochloride Nasal Spray ASTEPRO 12/15/2011


Azelastine Hydrochloride 0.05% OPTIVAR 12/13/2006 8/3/2009

Azithromycin For Injection 500 mg/vial ZITHROMAX 6/17/2011

Azithromycin 1.00% AZASITE 3/3/2011

Azithromycin Injection ZITHROMAX

3/24/2009

Atomoxetine Hydrochloride

10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg

ANDA No. 079018

ANDA No. 079022

10 mg, 20 mg, 40 mg and 80 mg

Prior to 12/8/2003

ANDA No. 076477


0.125 mg base/spray

ANDA No. 077954


205.5 mcg/spray

Ophthalmic Solution ANDA No.

078621


Ophthalmic Solution

500 mg base/vial

On or After 12/8/2003

ANDA No. 065506






DateApproval

LetterAzithromycin Injection ZITHROMAX

6/26/2009

500 mg base/vial


ANDA No. 065500



Drug Dosage Form Strength RLD

Betamethasone Valerate Foam 0.12% LUXIQ 8/10/2007 11/26/2012

Betaxolol 0.5%(base) BETOPTIC

Bexarotene Capsules 75 mg TARGRETIN 6/6/2011

Bimatoprost 0.01% LUMIGAN 4/5/2011

Bimatoprost 0.03% LUMIGAN 12/22/2008

Bimatoprost Topical Solution 0.03% LATISSE 5/3/2010

Bivalirudin For Injection 250 mg/vial ANGIOMAX 9/1/2009

Bortezomib For Injection 3.5 mg/vial VELCADE 11/20/2008

Brimonidine Tartrate 0.10% ALPHAGAN P 12/20/2006

Brimonidine Tartrate 0.15% ALPHAGAN P 11/3/2006

Brimonidine Tartrate 0.20% ALPHAGAN 5/28/2003

Ophthalmic Solution 0.2%/0.5% COMBIGAN 11/21/2008

Budesonide 3 mg ENTOCORT EC 2/1/2008 5/16/2011

Date of Submission

ANDA Approval Date

Approval Letter

ANDA No. 078337

Ophthalmic Solution Prior to

12/8/2003

Ophthalmic Solution

Ophthalmic Solution

Ophthalmic Solution

Ophthalmic Solution


12/8/2003ANDA No.

076260

Brimonidine Tartrate and Timolol Maleate

Enteric Coated Capsules

ANDA No. 090410


Drug Dosage Form Strength RLDDate of


DateApproval

Letter

Budesonide Nasal Spray RHINOCORT 5/14/2007

Budesonide 9/15/2005 11/18/2008

Budesonide 1 mg/2 mL 5/28/2010

174 mg APLENZIN 9/28/2009

348 mg APLENZIN 9/24/2009

522 mg APLENZIN 12/24/2009

WELLBUTRIN SR

12/3/2004

150 mg ZYBAN

WELLBUTRIN XL

9/21/2004 12/14/2006

12/15/2006

0.032 mg (32 mcg)/spray

Inhalation Suspension

0.25 mg/2 mL and 0.5 mg/2 mL

PULMICORT RESPULES

ANDA No. 077519

Inhalation Suspension

PULMICORT RESPULES

Bupropion Hydrobromide Extended-release Tablets



Bupropion Hydrochloride Extended-release Tablets

100 mg, 150 mg and 200 mg

Prior to 12/8/2003

ANDA No. 076711


Prior to 12/8/2003


150 mg and 300 mg

ANDA No. 077284


ANDA No. 077415



http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077415TAltr.pdf



DateApproval

Letter

Tablets WELLBUTRIN

Buspirone Hydrochloride Tablets BUSPAR

3/28/2001

3/28/2001

3/28/2001

6/28/2001

Butoconazole Nitrate Vaginal Cream 2% GYNAZOLE-1 12/23/2009 5/18/2012

Butorphanol Tartrate Nasal Spray 10 mg/mL STADOL NS

Bupropion Hydrochloride 75 mg and 100 mg

Prior to 12/8/2003

5 mg, 7.5 mg, 10 mg, 15 mg and 30 mg

Prior to 12/8/2003

ANDA No. 074253

ANDA No. 075272

ANDA No. 075467

ANDA No. 076008

ANDA No. 200923

Prior to 12/8/2003

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75253ltr&TA.pdf





DateApproval

Letter


Exclusivity Decision



Exclusivity Presumably Granted


Exclusivity Forfeited (Application Withdrawn (FDC Act § 505(j)(5)(D)(i)(II))



No Exclusivity Granted

Exclusivity Relinquished (Pre-MMA)

Exclusivity Presumably Selectively Waived (Pre-MMA) (100 mg)

Exclusivity Relinquished (Pre-MMA) (150 mg)

See ANDA No. 075932

Exclusivity Granted (Pre-MMA) (200 mg)

Exclusivity Granted (Expiration 6/12/2007; 300 mg; Exclusivity Selectively Waived) (Expired 11/26/2008; 150 mg)

Exclusivity Granted (Expiration 6/12/2007; 300 mg; Exclusivity Selectively Waived)

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75932s001s002ltr.pdf


No Exclusivity Presumably Granted (Pre-MMA)

Exclusivity Granted (Pre-MMA) (Expiration 9/26/2001; 5 mg & 10 mg)

Exclusivity Granted (Pre-MMA) (Expiration 9/24/2001; 15 mg)

Exclusivity Granted (Pre-MMA) (Expiration 9/26/2001; 7.5 mg strength)





Calcipotriene Topical Cream 0.005% DOVONEX 12/2/2009

Calcipotriene Topical Solution 0.005% DOVONEX 5/19/2006 5/6/2008

Ointment TACLONEX 3/31/2010 1/14/2013

Calcitonin-Salmon Nasal Spray 200 IU/spray MIACALCIN 11/17/2008

Nasal Spray 200 IU/spray FORTICAL 3/29/2006

Calcitriol Injection CALCIJEX

2/20/2003

3/31/2003

12/31/2002

Calcium Acetate Capsules PHOSLO 5/31/2005 2/26/2008

Date of Submission

ANDA Approval Date

Approval Letter

ANDA No. 078305

Calcipotriene and Betamethasone Dipropionate

0.005%/0.064%

ANDA No. 201615

Prior to 12/8/2003

ANDA No. 076396

Calcitonin-Salmon (Recombinant)

1 mcg/mL and 2 mcg/mL, 1 mL vials

Prior to 12/8/2003

ANDA No. 075766

ANDA No. 075823

ANDA No. 075836

EQ 169 mg calcium

ANDA No. 077728






DateApproval

Letter

Chewable Tablets PEPCID COMPLETE 11/1/2004 2/6/2008

Candesartan Cilexetil Tablets ATACAND 12/22/2006

Tablets ATACAND HCT 6/25/2008 12/4/2012

Tablets 32 mg/25 mg ATACAND HCT 3/6/2009 12/4/2012

Capecitabine Tablets XELODA 11/10/2008

Captopril Tablets CAPOTEN

Carbamazepine CARBATROL 2/2/2006

Carbamazepine EQUETRO 8/21/2007

Carbamazepine 300 mg CARBATROL 5/20/2011

Carbamazepine 100 mg TEGRETOL-XR 12/30/2005 3/31/2009

Carbamazepine TEGRETOL-XR

Calcium Carbonate/ Famotidine/ Magnesium Hydroxide

800 mg/ 10 mg/ 165 mg (OTC)

ANDA No. 077355

4 mg, 8 mg, 16 mg and 32 mg

Candesartan Cilexetil and Hydrochlorothiazide

16 mg/12.5 mg and 32 mg/12.5 mg

ANDA No. 090704

Candesartan Cilexetil and Hydrochlorothiazide

ANDA No. 090704

150 mg and 500 mg

12.5 mg, 25 mg, 50 mg, and 100 mg

Prior to 12/8/2003


100 mg and 200 mg


200 mg and 300 mg


Prior to 12/8/2003

ANDA No. 076697


ANDA No. 078115


200 mg and 400 mg

Prior to 12/8/2003








DateApproval

Letter

Tablets STALEVO 50 8/5/2008

Tablets 5/19/2009

Tablets 6/29/2007

Tablets STALEVO 200 8/28/2008

Carbidopa/ Levodopa SINEMET CR

Carboplatin For Injection PARAPLATIN

Carboplatin Injection PARAPLATIN

Carisoprodol/ Aspirin Tablets SOMA COMPOUND

Tablets

Carvedilol Tablets COREG

Carvedilol Phosphate COREG CR 3/18/2008

Carbidopa, Levodopa and Entacapone

12.5 mg, 50 mg and 200 mg


18.75 mg/75 mg/200 mg and 31.25 mg/125 mg/200 mg

STALEVO 75 AND STALEVO 125


25/100/200 mg and 37.5/150/200 mg

STALEVO 100 AND STALEVO 150


50 mg/200 mg/200 mg


25 mg/100 mg and 50 mg/200 mg

Prior to 12/8/2003

50 mg/vial, 150 mg/vial and 450 mg/vial

Prior to 12/8/2003


Prior to 12/8/2003

200 mg/ 325 mg

Prior to 12/8/2003

Carisoprodol/ Aspirin/ Codeine

200 mg/ 325 mg/ 16 mg

SOMA COMPOUND WITH CODEINE

Prior to 12/8/2003

3.125 mg, 6.25 mg, 12.5 mg and 25 mg

Prior to 12/8/2003


10 mg and 20 mg



DateApproval

Letter

Carvedilol Phosphate 40 mg COREG CR 12/21/2007

Carvedilol Phosphate 80 mg COREG CR 11/19/2007

Caspofungin Acetate For Injection CANCIDAS 6/26/2009

Celecoxib Capsules 50 mg CELEBREX 3/21/2008

Celecoxib Capsules CELEBREX

Cetirizine Hydrochloride Syrup 5 mg/5 mL ZYRTEC 3/19/2007

Cetirizine Hydrochloride Chewable Tablets ZYRTEC 3/25/2005 1/11/2008

5 mg/120 mg ZYRTEC-D 6/2/2004 2/25/2008

Capsules 30 mg EVOXAC 2/27/2009 8/25/2011

Chlorhexidine Gluconate 4% HIBICLENS

TUSSIONEX 9/10/2004

Ciclesonide Nasal Spray 250 mcg OMNARIS 2/13/2012



50 mg/vial and 70 mg/vial

100 mg, 200 mg and 400 mg

Likely Pre-MMA

5 mg and 10 mg (OTC)

ANDA No. 077631

Cetirizine Hydrochloride and Pseudoephedrine


ANDA No. 077170

Cevimeline Hydrochloride

ANDA No. 091260

Scrub brush/sponge

Prior to 12/8/2003

Chlorpheniramine Polistirex and Hydrocodone Polistirex




http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077170_s000ltr.pdf




DateApproval

Letter

Ciclopirox Gel 0.77% LOPROX 5/10/2006 1/7/2009

Tablets SENSIPAR 3/10/2008

Ciprofloxacin Oral Suspension CIPRO 10/16/2009

Tablets CIPRO 6/9/2004

500 mg CIPRO XR 11/30/2010

1000 mg CIPRO XR 11/30/2010

Cisatracurium Besylate NIMBEX 8/12/2009

Cisatracurium Besylate NIMBEX 8/4/2009

Cisplatin Injection PLATINOL-AQ 7/16/1999

Cisplatin For Injection PLATINOL

ANDA No. 078266

Cinacalcet Hydrochloride 30 mg, 60 mg and 90 mg

250 mg/5 mL and 500 mg/ 5 mL

Ciprofloxacin Hydrochloride

100 mg, 250 mg, 500 mg and 750 mg

Prior to 12/8/2003

ANDA No. 075593




ANDA No. 077417




ANDA No. 077809

(multi-dose) Injection

2 mg/mL, 10 mL vial

(preserve free) Injection

2 mg/mL, 5 mL vial and 10 mg/mL, 20 mL vial

1 mg/mL, 10 mL, 50 mL, 100 mL and 200 mL vials

Prior to 12/8/2003

ANDA No. 074735


Prior to 12/8/2003





DateApproval

Letter

Clarithromycin 500 mg BIAXIN XL 12/6/2010

Clindamycin Phosphate Foam 1% EVOCLIN 3/31/2010

Gel 1% / 5% DUAC 12/11/2008

Gel 1.2%/0.025% ZIANA 12/17/2010 6/26/2012

Clobetasol Propionate Emulsion Foam 0.05% OLUX-E 2/25/2010 8/14/2012

Clobetasol Propionate Topical Foam 0.05% OLUX 6/27/2005 3/10/2008

Clobetasol Propionate Lotion 0.05% CLOBEX 3/27/2006 12/4/2008

Clobetasol Propionate Spray 0.05% CLOBEX 9/29/2008 6/16/2011

Clobetasol Propionate Topical Shampoo 0.05% CLOBEX 1/9/2008 6/7/2011

Clofarabine Injection CLOLAR 2/23/2012

Clonidine hydrochloride KAPVAY 3/4/2011

Clonidine hydrochloride JENLOGA 3/4/2011

Extended-release Tablet

PIV received prior to

2/5/2009ANDA No. 090785

Clindamycin Phosphate and Benzoyl Peroxide

Clindamycin Phosphate and Tretinoin

ANDA No. 090979

ANDA No. 201402

ANDA No. 077763

ANDA No. 078223

ANDA No. 090898

ANDA No. 078854

1 mg/mL, 20 mL vial


0.1 mg and 0.2 mg


0.1 mg and 0.2 mg








DateApproval

Letter

Clonidine Hydrochloride CATAPRES-TTS

Clopidogrel Bisulfate Tablets 75 mg PLAVIX

5/17/2012

Clopidogrel Bisulfate Tablets 300 mg PLAVIX 3/4/2009 5/17/2012

Clozapine 12.5 mg FAZACLO 6/5/2008

Clozapine FAZACLO 4/28/2008

Clozapine 150 mg FAZACLO 4/8/2011

Clozapine 200 mg FAZACLO 4/18/2011

Colchicine Tablets 0.6 mg COLCRYS 12/23/2011

WELCHOL 4/9/2010

Transdermal System

0.1 mg/day, 0.2 mg/day, and 0.3 mg/day

Prior to 12/8/2003

Prior to 12/8/2003

1/20/2006 (6/22/2009 -

Converted to a Tentative Approval)

ANDA No. 076274

ANDA No. 077665

ANDA No. 091023



25 mg and 100 mg



Colesevelam Hydrochloride

Powder for Oral Suspension

1.875 g/Packet and 3.75 g/Packet

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76274APltr.pdf





DateApproval

Letter

Tablets 625 mg WELCHOL 7/1/2009

Colestipol Hydrochloride Tablets 1 g COLESTID 8/23/2005 10/24/2006

Tablets CENESTIN 3/19/2009

Tablets 1.25 mg CENESTIN 11/3/2008

Tablets 0.625 mg CENESTIN 3/2/2009

Conjugated Estrogens Tablets PREMARIN

Tablets 10 mg FLEXERIL 2/29/1988

AMRIX 8/11/2008 4/18/2011

Cyclophosphamide For Injection CYTOXAN

Colesevelam Hydrochloride

ANDA No. 077510

Conjugated Estrogen (Synthetic A)

0.3 mg, 0.45 mg and 0.9 mg



0.3 mg and 0.625 mg

Prior to 12/8/2003

Cyclobenzaprine Hydrochloride

Prior to 12/8/2003

ANDA No. 071611

Cyclobenzaprine Hydrochloride

Extended-release Capsule

15 mg and 30 mg

ANDA No. 090738

100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial and 2 g/vial

Prior to 12/8/2003




DateApproval

Letter



Exclusivity Granted

Exclusivity Granted



Exclusivity Granted (Pre-MMA; Shared) (Expiration 9/17/2003)





Exclusivity Granted

Exclusivity Forfeited

Presumably No Exclusivity Granted (Pre-MMA)


Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))

FDA Letter Decsion



FDA Letter Decsion


http://www.hpm.com/pdf/blog/CarbaER180ltr.pdf

http://www.hpm.com/pdf/blog/CarbaER180ltr.pdf




Exclusivity Granted (Exclusivity Believed to Have Been Triggered By Authorized Generic Marketing)









No Exclusivity Granted (Presumably Forfeited)





Exclusivity Granted


Exclusivity Granted

Exclusivity Granted

Exclusivity Granted (Pre-MMA) (Expiration 2/5/2005) (Only with respect to 100 mg; FDA determined 250 mg, 500 mg and 750 mg "are ineligible for 180-day exclusivity")

Exclusivity Granted - (Expiration 5/15/2000)

FDA Decision - Docket No. FDA-1999-P-0058 (formerly Docket No. 1999P-1271) (Aug. 2, 1999))


Exclusivity Granted

Exclusivity Granted (QI Act) (Expiration 9/27/2010)





Exclusivity Granted (Expiration 6/30/2012) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV))


No Exclusivity Presumably Granted







No ANDAs for this drug; see FDA Decision

Exclusivity Granted (Pre-MMA) - (Expiration 11/15/1989)


http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm169045.htm


Drug Dosage Form Strength RLD Exclusivity Decision

Daptomycin For Injection 500 mg/vial CUBICIN 11/19/2008

ENABLEX 12/22/2008Tentative Approval(s) Granted

Darunavir Ethanolate Tablets PREZISTAS 6/23/2010

Dasatinib Tablets SPRYCEL 6/17/2011

Dasatinib Tablets SPRYCEL 6/28/2010

Deferasirox Tablets EXJADE 10/28/2011

Desflurane Inhalation 99.90% SUPRANE 9/11/2008

Desloratadine Tablets 5 mg CLARINEX 6/21/2006

Desloratadine CLARINEX 6/21/2006

Date of Submission

ANDA Approval Date

Approval Letter

Darifenacin Hydrobromide


7.5 mg and 15 mg

75 mg, 150 mg, 300 mg, 400 mg and 600 mg

80 mg and 140 mg

20 mg, 50 mg, 70 mg and 100 mg

125 mg, 250 mg, and 500 mg

Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV)); All First Applicants Forfeited (Mass Forfeiture)

See ANDA No. 078357


2.5 mg and 5 mg


See ANDA No. 078367

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/78357Ltr.pdf




DateApproval

Letter

Desloratadine Oral Solution 0.5 mg/mL CLARINEX SYRUP 5/8/2008

6/1/2007

5 mg/240 mg 6/21/2006

Desmopressin Acetate Injection DDAVP

Desmopressin Acetate Nasal Spray 0.01% DDAVPNo Exclusivity Granted (Pre-MMA)

Desmopressin Acetate Tablets DDAVP 7/1/2005

Tablets MIRCETTE 4/5/2002

Desonide Gel 0.05% DESONATE 12/1/2010

PRISTIQ 2/29/2012

Dexlansoprazole 30 mg DEXILANT 11/30/2010

Desloratadine and Pseudoephedrine Sulfate


2.5 mg/120 mg CLARINEX-D 24

HOUR

Desloratadine and Pseudoephedrine Sulfate


CLARINEX-D 24 HOUR

Exclusivity Forfeited - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV)); All First Applicants Forfeited (Mass Forfeiture)

See ANDA No. 078366

4 mcg/mL, 1 mL and 10 mL vials

Prior to 12/8/2003

Prior to 12/8/2003

0.1 mg and 0.2 mg

Prior to 12/8/2003

ANDA No. 076470


Desogestrel; Ethinyl Estradiol

0.15mg/ 0.02 mg and 0.01 mg

Prior to 12/8/2003

ANDA No. 075863


Desvenlafaxine Succinate


50 mg and 100 mg

Delayed-release Capsule



http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75863.ap.pdf



DateApproval

Letter

Dexlansoprazole 60 mg DEXILANT 8/25/2010

Dexmedetomidine Injection 100 mcg/mL PRECEDEX 4/8/2009Tentative Approval(s) Granted

Tablets 2.5 mg FOCALIN 7/27/2004 1/29/2007

Tablets FOCALIN 5/27/2004 1/29/2007

15 mg FOCALIN XR 5/14/2007

FOCALIN XR 3/30/2007

30 mg FOCALIN XR 12/15/2010Tentative Approval(s) Granted

40 mg FOCALIN XR 12/20/2010

Dexmethylphenidate 25 mg FOCALIN XR 9/30/2011

Dexmethylphenidate 35 mg FOCALIN XR 9/29/2011

Dexrazoxane For Injection ZINECARD 9/28/2004

ADDERALL XR

8/25/2004

Delayed-release Capsule

Dexmethylphenidate Hydrochloride

ANDA No. 077107



5 mg and 10 mg

ANDA No. 077107






5 mg, 10 mg and 20 mg



Dexmethyphenidate Hydrochloride


Extended-release capsules

Extended-release capsules

250 mg/vial, and 500 mg/vial

Prior to 12/8/2003

ANDA No. 076068

Exclusivity Granted (Pre-MMA) (Expiration 8/27/2005; 250 mg/vial) (Expiration 10/19/2005; 500 mg/vial)

Dextroamphetamine saccharate; Amphetamine aspartate; Dextroamphetamine Sulfate; Amphetamine Sulfate



Prior to 12/8/2003

ANDA No. 076814

Exclusivity Granted (Expiration 8/4/2008; 5 mg)






DateApproval

LetterADDERALL XR

Tablets ADDERALL 30 11/18/2009

Tablets ADDERALL 2/11/2002

30 mg/5 mL DELSYM 1/12/2009 5/25/2012Exclusivity Granted

Capsules 20 mg/10 mg NUEDEXTA 3/7/2011

Diazepam Tablets VALIUM

Diazepam Rectal Gel DIASTAT 3/23/2004

Diazepam Rectal Gel DIASTAT ACUDIAL 12/8/2008




Prior to 12/8/2003

A period of 180-day exclusivity was triggered by the launch of an authorized generic.


5 mg, 10 mg, 20 mg, 30 mg


7.5 mg, 12.5 mg and 15 mg

Prior to 12/8/2003

ANDA No. 040422


Dextromethorphan Polistirex

Extended-release Suspension

ANDA No. 091135

Dextromethorphan Hydrobromide and Quinidine Sulfate


Prior to 12/8/2003

2.5 mg/0.5 mL, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL and 20 mg/4 mL

5 mg/mL, 4mL pre-filled syringe

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040422.PDF




DateApproval

Letter

Diazepam Rectal Gel DIASTAT ACUDIAL 12/23/2008

Diclofenac Potassium 50 mg CAMBIA 1/24/2011

Diclofenac Sodium Topical Gel 3% SOLARAZE 12/16/2009

Diclofenac Sodium Topical Solution 2% PENNSAID 7/11/2012

50 mg/0.2 mg ARTHROTEC 6/29/2009

75 mg/0.2 mg ARTHROTEC 11/28/2008

Didanosine VIDEX EC 6/1/2004 12/3/2004

Diltiazem Hydrochloride CARDIZEM SR

Diltiazem Hydrochloride DILACOR XR

Diltiazem Hydrochloride CARDIZEM CD 7/9/1998

Diltiazem Hydrochloride TIAZAC

4/10/2003


Oral Solution (Sachet)

Diclofenac Sodium and Misoprostol

Delayed-release Tablets


Diclofenac Sodium and Misoprostol



Delayed-release Capsules

200 mg, 250 mg and 400 mg

ANDA No. 077167



60 mg, 90 mg and 120 mg

Prior to 12/8/2003


120 mg, 180 mg and 240 mg

Prior to 12/8/2003


120 mg, 180 mg, 240 mg and 300 mg

Prior to 12/8/2003

ANDA No. 074752




Prior to 12/8/2003

ANDA No. 075401

Exclusivity Granted (Pre-MMA) (Sole exclusivity on 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg)



http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075401.pdf



DateApproval

LetterDiltiazem Hydrochloride TIAZAC

9/12/2006

Diltiazem Hydrochloride CARDIZEM LA 8/30/2005 3/15/2010

Exclusivity Granted

Diltiazem Hydrochloride 420 mg CARDIZEM LA 4/25/2005 3/15/2010Exclusivity Granted

Divalproex Sodium DEPAKOTE


Divalproex Sodium 250 mg DEPAKOTE ER 5/3/2004

Divalproex Sodium 500 mg DEPAKOTE ER 2/8/2005 1/29/2009

Docetaxel Injection TAXOTERE 6/30/2009

Donepezil Hydrochloride Tablets ARICEPT 11/26/2010

Donepezil Hydrochloride ARICEPT ODT 6/30/2010 11/25/2010

Doripenem Injection DORIBAX 10/12/2011



Prior to 12/8/2003

ANDA No. 076563

Exclusivity Granted (Pre-MMA) (Sole exclusivity the 420 mg)


120 mg, 180 mg, 240 mg, 300 mg and 360 mg

ANDA No. 077686


ANDA No. 077686


125 mg, 250 mg and 500 mg

Prior to 12/8/2003


ANDA No. 077143



ANDA No. 077567


40 mg/mL, 0.5 mL and 2 mL vials

5 mg and 10 mg

Prior to 12/8/2003

ANDA No. 076786

Exclusivity Granted (Pre-MMA) (Expiration 5/28/2011) (Originally Shared Exclusivity; later FDA determination that no shared exclusivity for non-mutually blocking Paragraph IV Certifications)

FDA Letter Decision


5 mg and 10 mg

ANDA No. 078388

Exclusivity Granted, Then Revoked - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))





http://www.fdalawblog.net/files/aricept---2010-09-27-tevas-ltr-to-the-court-re-factual-background-re-appeal.pdf




DateApproval

Letter

2% TRUSOPT 10/11/2005No Exclusivity Granted

2%/0.5% COSOPT 10/11/2005 10/28/2008

Doxazosin Mesylate Tablets CARDURANo Exclusivity Granted (Pre-MMA)

Doxepin Hydrochloride Tablets SILENOR 9/16/2010Tentative Approval(s) Granted

Doxercalciferol Capsules 1 mcg HECTOROL 2/12/2010Tentative Approval(s) Granted

Doxercalciferol Capsules HECTOROL 3/25/2009 9/23/2011

Doxercalciferol Injection HECTOROL 10/15/2007

Doxercalciferol Injection HECTOROL 12/28/2011

Doxycycline 40 mg ORACEA 12/11/2008 7/1/2010

Exclusivity Granted (QI Act)

Doxycycline Hyclate DORYX

12/28/2010

12/28/2010

Dorzolamide Hydrochloride

Ophthalmic Solution

Dorzolamide Hydrochloride and Timolol Maleate

Ophthalmic Solution ANDA No. 077847

Exclusivity Forfeited - Failure to Market (FDC Act § 505(j)(5)(D)(i)(I))

FDA Letter Decision

1 mg, 2 mg, 4 mg, and 8 mg

Prior to 12/8/2003

3 mg and 6 mg

0.5 mcg and 2.5 mcg

ANDA No. 091433Exclusivity Granted (0.5 mcg); Tentative Approval(s) Granted (2.5 mcg)

2 mcg/mL, 2 mL ampules

ANDA No. 090040

Tentative Approval(s) Granted; Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV))

FDA Citizen Petition Decision

2 mcg/mL, 1 mL in 2 mL vial


ANDA No. 090855


75 mg and 100 mg


2/5/2009

ANDA No. 090431

Exclusivity Granted (QI Act; Shared) (Expiration 6/28/2011) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV) & Citizen Petition exception)

ANDA No. 090505

Exclusivity Granted (QI Act; Shared) (Expiration 6/28/2011) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV) & Citizen Petition exception)




http://www.regulations.gov/#!documentDetail;D=FDA-2010-P-0632-0017





DateApproval

Letter

Doxycycline Hyclate 150 mg DORYX 12/19/2008

Tablets 0.5 mg/1 mg ANGELIQ 12/26/2007

Tablets 3 mg/0.02 mg YAZ 9/29/2006 3/30/2009

Exclusivity Granted

Tablets 3 mg/0.03 mg YASMIN 1/7/2005 5/9/2008

Tablets BEYAZ 11/21/2011

CYMBALTA 8/4/2008


40 mg CYMBALTA 5/10/2012

Dutasteride Capsules 0.5 mg AVODART 10/29/2007 12/21/2010

Capsule 0.5 mg/0.4 mg JALYN 10/26/2010



See ANDA No. 091052

Drospirenone and Estradiol

Drospirenone and Ethinyl Estradiol

ANDA No. 078515

Drospirenone and Ethinyl Estradiol

ANDA No. 077527

Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV)); FDA later determined that 180-day exclusivity was forfeited (FDC Act § 505(j)(5)(D)(i)(IV)) and approved ANDA No. 090081.

Drospirenone and Ethinyl Estradiol and Levomefolate

3 mg/0.02 mg/0.451 mg and 0.451 mg

Duloxetine Hydrochloride



Duloxetine Hydrochloride Delayed-release Capsules

ANDA No. 090095


Dutasteride and Tamsulosin Hydrochloride

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091052Orig1s000Approv.pdf






DateApproval

Letter



Efavirenz Tablets 600 mg SUSTIVA 4/9/2009

Tablets ATRIPLA 12/29/2008

Eletriptan Hydrobromide Tablets RELPAX 3/29/2010

Tablets TRUVADA 9/26/2008

Enalapril Maleate Tablets VASOTEC

Enoxaparin Sodium Injection LOVENOX

Enoxaparin Sodium Injection LOVENOX

Enoxaparin Sodium Injection LOVENOX 12/7/2006

Date of Submission

ANDA Approval Date

Approval Letter

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate

600 mg/200 mg/300 mg

20 mg and 40 mg

Emtricitabine and Tenofovir Disoproxil Fumarate

200 mg/300 mg

2.5 mg, 5 mg, 10 mg and 20 mg

Prior to 12/8/2003

100 mg/mL, 0.3 mL, 0.4 mL, 0.6 mL, 0.8 mL and 1 mL prefilled syringes

Prior to 12/8/2003

150 mg/mL, 0.6 mL, 0.8 mL and 1 mL prefilled syringes

Prior to 12/8/2003




DateApproval

Letter

Entacapone Tablets 200 mg COMTAN 4/11/2007

Entecavir Tablets BARACLUDE 6/14/2010

Epinastine Hydrochloride 0.05% ELESTAT 10/14/2008 3/14/2011

Epinephrine 7/20/2009

Eplerenone Tablets INSPRA 9/27/2006

7/30/2008

8/1/2008

Eprosartan Mesylate Tablets TEVETEN 5/10/2010 11/16/2011

Eptifibatide Injection INTEGRILIN 6/5/2009



Erlotinib Hydrochloride Tablets TARCEVA 11/18/2008

Escitalopram Oxalate Capsules 5 mg LEXAPRO 8/17/2005 7/31/2007

0.5 mg and 1 mg


Injection (Autoinjector)

0.15 mg/0.3 mL and 0.3 mg/0.3 mL

EPIPEN AND EPIPEN JR.

25 mg and 50 mg

ANDA No. 078482

ANDA No. 078510

400 mg and 600 mg

ANDA No. 202012

0.75 mg/mL, 100 mL vial

2 mg/mL, 10 mL vial

2 mg/mL, 100 mL vial

25 mg, 100 mg and 150 mg

ANDA No. 077660







DateApproval

Letter

Escitalopram Oxalate Capsules LEXAPRO 3/30/2005 7/31/2007

Escitalopram Oxalate Tablets LEXAPRO 3/14/2012

Esmolol Hydrochloride Injection BREVIBLOC 8/10/2004

NEXIUM 8/5/2005

Esomeprazole Sodium For Injection NEXIUM IV 11/23/2009

Estradiol VIVELLE DOT 4/27/2010

Estradiol CLIMARA 9/12/2005 7/20/2006

Estradiol CLIMARA 2/24/2000

Tablets PREFEST 4/29/2005

Tablets NATAZIA 10/22/2010

10 mg and 20 mg

ANDA No. 077660


Prior to 12/8/2003

ANDA No. 076765


Prior to 12/8/2003

ANDA No. 076323

Esomeprazole Magnesium


20 mg and 40 mg


Transdermal System

0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day

Transdermal System

0.0375 mg/day and 0.06 mg/day

ANDA No. 075182

Transdermal System

0.05 mg/day and 0.1 mg/day

Prior to 12/8/2003

ANDA No. 075182

Estradiol; Estradiol and Norgestimate

1 mg; 1 mg and 0.09 mg

Prior to 12/8/2003

ANDA No. 076812

Estradiol Valerate and Dienogest

3 mg; 2 mg/2 mg; 2 mg/3 mg; 1 mg




http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/75182%20s015s016_ltr.pdf



DateApproval

Letter

Eszopiclone Tablets LUNESTA 12/15/2008 5/21/2011

Etodolac LODINE XL

7/31/2000

7/31/2000

Ezetimibe Tablets 10 mg ZETIA 10/25/2006

Tablets VYTORIN 7/27/2009

1 mg, 2 mg and 3 mg

ANDA No. 091169


400 mg, 500 mg and 600 mg

Prior to 12/8/2003

ANDA No. 075665

ANDA No. 075696

Ezetimibe and Simvastatin

10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg


http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75665ltrTA.pdf








Exclusivity Expired (Court Decision; Pre-MMA)

Exclusivity Expired (Court Decision; Pre-MMA)

See ANDA No. 077857

See ANDA No. 077857









Exclusivity Granted (Suitability Petition - Docket No. 2004P-0247)



Exclusivity Presumably Granted (Pre-MMA)






Exclusivity Granted

Exclusivity Granted (Pre-MMA) (Sole Exclusivity on 500 mg & 600 mg; Expiration 2/13/2001)

Exclusivity Granted (Pre-MMA) (Sole Exclusivity on 400 mg strength; Expiration 2/4/2001)



Famciclovir Tablets FAMVIR 12/28/2004 8/24/2007

Famotidine Injection PEPCID



Famotidine Tablets 10 mg (OTC) PEPCID AC

5/31/2001

11/28/2001

Famotidine Tablets PEPCID

Famotidine 10 mg (OTC) 8/22/2003

Date of Submission

ANDA Approval Date

Approval Letter

125 mg, 250 mg and 500 mg

ANDA No. 077487

10 mg/mL, 2 mL vials; unpreserved

Prior to 12/8/2003

10 mg/mL, 4 mL and 20 mL vials; preserved

Prior to 12/8/2003

10 mg/mL, 50 mL vial, pharmacy bulk package; unpreserved

Prior to 12/8/2003

Prior to 12/8/2003

ANDA No. 075312

ANDA No. 075404

20 mg and 40 mg

Prior to 12/8/2003

Tablets (Chewable) PEPCID AC

(CHEWABLE)Prior to

12/8/2003ANDA No.

075715






DateApproval

Letter

Felodipine PLENDIL ER 11/2/2004

Fenofibrate Tablets FENOGLIDE 3/17/2010

Fenofibrate Capsules ANTARA 9/15/2008 3/1/2012

Fenofibrate Choline 45 mg TRILIPIX 9/2/2009

Fenofibrate Choline 135 mg TRILIPIX 9/1/2009

Fenofibrate Capsules TRICOR 4/9/2002

Fenofibrate Tablets 48 mg TRICOR 7/1/2008

Fenofibrate Tablets TRICOR

5/13/2005

10/31/2005

12/29/2005

Fenofibrate Tablets 145 mg TRICOR 10/19/2007



Prior to 12/8/2003

ANDA No. 075896

40 mg and 120 mg

43 mg and 130 mg

ANDA No. 090859



67 mg, 134 mg and 200 mg

Prior to 12/8/2003

ANDA No. 075753

54 mg, 107 mg and 160 mg

Prior to 12/8/2003

ANDA No. 076433

ANDA No. 076635

ANDA No. 076520


http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75753.ta.pdf




DateApproval

Letter

Fentanyl DURAGESIC

Fentanyl Citrate Buccal Tablets FENTORA 11/13/2007 1/7/2011

Fentanyl Citrate Lozenges 0.2 mg ACTIQ 10/29/2004



Fentanyl Citrate Lozenges ACTIQ 11/22/2004

Oral Suspension 30 mg/5 mL ALLEGRA 1/25/2010 7/25/2012

Capsules 60 mg ALLEGRA 7/13/2005

Tablets ALLEGRA

8/31/2005

Transdermal Extended-release Film

0.6 mg/24 hr, 1.2 mg/ 24 hr, 1.8 mg/ 24 hr and 2.4 mg/ 24 hr

Prior to 12/8/2003

11/21/2003 (6/22/2004 - Converted to a Tentative Approval)

ANDA No. 076258

(1/28/2005 - Converted Back to a Final Approval)

0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg

ANDA No. 079075

0.8 mg, 1.2 mg and 1.6 mg

Fexofenadine Hydrochloride

ANDA No. 201311


Prior to 12/8/2003

ANDA No. 076169


30 mg, 60 mg and 180 mg

Prior to 12/8/2003

ANDA No. 076191

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76-258.rescind.ltr.pdf







DateApproval

LetterTablets ALLEGRA

4/16/2007

60 mg/120 mg ALLEGRA-D

4/14/2005

11/12/2010

6/6/2007 3/16/2010

Finasteride Tablets 1 mg PROPECIA 7/28/2006

Finasteride Tablets 5 mg PROSCAR 6/19/2006

Flecainide Acetate Tablets TAMBOCOR 7/31/2001

Fluconazole

Fluconazole Tablets DIFLUCAN

Flunisolide Nasal Solution 0.025% NASALIDE

Fluocinonide Cream 0.10% VANOS 1/31/2008


30 mg, 60 mg and 180 mg

Prior to 12/8/2003

ANDA No. 077081

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride


Prior to 12/8/2003

ANDA No. 076236

ANDA No. 076298

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride


180 mg/240 mg

ALLEGRA-D 24 HOUR

ANDA No. 079043

Prior to 12/8/2003

ANDA No. 076436

Prior to 12/8/2003

ANDA No. 076340

50 mg, 100 mg and 150 mg

Prior to 12/8/2003

ANDA No. 075442

For Oral Suspension 50 mg/5 mL and 200 mg/5 mL

DIFLUCAN FOR ORAL SUSPENSION

Prior to 12/8/2003

50 mg, 100 mg, 150 mg and 200 mg

Prior to 12/8/2003

Prior to 12/8/2003



http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076436s000LTR.pdf




DateApproval

Letter

Fluocinonide Ointment 0.05% LIDEX

Fluorouracil Cream 0.50% CARAC 7/29/2011

Fluoxetine Hydrochloride Tablets PROZAC 8/2/2001

Fluoxetine Hydrochloride Capsules PROZAC

8/2/2001

8/2/2001

8/2/2001

Fluoxetine Hydrochloride 90 mg PROZAC WEEKLY 3/24/2010

Fluoxetine Hydrochloride Oral Solution PROZAC 8/2/2001

Fluoxetine Hydrochloride Capsules SARAFEM 5/20/2008

Flutamide Capsules 125 mg EULEXIN

Prior to 12/8/2003

10 mg and 20 mg

Prior to 12/8/2003

ANDA No. 075755


Prior to 12/8/2003

ANDA No. 075049

ANDA No. 074803

ANDA No. 075465


Prior to 12/8/2003

ANDA No. 076237

20 mg (base)/5 mL

Prior to 12/8/2003

ANDA No. 075506

10 mg and 20 mg

Prior to 12/8/2003

ANDA No. 076287

Prior to 12/8/2003


http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75049_FLUOXETINE_Approv.pdf

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Approv.pdf





DateApproval

Letter

Fluticasone Furoate Nasal Spray 27.5 mcg Veramyst 7/15/2011

Fluticasone Propionate Lotion 0.05% CUTIVATE 7/28/2008 5/2/2011

Fluvastatin Capsules LESCOL 6/4/2008

Fluvastatin Sodium 80 mg LESCOL XL 3/15/2007

Fulvestrant Injection FASLODEX 10/1/2009

Fluvoxamine Maleate 100 mg LUVOX CR 4/20/2009

Fluvoxamine Maleate 150 mg LUVOX CR 4/13/2009

Formoterol Fumarate Inhalation Solution 0.02 mg/2 mL PERFOROMIST 1/21/2009

Fosamprenavir calcium Tablets 700 mg LEXIVA 1/18/2012

Injection 115 mg/vial EMEND 1/25/2012

Injection 150 mg/vial EMEND 1/25/2012

Fosinopril Sodium Tablets MONOPRIL 11/25/2003

Tablets MONOPRIL HCT 12/3/2004

Frovatriptan Succinate Tablets 2.5 mg FROVA 3/9/2011

ANDA No. 090759

20 mg and 40 mg


50 mg/mL, 2.5 mL and 5 mL syringe



Fosaprepitant dimeglumine

Fosaprepitant dimeglumine


Prior to 12/8/2003

ANDA No. 076139

Fosinopril Sodium and Hydrochlorothiazide

10 mg/12.5 mg and 20 mg/12.5 mg

Prior to 12/8/2003

ANDA No. 076608




DateApproval

Letter









Exclusivity Granted (Pre-MMA) (Second period granted)





FDA Citizen Petition Decision

Exclusivity Granted (Pre-MMA) (Expiration 9/15/2002; 134 mg & 200 mg) (Exclusivity on 67 mg likely expired before commercial marketing)

Exclusivity Forfeited (Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))

Exclusivity Granted (Pre-MMA; Shared) (Expiration 5/22/2006; 54 mg & 160 mg)

Exclusivity Granted (Pre-MMA; Shared) (Expiration 5/22/2006; 54 mg & 160 mg)


Exclusivity Forfeited (Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))



Exclusivity Expired (Pre-MMA)

No Exclusivity Granted (Likely Forfeiture)




Exclusivity Granted



Exclusivity Granted (Pre-MMA) (30 mg, 60 mg, and 180 mg)

Selectively Waived - See ANDA No. 76-447







Exclusivity Granted (Pre-MMA) (Expiration 10/21/2008; 30 mg & 60 mg) (Second Period)


Exclusivity Granted (Pre-MMA) (Second Period)









Exclusivity Granted (Pre-MMA) (Expiration 1/29/2002; 10 mg strength)



Exclusivity Expired (Pre-MMA) (Expiration 3/20/2010)

Court Decision Trigger - See ANDA No. 078572





Exclusivity Granted






Gabapentin Capsules NEURONTIN 9/12/2003

Gabapentin Oral Solution 250 mg/5 mL NEURONTIN 2/18/2011

Gabapentin Tablets GRALISE 10/31/2011

Gabapentin Tablets NEURONTIN 4/28/2004

Gabapentin Tablets NEURONTIN 10/21/2004

8 mg RAZADYNE ER 3/2/2006 9/15/2008

RAZADYNE ER 3/11/2006 9/15/2008

Tablets RAZADYNE 2/28/2005

9/11/2008

8/28/2008

Date of Submission

ANDA Approval Date

Approval Letter

100 mg, 300 mg and 400 mg

Prior to 12/8/2003

ANDA No. 075350

Prior to 12/8/2003

ANDA No. 078974

300 mg and 600 mg

100 mg, 300 mg and 400 mg

Prior to 12/8/2003

ANDA No. 076017

600 mg and 800 mg

Prior to 12/8/2003

ANDA No. 075694

Galantamine Hydrobromide


ANDA No. 078189



16 mg and 24 mg

ANDA No. 078189



ANDA No. 077593

ANDA No. 077603








DateApproval

Letter

Tablets RAZADYNE 2/28/2005 8/28/2008

2/6/2009

2/11/2009

Ganciclovir Sodium Capsules CYTOVENE 6/27/2003

Ganirelix Acetate Injection 3/30/2012

Gatifloxacin Injection TEQUIN 11/24/2004

Gatifloxacin 0.30% ZYMAR 7/19/2007 8/19/2011

Gatifloxacin 0.50% ZYMAXID 12/7/2010

Gatifloxacin Tablets TEQUIN

Injection TEQUIN 12/13/2004

Gemcitabine For Injection 200 mg/vial GEMZAR 11/1/2005 1/25/2011



ANDA No. 077605

ANDA No. 077604

ANDA No. 077608

250 mg and 500 mg

Prior to 12/8/2003

ANDA No. 076457

250 mcg/0.5 mL, 1 mL

PFS Ganirelix Acetate



Ophthalmic Solution

200 mg and 400 mg

Likely Prior to 12/8/2003

Gatifloxacin in Dextrose 5% in Plastic Container

2 mg/mL, 100 mL and 200 mL containers (plastic)

ANDA No. 077983





DateApproval

Letter

Gemcitabine For Injection 1g/vial GEMZAR 11/14/2005

Gemcitabine For Injection 2 g/vial GEMZAR 8/24/2007 11/15/2010

Gemifloxacin Mesylate Tablets 320 mg FACTIVE 3/4/2008

Glatiramer Acetate Injection COPAXONE 12/27/2007

Tablets AVANDARYL 12/22/2006

Tablets AVANDARYL 5/30/2008

Glipizide GLUCOTROL XL

9/8/2003

9/8/2003

Glyburide Tablets GLYNASE 12/22/1997

Tablets GLUCOVANCE 2/18/2004

1/25/2011(Initial approval on 12/18/2008, but converted to tentative approval)ANDA No. 077983

ANDA No. 079183


Glimepiride and Rosiglitazone Maleate

1 mg/4 mg, 2 mg/4 mg and 4 mg/4 mg

Glimepiride and Rosiglitazone Maleate




Prior to 12/8/2003

ANDA No. 076467 (10

mg)

ANDA No. 076467

1.5 mg, 3 mg, 4.5 mg and 6 mg

Prior to 12/8/2003

ANDA No. 074591

Glyburide/Metformin Hydrochloride

1.25mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg

Prior to 12/8/2003

ANDA No. 076345






DateApproval

Letter

Glycopyrrolate Tablets 1 mg ROBINUL 8/14/2009

Glycopyrrolate Tablets 1.5 mg ROBINUL FORTE 5/6/2009

Glycopyrrolate Tablets 2 mg ROBINUL FORTE 10/12/2010

Glycopyrrolate Oral Solution 1 mg/5 mL CUVPOSA 6/20/2012

Injection KYTRIL 3/8/2007

Injection KYTRIL 6/1/2004

12/31/2007

1/3/2008

Injection KYTRIL 7/19/2004 12/31/2007

Guaifenesin MUCINEX 6/9/2006

MUCINEX DM 12/17/2008

MUCINEX-D 12/29/2008

Granisetron Hydrochloride

0.1 mg/mL, 1 mL single dose vial


1 mg/mL, 1 mL vials

ANDA No. 077165

ANDA No. 077963


1 mg/mL, 4 mL multi-dose vials

ANDA No. 077177


600 mg and 1.2 gm

Guaifenesin and Dextromethorphan


600 mg/30 mg and 1200 mg/60 mg

Guaifenesin and Pseudoephedrine Hydrochloride


600 mg/60 mg and 1200 mg/120 mg



DateApproval

Letter

INTUNIV 12/29/2009 10/5/2012Guanfacine Hydrochloride



ANDA No. 200881


Exclusivity Granted











Exclusivity Granted (Expiration 5/14/2011) (Suitability Petition - Docket No. 2006P-0145)

Exclusivity Presumably Selectively Waived, Relinquished, or Triggered by Authorized Generic Marketing (Pre-MMA) (2.5 mg & 10 mg)





(Suitability Petition ANDA - Docket No. 2006P-0300)

No Exclusivity Granted (Presumably Forefeited)

Exclusivity Granted (Expiration 6/28/2008; Presumably shared) FDA Letter Decision

Exclusivity Granted (Expiration 6/28/2008; Presumably shared)



http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM151237.pdf



Tablets MAXZIDE 12/8/1987

Tablets VICOPROFEN 2/24/2006 10/19/2007

Tablets 5 mg/200 mg VICOPROFEN 5/27/2005


Tablets VICOPROFEN

4/11/2003

12/31/2003


Hydrocortisone Butyrate Cream 0.10% 6/28/2010

EXALGO 9/2/2010

16 mg EXALGO 8/2/2010

Oral Solution 5 mg/5mL DILAUDID 2/25/2011

Date of Submission

ANDA Approval Date

Approval Letter

Hydrochlorthiazide and Triamterene

50 mg and 75 mg

Prior to 12/8/2003

ANDA No. 071360

Hydrocodone Bitartrate and Ibuprofen

2.5 mg/200 mg ANDA No. 076642



Prior to 12/8/2003

ANDA No. 076642


7.5 mg/200 mg Prior to

12/8/2003

ANDA No. 076023

ANDA No. 076604


Likely On or After

12/8/2003

ANDA No. 077723

LOCOID LIPOCREAM

Hydromorphone Hydrochloride


8 mg and 12 mg



Hydromorphone hydrochloride

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076642%20s005ltr.pdf



DateApproval

Letter

Injection 10 mg/mL DILAUDID-HP 11/4/2011

Injection 2 mg/mL DILAUDID 6/22/2011

Hydromorphone hydrochloride




(Suitability Petition - Docket No. 2002P-0270)




Exclusivity Granted (Pre-MMA) (Expiration 12/5/2004) (Suitability Petition - Docket No. 2002P-0270)

Exclusivity Granted (Pre-MMA) (Expiration10/11/2004) (second period)




Ibandronate Sodium Injection BONIVA 8/31/2007

Ibandronate Sodium Tablets BONIVA 5/16/2007

3/19/2012

3/19/2012

3/19/2012

Ibuprofen Oral Drops 40 mg/mL

Ibuprofen Oral Suspension 6/29/2007

Ibuprofen Oral Suspension 100 mg/5 mL (RX) MOTRIN

Ibuprofen Oral Suspension 100 mg/5 mL

Ibuprofen Chewable Tablets 1/16/2004

Ibuprofen Lysine Injection NEOPROFEN 10/1/2010

Tablets DUEXIS 12/6/2011

Date of Submission

ANDA Approval Date

Approval Letter

1 mg/mL, 3 mL Vial

2.5 mg and 150 mg

ANDA No. 078948

ANDA No. 078995

ANDA No. 078998

CHILDREN'S MOTRIN DROPS

Prior to 12/8/2003

50 mg/1.25 mL CONCENTRATED MOTRIN INFANT

DROPS

Prior to 12/8/2003

(OTC) CHILDREN'S MOTRIN

Prior to 12/8/2003

50 mg and 100 mg

CHILDREN'S MOTRIN, JUNIOR

STRENGTH MOTRIN

Prior to 12/8/2003

ANDA No. 076359

10 mg/mL, 2 mL vial

Ibuprofen and Famotidine

800 mg/26.6 mg






DateApproval

Letter

Oral Suspension 11/5/2003

Tablets 200 mg/30 mg 4/17/2001

Capsules 200 mg/30 mg 12/27/2004

Ifosfamide For Injection IFEX 5/28/2002

Ifosfamide Injection IFEX

Ifosfamide/ Mesna IFEX/MESNEX KIT 2/26/2002

Ifosfamide/ Mesna IFEX/ MESNEX KIT

Imatinib Mesylate Tablets GLEEVEC 3/12/2007

Imiquimod Cream 5% ALDARA 10/17/2006 2/25/2010

Ibuprofen and Pseudoephedrine Hydrochloride

100 mg/ 15 mg per 5 mL

CHILDREN'S MOTRIN COLD

Prior to 12/8/2003

ANDA No. 076478

Ibuprofen and Pseudoephedrine Hydrochloride

ADVIL COLD AND SINUS

Prior to 12/8/2003

ANDA No. 074567

Ibuprofen Potassium and Pseudoephedrine Hydrochloride

ADVIL COLD AND SINUS

1 g/vial and 3 g/vial

Prior to 12/8/2003

ANDA No. 076078

50 mg/mL, 20 mL vials and 60 mL vials

Prior to 12/8/2003

For Injection/ Injection Kit

1 g/vial; 100 mg/mL, 10 mL vials and 3 g/vial; 100 mg/mL, 10 mL vials

Prior to 12/8/2003

ANDA No. 075874

Injection/ Injection Kit

50 mg/mL, 20 mL and 60 mL vials; 100 mg/mL, 10 mL vial

Prior to 12/8/2003

100 mg and 400 mg

ANDA No. 078548






DateApproval

Letter

Indomethacin 75 mg INDOCIN SR

Irbesartan Tablets AVAPRO 5/25/2004 3/30/2012

Tablets AVALIDE 11/10/2004 3/30/2012

Tablets AVALIDE 6/6/2006 3/30/2012

Irinotecan Hydrochloride Injection CAMPTOSAR 7/26/2004 2/20/2008

Itraconazole Capsules 100 mg SPORANOX 5/28/2004

Ixabepilon Injection IXEMPRA KIT 4/16/2012


Prior to 12/8/2003

75 mg, 150 mg and 300 mg

ANDA No. 077159

Irbesartan and Hydrochlorothiazide

150 mg/12.5 mg and 300 mg/12.5 mg

ANDA No. 077369

Irbesartan and Hydrochlorothiazide

300 mg/25 mg ANDA No. 077369


ANDA No. 077219

Prior to 12/8/2003

ANDA No. 076104

15 mg/vial and 45 mg/vial, single-use vials









No Exclusivity Granted (Pre-MMA; Rx-to-OTC Switch)


Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV)) (150 mg)

Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV)) (150 mg)


See ANDA No. 074937








Exclusivity Granted (Expiration 8/24/2010) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV))


Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV)) (Expiration 9/26/2012)

FDA Petition Decision









DateApproval

Letter



Ketoconazole Foam 2% EXTINA 7/30/2009 8/25/2011

Ketoprofen Capsules ORUDIS

Ketorolac Tromethamine Injection TORADOL

Ketorolac Tromethamine Opthalmic Solution 0.45% ACUVAIL 8/24/2011

0.50% ACULAR

0.40% ACULAR LS 1/28/2005

Ketorolac Tromethamine Tablets 10 mg TORADOL

Ketorolac Tromethamine Nasal Spray SPRIX 3/12/2012

Ketotifen Fumarate 0.025% ZADITOR 12/23/2004 5/9/2006

Date of Submission

ANDA Approval Date

Approval Letter

ANDA No. 091550


Prior to 12/8/2003

15 mg/mL and 30 mg/mL

Prior to 12/8/2003

Ketorolac Tromethamine Ophthalmic Solution Prior to

12/8/2003

Ketorolac Tromethamine Ophthalmic Solution

Prior to 12/8/2003

15.75 mg/spray

Ophthalmic Solution ANDA No.

077354





No Exclusivity Granted (Forfeiture)






Lactulose Oral Syrup 10 g/15 mL CEPHULAC

Lactulose Oral Syrup 10 g/15 mL CHRONULAC

Lamivudine Tablets 100 mg EPIVIR-HBV 10/31/2007

Lamivudine Tablets EPIVIR 10/16/2007

Tablets COMBIVIR 6/26/2007 5/25/2011

Lamivudine Oral Solution 10 mg/mL EPIVIR 11/22/2011

Lamotrigine Tablets LAMICTAL 8/30/2006

Lamotrigine Chewable Tablets LAMICTAL CD 6/21/2006

Lamotrigine LAMICTAL ODT 12/21/2009

Lansoprazole PREVACID 12/5/2005

Date of Submission

ANDA Approval Date

Approval Letter

Prior to 12/8/2003

Prior to 12/8/2003

150 mg and 300 mg

Lamivudine and Zidovudine

150 mg/300 mg

ANDA No. 079081

25 mg, 100 mg, 150 mg and 200 mg

Prior to 12/8/2003

ANDA No. 076388


Prior to 12/8/2003

ANDA No. 076420


25 mg, 50 mg, 100 mg, and 200 mg

Delayed-release Pellets/Capsules

15 mg and 30 mg





DateApproval

Letter

Lansoprazole PREVACID 12/27/2006 10/15/2010

Lanthanum Carbonate Chewable Tablet FOSRENOL 10/27/2008

Lapatinib Ditosylate Tablets 250 mg TYKERB 3/14/2011

Latanoprost 0.005% XALATAN

Lenalidomide Capsules REVLIMID 8/30/2010

Lenalidomide Capsules 25 mg REVLIMID 7/12/2010

Letrozole Tablets 2.5 mg FEMARA 3/2/2006 12/24/2008

Leuprolide Acetate Injection (depot) 7.5 mg/vial LUPRON DEPOT

Inhalation Solution XOPENEX 6/20/2005 4/9/2008

Inhalation Solution 0.25% XOPENEX 5/23/2006 3/20/2009

Levalbuterol Tartrate Inhalation Aerosol XOPENEX 2/27/2012

Levetiracetam Tablets KEPPRA

Levetiracetam Tablets 1000 mg KEPPRA 1/24/2007

Delayed-release Orally Disintegrating Tablets

15 mg and 30 mg

ANDA No. 078730

500 mg, 750 mg and 1000 mg


12/8/2003


ANDA No. 078190

Prior to 12/8/2003

Levalbuterol Hydrochloride

0.0103%, 0.021% and 0.042%

ANDA No. 077756

Levalbuterol Hydrochloride

ANDA No. 078309

0.045 mg/actuation

250 mg, 500 mg and 750 mg

Prior to 12/8/2003

http://www.tevausa.com/assets/base/products/fda/Lans_78-730.pdf



DateApproval

Letter

Levetiracetam KEPPRA XR 1/7/2011

9/12/2011

9/12/2011

9/12/2011

9/12/2011

9/12/2011

9/12/2011

9/12/2011

10/4/2011

12/19/2011

Oral Solution 0.5 mg/mL XYZAL 1/14/2009 11/7/2011

Tablets 5 mg XYZAL 12/17/2007 11/26/2010


500 mg and 750 mg

ANDA No. 091093

ANDA No. 091261

ANDA No. 091285

ANDA No. 091291

ANDA No. 091430

ANDA No. 091399

ANDA No. 091557

ANDA No. 091360

ANDA No. 200475

Levocetirizine Dihydrochloride

ANDA No. 091263

Levocetirizine Dihydrochloride

ANDA No. 090229







DateApproval

Letter

Levofloxacin Injection

Levofloxacin Injection 25 mg/mL LEVAQUIN

Levofloxacin 0.50% QUIXIN

Levofloxacin Oral Solution 25 mg/mL LEVAQUIN 7/30/2009

Levofloxacin Tablets LEVAQUIN

Levoleucovorin Calcium Injection FUSILEV 10/26/2011

Tablets LYBREL 10/5/2007

Tablets SEASONALE 3/29/2004 9/6/2006

Tablets LOSEASONIQUE 11/16/2009

10/25/2011

10/26/2011

5 mg/mL; 50 mL, 100 mL and 150 mL vials

LEVAQUIN IN DEXTROSE 5% IN

PLASTIC CONTAINER

Prior to 12/8/2003

Prior to 12/8/2003


12/8/2003

250 mg, 500 mg and 750 mg

Prior to 12/8/2003

10/15/2004 (Converted to a

Tentative Approval

2/1/2005)

ANDA No. 076276


Tentative Approval

7/12/2006)

ANDA No. 076361

10 mg/mL, 17.5 mL vial and 25 mL vial

Levonorgestrel and Ethinyl Estradiol

0.09 mg/0.02 mg

Levonorgestrel and Ethinyl Estradiol

0.15 mg/0.03 mg

ANDA No. 077101

Levonorgestrel; Ethinyl Estradiol; Ethinyl Estradiol

0.1 mg/0.02 mg and 0.01 mg

ANDA No. 200407

ANDA No. 091674





DateApproval

Letter

Tablets SEASONIQUE 1/22/2008 5/31/2011

Levothyroxine Sodium Tablets LEVOXYL

Lidocaine Topical Patch 5% LIDODERM 11/13/2009 8/23/2012

Linezolid Injection ZYVOX 12/29/2009

Linezolid Injection ZYVOX 9/1/2009 6/27/2012

Linezolid Oral Suspension 100 mg/5 mL ZYVOX 8/3/2009

Linezolid Tablets 600 mg ZYVOX 12/21/2005

Capsules VYVANSE 2/23/2011

Chewable Tablets 2 mg/125 mg 8/30/2002

Levonorgestrel; Ethinyl Estradiol; Ethinyl Estradiol

0.15 mg/0.03 mg/0.01 mg

ANDA No. 078834

0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.150 mg, 0.175 mg, 0.2 mg and 0.3 mg

Prior to 12/8/2003

ANDA No. 200675

2 mg/mL, 100 mL bag

2 mg/mL, 300 mL bag

ANDA No. 200222

Lisdexamfetamine Dimesylate


Loperamide Hydrochloride and Simethicone

IMODIUM ADVANCED

Prior to 12/8/2003

ANDA No. 076029






DateApproval

Letter

Tablets 12/29/2004 9/6/2006

Lopinavir and Ritonavir Tablets KALETRA 12/23/2008

Loratadine Syrup 1 mg/mL CLARITIN 11/7/2003

Loratadine Tablets 10 mg CLARITIN 1/21/2003

Loratadine 10 mg CLARITIN REDITABS 2/10/2003

5 mg/120 mg 1/30/2003

10 mg/240 mg 2/21/2003

Losartan Potassium Tablets COZAAR 4/6/2010

Tablets HYZAAR 5/24/2004 4/6/2010

Tablets HYZAAR 4/4/2006

Loperamide Hydrochloride and Simethicone

2 mg/125 mg (OTC)

IMODIUM ADVANCED

ANDA No. 077500

100 mg/25 mg and 200 mg/50 mg

Prior to 12/8/2003

ANDA No. 075505

Prior to 12/8/2003

ANDA No. 075209


Prior to 12/8/2003

ANDA No. 075822

Loratadine/ Pseudoephedrine


CLARITIN D-12 HOUR

Prior to 12/8/2003

ANDA No. 076050

Loratadine/ Pseudoephedrine


CLARITIN D-24 HOUR

Prior to 12/8/2003

ANDA No. 075706

25 mg, 50 mg, and 100 mg


ANDA N0. 076958

Losartan Potassium and Hydrochlorothiazide

50 mg/12.5 mg and 100 mg/25 mg

ANDA No. 077157

Losartan Potassium and Hydrochlorothiazide

100 mg/12.5 mg

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077500s000_ltr.pdf

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75505apltr.pdf

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75209altr.pdf

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75822Altr.pdf


http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75706_Loratadine%20And%20Pseudoephedrine%20Sulfate_Approv.pdf





DateApproval

Letter

Lovastatin and Niacin 20 mg/500 mg ADVICOR 9/22/2008

Lovastatin and Niacin 20 mg/750 mg ADVICOR 12/17/2008

Lovastatin and Niacin ADVICOR 5/22/2008

Lovastatin and Niacin ADVICOR 11/19/2009

Lubiprostone Capsules AMITIZA 8/20/2012




20 mg/1000 mg


40 mg/1000 mg

8 mcg and 24 mcg







Exclusivity Granted (Pre-MMA) (Expiration 2/25/2007; 5 mg) (Expiration 2/25/2006; 25 mg)

No Exclusivity Granted (Forfeiture; Presumably Patent Expiration)


Exclusivity Granted

Exclusivity Granted


No Exclusivity Granted (Pre-MMA) (patent exp)


No Exclusivity Granted (Pre-MMA) (patent exp)

Exclusivity Forfeited - Patent Expiration (FDC Act § 505(j)(5)(D)(i)(VI))


Exclusivity Granted















Exclusivity Granted

Exclusivity Granted

Exclusivity Granted

No Exclusivity Granted (Pre-MMA) (patent expiration)

Exclusivity Granted (Pre-MMA) (250 mg & 500 mg)












FDA Letter Decision


FDA Letter Decision





Malathion Topical Lotion 0.50% OVIDE 3/16/2011

Maraviroc Tablets SELZENTRY 8/8/2011

Tablets 250 mg LARIAM 2/20/2002

Megestrol Acetate Oral Suspension 40 mg/mL MEGACE 7/25/2001

Megestrol Acetate Oral Suspension 125 mg/mL MEGACE ES 4/27/2011

Meloxicam Oral Suspension 7.5 mg/5 mL MOBIC 12/17/2009

Tablets NAMENDA 10/16/2007

4/14/2010

5/5/2010

Mesalamine 400 mg ASACOL 6/22/2007

Mesalamine 800 mg ASACOL HD 7/13/2011

Mesalamine 1.2 g LIALDA 12/16/2009

Date of Submission

ANDA Approval Date

Approval Letter

150 mg and 300 mg

Mefloquine Hydrochloride Prior to

12/8/2003ANDA No. 076175

Prior to 12/8/2003

ANDA No. 075671

Memantine Hydrochloride

5 mg and 10 mg

ANDA No. 090048

ANDA No. 090058




http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76175.ap.pdf

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-671_Megestrol%20Acetate.pdf




DateApproval

Letter

Mesalamine 0.375 g APRISO 4/3/2012

Metaxalone Tablets 400 mg SKELAXIN

Metaxalone Tablets 800 mg SKELAXIN 11/4/2004 3/31/2010

500 mg GLUCOPHAGE XR

6/16/2004

10/28/2003

7/30/2004

10/1/2004

750 mg GLUCOPHAGE XR 10/14/2004

FORTAMET 10/14/2008 6/29/2011

GLUMETZA 7/27/2009

10 mg RITALIN LA 5/21/2007

METADATE CD 5/13/2005 7/19/2012


Prior to 12/8/2003

ANDA No. 040445

Metformin Hydrochloride Extended-release Tablets

Prior to 12/8/2003

ANDA No. 076172

ANDA No. 76545

ANDA No. 076249

ANDA No. 076450


Prior to 12/8/2003

ANDA No. 76863


500 mg and 1000 mg

ANDA No. 090692


500 mg and 1000 mg

Methylphenidate Hydrochloride





ANDA No. 77707







DateApproval

Letter

RITALIN LA 8/21/2006 12/1/2011

40 mg METADATE CD 3/15/2007 7/19/2012

CONCERTA 7/19/2005 12/28/2012

Oral Solution METHYLIN 4/13/2010 7/23/2010

Methylphenidate DAYTRANA 4/13/2011

Injection REGLAN

METOZOLV ODT 8/24/2010

Metoprolol Succinate TOPROL XL

5/18/2007

7/31/2006




ANDA No. 078458



ANDA No. 078873



18 mg, 27 mg, 36 mg and 54 mg

ANDA No. 202608


5 mg/5 mL and10 mg/5 mL

ANDA No. 091601

Transdermal System

10 mg/9 hrs, 15 mg/9 hrs, 20 mg/9 hrs and 30 mg/9 hrs

Metoclopramide Hydrochloride

5 mg/mL, 2 mL, 10 mL, 20 mL and 30 mL vials

Prior to 12/8/2003

Metoclopramide Hydrochloride


5 mg and 10 mg


25 mg, 50 mg, 100 mg and

200 mg

Prior to 12/8/2003

ANDA No. 076640


ANDA No. 076969

Prior to 12/8/2003








DateApproval

Letter

Metronidazole Vaginal Gel 0.75% 9/2/2004 10/31/2006

Metronidazole Topical Gel 1% METROGEL 10/21/2008 7/22/2011

Miconazole Nitrate 2% and 1.2 g 12/5/2007 6/2/2010

SOLODYN

2/3/2009

3/17/2009

8/13/2009

7/20/2010

SOLODYN 12/2/2010

SOLODYN 11/19/2009

105 mg SOLODYN 12/28/2010

Minoxidil 5% MEN’S ROGAINE 4/6/2009 4/28/2011

METROGEL-VAGINAL

ANDA No. 077264

ANDA No. 090903

Vaginal Cream and Suppository

MONISTAT 1 COMBINATION PACK

ANDA No. 079114

Minocycline Hydrochloride


45 mg, 90 mg and 135 mg


2/5/2009

ANDA No. 090024

ANDA No. 065485

ANDA No. 090422

ANDA No. 090911



55 mg and 80 mg



65 mg and 115 mg



Topical Aerosol Foam

ANDA No. 091344



http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/090911s000lbl.pdf




DateApproval

Letter

Mirtazapine Tablets REMERON

1/24/2003

4/22/2004

Mirtazapine REMERON SOLTAB

12/17/2003

8/31/2005

6/28/2005

Modafinil Tablets PROVIGIL

Moexipril Hydrochloride Tablets UNIVASC 5/8/2003

Tablets UNIRETIC 1/15/2004

Mometasone Furoate Nasal Spray 50 mcg/ Spray NASONEX 8/7/2009

Mometasone Furoate 0.10% ELOCON

7.5 mg, 15 mg, 30 mg, and 45 mg

Prior to 12/8/2003

ANDA No. 076119

ANDA No. 076541



Prior to 12/8/2003

ANDA No. 076307

ANDA No. 076689

ANDA No. 076901

100 mg and 200 mg

Prior to 12/8/2003

ANDA No. 076596

7.5 mg and 15 mg

Priot to 12/8/2003

ANDA No. 076204

Moexipril Hydrochloride and Hydrochlorothiazide

7.5mg/12.5mg 15 mg/25 mg and 15 mg/12.5 mg

Topical Solution (Cream)

Prior to 12/8/2003





DateApproval

Letter

Mometasone Furoate 0.10% ELOCON 6/10/2004 4/6/2005

Montelukast Tablets 10 mg SINGULAIR 2/20/2007

Montelukast Sodium Chewable Tablets SINGULAIR 12/26/2006

Montelukast Sodium Oral Granules 4 mg 10/17/2008 8/3/2012

Morphine Sulfate AVINZA 6/4/2007

Morphine Sulfate AVINZA 7/30/2009

EMBEDA 5/28/2010

60 mg/2.4 mg EMBEDA 5/25/2010

100 mg/4 mg EMBEDA 5/3/2010

0.50% VIGAMOX 12/22/2005

10.50% MOXEZA 2/29/2012

Tablets 400 mg AVELOX

Mycophenolic Acid 180 mg MYFORTIC 6/4/2009

Topical Solution (Lotion)

ANDA No. 077180

4 mg and 5 mg

SINGULAR GRANULES

ANDA No. 090955


30 mg, 60 mg, 90 mg and 120 mg


45 mg and 75 mg

Morphine Sulfate and Naltrexone Hydrochloride


30 mg/1.2 mg, 50 mg/2 mg and 80 mg/3.2 mg





Moxifloxacin Hydrochloride

Ophthalmic Solution/Drops


Ophthalmic Solution


Likely Prior to 12/8/2003





DateApproval

Letter

Mycophenolic Acid 360 mg MYFORTIC 2/2/2009

Mycophenolic Mofetil Tablets 500 mg CELLCEPT 4/22/2009

Mycophenolic Mofetil Capsules 250 mg CELLCEPT 4/22/2009

Mycophenolic Mofetil 200 mg/mL CELLCEPT 3/25/2011



ANDA No. 090499


ANDA No. 090419

For Oral Suspension



Exclusivity Granted (Shared)





Exclusivity Granted (Pre-MMA;Shared)


Exclusivity Granted (Failure to Obtain Tentative Approval in 30 Months - FDC Act § 505(j)(5)(D)(i)(IV)), but Citizen Petition Extension Applied - FDC Act § 505(q)(1)(G))


Exclusivity Granted (Pre-MMA;Shared) (Expiration 5/29/2004)

Exclusivity Granted (Pre-MMA; Shared)

Selective Waiver of Exclusivity - See ANDA No. 076269






Exclusivity Granted



Exclusivity Granted/Forfeited (180-Day Punt; Pre-MMA/MMA-Straddle; Failure to Obtain Tentative Approval in 30 Months - FDC Act § 505(j)(5)(D)(i)(IV))

Exclusivity Granted (Pre-MMA) (Expiration 1/22/2008; 100 mg & 200 mg)

Exclusivity Granted/Forfeited (180-Day Punt) (25 mg; Failure to Obtain Tentative Approval in 30 Months - FDC Act § 505(j)(5)(D)(i)(IV))


50 mg; See ANDA No. 076969

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076969s002,%20s003ltr.pdf


Exclusivity Granted

Exclusivity Granted

Exclusivity Granted (QI Act Shared)




Tentative Approval(s) Granted (80 mg)



Exclusivity Granted

Exclusivity Granted/Forfeited (180-Day Punt) (Expiration 12/24/2010) (Failure-to-Market Delisting - FDC Act § 505(j)(5)(D)(i)(I))




Exclusivity Granted (Pre-MMA) (Expiration 7/16/2003; 15 mg & 30 mg strengths) (Exclusivity Granted for 45 mg, but expired)

See ANDA No. 076122

Exclusivity Granted (Pre-MMA) (7.5 mg; Suitability Petition - Docket No. 2002P-0249)

Exclusivity Granted (Pre-MMA) (Expiration 6/14/2004; 15 mg & 30 mg strengths)

Exclusivity Granted (Pre-MMA; Shared) (Expiration 2/28/2006; 45 mg strength)

Exclusivity Granted (Pre-MMA; Shared) (Expiration 2/28/2006; 45 mg strength)

Exclusivity Granted (Pre-MMA) (Expiration 9/26/2012) (Exclusivity Triggered By Authorized Generic Marketing)

FDA Letter Decision


See ANDA No. 076679


http://www.hpm.com/pdf/blog/PROVIGIL%20-%20FDA%20Letter%20Decision.pdf






Exclusivity Forfeited (Multiple ANDAs Approved Upon Patent/PED Expiration)

Exclusivity Forfeited (Multiple ANDAs Approved Upon Patent/PED Expiration)

Exclusivity Forfeited (Amended Patent Certification - FDC Act § 505(j)(5)(D)(i)(III))



Exclusivity Granted

Exclusivity Granted



Nabumetone Tablets RELAFEN

5/26/2000

6/6/2000

9/24/2001

Naproxen Sodium NAPRELAN

VIMOVO 11/5/2010

Tablets 500 mg/85 mg TREXIMET 7/23/2008

Nateglinide Tablets STARLIX 12/22/2004

9/9/2009

9/9/2009

9/9/2009

Date of Submission

ANDA Approval Date

Approval Letter

500 mg and 750 mg

Prior to 12/8/2003

ANDA No. 075189

ANDA No. 075179

ANDA No. 075189


375 mg (base) and 500 mg (base)

Prior to 12/8/2003

Naproxen and Esomeprazole Magnesium

Delayed-release Tablet

375 mg/20 mg and 500 mg/20 mg

Naproxen Sodium and Sumatriptan Succinate

60 mg and 120 mg

ANDA No. 077463

ANDA No. 077467

ANDA No. 077461

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75189AP-TA.PDF

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75179TAAP.PDF

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75189S01ltr.pdf






DateApproval

Letter

Nateglinide Tablets STARLIX 12/22/2004

9/9/2009

Nebivolol Hydrochloride Tablets BYSTOLIC 12/19/2011

Tablets SERZONE

Niacin NIASPAN

4/14/2005

4/26/2005

Niacin and Simvastatin SIMCOR 2/12/2010

Niacin and Simvastatin 750 mg/20 mg SIMCOR 2/17/2010



Niacin and Simvastatin 500 mg/40 mg SIMCOR 2/9/2011

Injection CARDENE 12/27/2006

Nicotine HABITROL

60 mg and 120 mg

ANDA No. 077461

2.5 mg, 5 mg, 10 mg, and 20 mg

Nefazodone Hydrochloride

50 mg, 100 mg, 150 mg 200 mg and 250 mg

Prior to 12/8/2003


500 mg, 750 mg and 1000 mg

Prior to 12/8/2003

ANDA No. 076250

ANDA No. 076378


500 mg/20 mg



1000 mg/20 mg


1000 mg/40 mg


Nicardipine Hydrochloride

2.5 mg/mL, 10 mL Ampoules

Transdermal System

7 mg/day, 14 mg/day and 21 mg/day

Prior to 12/8/2003






DateApproval

Letter

Nicotine Polacrilex Troche/Lozenge COMMIT 1/31/2006

Nifedipine Capsules PROCARDIA 7/10/1989

Nifedipine ADALAT CC

3/10/2000

12/4/2000

8/16/2002

Nifedipine PROCARDIA XL

12/17/1999

9/27/2000

3/23/2004

Nisoldipine SULAR 3/2/2009 1/26/2011

Nisoldipine SULAR 11/7/2007

2 mg and 4 mg Post

12/8/2003ANDA No.

077007

10 mg and 20 mg

Prior to 12/8/2003

ANDA No. 072409



Prior to 12/8/2003

ANDA No. 075128

ANDA No. 075269

ANDA No. 076070



Prior to 12/8/2003

ANDA No. 075108

ANDA No. 075289

ANDA No. 075414


8.5 mg and 17 mg

ANDA No. 091001


20 mg and 30 mg









DateApproval

Letter

Nisoldipine SULAR 11/28/2008 1/26/2011

Nisoldipine 40 mg SULAR 6/11/2007

Capsules 75 mg/25 mg MACROBID 3/22/2004

Nitroglycerin Sublingual Tablets NITROSTAT 10/19/2005

Nitroglycerin 0.1 mg/hr TRANSDERM-NITRO

Nitroglycerin NITRO-DUR

Nitroglycerin Sublingual Spray 4/17/2012

Nizatidine Capsules AXID

Nizatidine Oral Solution 15 mg/mL AXID 5/14/2008 11/18/2009

ORTHO EVRA 3/22/2007


25.5 mg and 34 mg

ANDA No. 091001


Nitrofurantoin Monohydrate/ Macrocrystals

Prior to 12/8/2003

ANDA No. 076648

0.3 mg, 0.4 mg and 0.6 mg

Transdermal System

Prior to 12/8/2003

Transdermal System

0.1 mg/hr, 0.2 mg/hr, 0.3 mg/hr, 0.4 mg/hr, 0.6 mg/hr and 0.8 mg/hr

Prior to 12/8/2003

400 mcg/spray, 4.9 g and 12 g bottles

NITROLINGUAL PUMPSPRAY

150 mg and 300 mg

Prior to 12/8/2003

ANDA No. 090576

Norelgestromin and Ethinyl Estradiol

Transdermal System

0.15 mg/0.02 mg per 24 hours






DateApproval

Letter

Tablets FEMHRT 11/6/2009

Tablets ESTROSTEP FE 10/26/2007

Tablets ESTROSTEP 21 10/26/2007

Tablets LOESTRIN 24 FE 4/17/2006 9/1/2009

Tablets LO LOESTRIN FE 4/29/2011

Chewable Tablets 4/27/2007 8/5/2010

Chewable Tablets GENERESS FE 8/5/2011

Tablets 8/30/2002

Norethindrone Acetate/ Ethinyl Estradiol

1 mg/0.005 mg

Prior to 12/8/2003

ANDA No. 076221


1 mg/ 0.02 mg, 1 mg/0.03 mg and 1 mg /0.035 mg

Prior to 12/8/2003

ANDA No. 076105


1 mg/0.02 mg, 1 mg/ 0.03 mg and 1 mg /0.035 mg

Prior to 12/8/2003

ANDA No. 076405

Norethindrone Acetate/ Ethinyl Estradiol and Ferrous Fumarate

1 mg/0.02 mg and 75 mg

ANDA No. 078267

Norethindrone Acetate and Ethinyl Estradiol / Ethinyl Estradiol and Ferrous Fumarate

1 mg/0.01 mg, 0.01 mg and 75 mg

Norethindrone and Ethinyl Estradiol and Ferrous Fumarate

0.4 mg/0.035 mg

OVCON-35 FE FEMCON FE NDA 21-

490 ANDA No. 078965

Norethindrone and Ethinyl Estradiol and Ferrous Fumarate

0.8 mg/0.025 mg and 75 mg

Norethindrone/ Ethinyl Estradiol

0.5 mg/ 0.035 mg, 0.75 mg/ 0.035 mg and 1 mg /0.035 mg

ORTHO-NOVUM 7/7/7, 21 AND 28 DAY

Prior to 12/8/2003

ANDA No. 075478





DateApproval

Letter

Tablets 6/29/2009

Tablets

Capsules PAMELOR

Norgestimate/ Ethinyl Estradiol

0.18 mg /0.025 mg, 0.215 mg /0.025 mg and 0.25 mg /0.025 mg

ORTHO TRI-CYCLEN LO, 28 DAY

Prior to 12/8/2003

ANDA No. 076784

Norgestimate/ Ethinyl Estradiol

0.18 mg /0.035 mg, 0.215 mg /0.035 mg and 0.25 mg /0.035 mg

ORTHO TRI-CYCLEN, 21 AND 28

DAY

Prior to 12/8/2003

12/18/2002 (Rescinded;

Consent Judgment &

Order); 12/29/2003

(Reapproved)

ANDA No. 075808

Nortriptyline Hydrochloride

10 mg, 25 mg, 50 mg and 75 mg

Prior to 12/8/2003






Exclusivity Granted (Pre-MMA) (Expired 2/16/2002; 500 mg strength)

Exclusivity Granted (Pre-MMA) (Expired 2/23/2002; 750 mg strength)

Exclusivity Granted (Pre-MMA) (Expired 2/23/2002; 750 mg strength) (Remainder of 180-day exclusivity "selectively transferred" from ANDA No. 75-179)





FDA Letter Decision


Exclusivity Granted (Pre-MMA) (500 mg & 750 mg)



Exclusivity Granted



Exclusivity Presumably Granted (Pre-MMA) (30 mg)

FTC Consent Order


FTC Consent Order


No Exclusivity Granted (Pre-MMA) (30 mg) FDA Petition Response Docket No. 2000P-1446


Exclusivity Granted & Relinquished (Pre-MMA) (90 mg)

No Exclusivity Granted (Forfeited)

http://www.ftc.gov/opa/2002/06/biovailelan.shtm

http://www.ftc.gov/opa/2002/06/biovailelan.shtm

http://www.fda.gov/ohrms/dockets/dailys/01/Mar01/030501/pav0001.pdf


Exclusivity Granted


Exclusivity Granted

Exclusivity Presumably Forfeited - Patent Expiration (FDC Act § 505(j)(5)(D)(i)(VI))




Exclusivity Presumably Granted (Pre-MMA)

No Exclusivity Granted (Pre-MMA) (Applicant did not maintain a consistent PIV certification)








No Exclusivity Granted (Pre-MMA) - (28-day) (Patent Expiration & Conversion to Paragraph III)



Octreotide Acetate Injection 3/28/2005

Octreotide Acetate Injection SANDOSTATIN 4/8/2005

Octreotide Acetate Injection 1/17/2008

Ofloxacin Otic Solution 0.30% FLOXIN 9/28/2007

Olanzapine Tablets ZYPREXA 10/24/2011

Olanzapine Tablets 20 mg ZYPREXA 10/24/2011

Date of Submission

ANDA Approval Date

Approval Letter

0.05 mg /mL, 0.1 mg /mL and 0.5 mg/mL, 1 mL vials

SANDOSTATIN (PRESERVATIVE

FREE)

Prior to 12/8/2003

ANDA No. 076313

0.2 mg/mL and 1 mg /mL, 5 mL vials

Prior to 12/8/2003

ANDA No. 076330

0.05 mg/mL (base), 0.1 mg/mL (base) and 0.5 mg/mL (base) packaged in 1 mL pre-filled syringes (preservative free)

OCTREOTIDE ACETATE

INJECTION

Prior to 12/8/2003

ANDA No. 076527

2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg

Prior to 12/8/2003

ANDA No. 076000

Prior to 12/8/2003

ANDA No. 076133




DateApproval

Letter

Olanzapine ZYPREXA ZYDIS

Capsules 3 mg/25 mg SYMBYAX 5/8/2008

Capsules SYMBYAX 1/10/2005 6/19/2012

Olmesartan Medoxomil Tablets BENICAR 4/25/2006

Tablets BENICAR HCT 5/11/2007

Tablets BENICAR HCT 2/15/2007

Nasal Spray PATANASE 6/29/2009

0.10% PATANOL 7/17/2006

0.20% PATADAY 9/8/2008

Capsules 1 g LOVAZA 11/10/2008

Omeprazole PRILOSEC


5 mg, 10 mg, 15 mg and 20 mg

Prior to 12/8/2003

Olanzapine and Fluoxetine Hydrochloride

Olanzapine and Fluoxetine Hydrochloride

6 mg/25 mg, 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg

ANDA No. 077528


Olmesartan Medoxomil and Hydrochlorothiazide

20 mg/12.5 mg

Olmesartan Medoxomil and Hydrochlorothiazide

40 mg/12.5 mg and 40 mg/25 mg

Olopatadine Hydrochloride

0.665 mg/ Spray


Ophthalmic Solution


Ophthalmic Solution

Omega-3-Acid Ethyl Esters



Prior to 12/8/2003

11/16/2001 & 5/30/2008

ANDA No. 075347


http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75347ltr.PDF



DateApproval

Letter

Omeprazole PRILOSEC

Capsules ZEGERID 4/30/2007 5/25/2010

Capsules ZEGERID OTC 4/20/2010

ZEGERID 11/13/2007

ZEGERID 8/24/2007

Omeprazole Magnesium 20 mg PRILOSEC OTC 3/19/2007 6/5/2009

Injection ZOFRAN

Injection ZOFRAN

Injection

Oral Solution 4 mg/5 mL ZOFRAN 12/20/2004 12/26/2006



Prior to 12/8/2003

Omeprazole and Sodium Bicarbonate

20 mg/1100 mg and 40 mg/1100 mg

ANDA No. 078966


20 mg/1100 mg



20mg/1680mg per packet



40 mg/1680 mg per packet


ANDA No. 078878

Ondansetron Hydrochloride

2 mg/mL, 2 mL vials (Preservative free)

Prior to 12/8/2003



Prior to 12/8/2003


0.64 mg/mL, 50 mL container (plastic)

ZOFRAN IN PLASTIC CONTAINER

Prior to 12/8/2003


ANDA No. 076960




DateApproval

Letter

ZOFRAN ODT 12/26/2006

ZOFRAN ODT 11/24/2004 12/26/2006

Tablets ZOFRAN

12/26/2006

12/26/2006

Orlistat Capsules 60 mg ALLI 9/8/2010

Oseltamivir Phosphate Capsules TAMIFLU 8/2/2011

Oseltamivir Phosphate Capsule 75 mg TAMIFLU 11/15/2010

Oxaliplatin Injection ELOXATIN 2/9/2007

8/7/2009

8/7/2009

Oxaliplatin Injection ELOXATIN 3/23/2011



4 mg and 8 mg Prior to

12/8/2003ANDA No. 076506



16 mg and 24 mg

ANDA No. 077406


4 mg, 8 mg, 16 mg, and 24 mg

Prior to 12/8/2003

ANDA No. 076183

ANDA No. 076559

30 mg and 45 mg


ANDA No. 078812

ANDA No. 078813

5 mg/mL, 40 mL vial







DateApproval

Letter

Oxaliplatin For Injection ELOXATIN 2/9/2007

8/7/2009

8/7/2009

9/30/3009

Oxaliplatin Injection 200 mg/40 mL ELOXATIN 7/16/2007

Oxandrolone Tablets OXANDRIN 6/19/2006

Oxazepam Capsules SERAX

Oxcarbazepine Tablets TRILEPTAL 5/5/2006

10/9/2007

10/9/2007

11/15/2007

10/9/2007

12/11/2007

1/11/2008


ANDA No. 078810

ANDA No. 078818

ANDA No. 078815

2.5 mg and 10 mg


Prior to 12/8/2003

150 mg, 300 mg and 600 mg

ANDA No. 077794

ANDA No. 077795

ANDA No. 077801

ANDA No. 077802

ANDA No. 078005

ANDA No. 078069






DateApproval

Letter

Oxcarbazepine Oral Suspension 300 mg/5 mL TRILEPTAL 12/26/2006 6/26/2009

Oxybutynin 3.9 mg/24 hrs OXYTROL 8/19/2008

Oxybutynin Chloride DITROPAN XL

11/9/2006

11/9/2006

11/9/2006

Oxycodone

3/23/2004

15 mg 2/15/2007

1/3/2007

10 mg 10/25/2010

15 mg 10/28/2010

20 mg 10/29/2010

ANDA No. 078734

Transdermal System Extended-release



Prior to 12/8/2003

ANDA No. 076702

ANDA No. 076644

ANDA No. 076745


10 mg, 20 mg, 40 mg, 80 mg and 160 mg

OXYCONTIN (NDA 020553)

Prior to 12/8/2003

ANDA No. 076168

3/24/2004 (2/7/2007 - Converted to a Tentative Approval)

ANDA No. 075923

Oxycodone Hydrochloride





30 mg and 60 mg
















http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/075923s000TAltr.pdf



DateApproval

Letter

10/18/2010

40 mg 10/4/2010

Tablets OXECTA 2/8/2012

OPANA ER 11/23/2007 6/14/2010

OPANA ER 5/29/2008 12/13/2010

30 mg OPANA ER 6/12/2008 7/22/2010

5 mg 3/26/2012

3/23/2012

4/3/2012









5 mg and 7.5 mg

Oxymorphone Hydrochloride


5 mg, 10 mg, 20 mg and 40 mg

ANDA No. 079087



7.5 mg and 15 mg

ANDA No. 079046



ANDA No. 079087



OPANA ER (NDA 201655)



7.5 mg, 10 mg, and 15 mg




20 mg, 30 mg, 40 mg











Exclusivity Forfeited (Patent Expiration - FDC Act § 505(j)(5)(D)(i)(VI))

Exclusivity Granted (Pre-MMA; Shared Exclusivity) (Expiration 1/21/2009; 40 mg)

Exclusivity Relinquished (Pre-MMA; Shared Exclusivity) (10 mg, 20 mg)





See ANDA No. 75-410

FDA Letter Decision


Exclusivity Granted (Suitability Petition) (Expiration 6/7/2010) Suitability Petition - Docket No. 2004P-0373)



http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm120609.htm


Exclusivity Granted




Suitability Petition - FDA Docket No. 2004P-0056

Exclusivity Granted (Pre-MMA) (Expiration 6/24/2007; 4 mg, 8 mg, and 24, mg)


Suitability Petition - FDA Docket No. 2001P-0492

http://www.fda.gov/ohrms/dockets/dailys/04/july04/071204/04p-0056-pav00001-vol1.pdf

http://www.fda.gov/ohrms/dockets/dailys/02/Apr02/042202/01p-0492_pav0001_vol1.pdf





No Exclusivity Granted (Presumably Forfeited)





Exclusivity Granted (Shared) (Expiration4/6/2008)



Exclusivity Granted





Exclusivity Granted (Pre-MMA) (Expiration 12/4/2005; 10 mg, 20 mg, and 40 mg)


Exclusivity Granted





Paclitaxel Injection TAXOL 1/25/2002

Injection ALOXI 5/27/2011

Pamidronate Disodium For Injection AREDIA 4/30/2001

Pamidronate Disodium Injection AREDIA 6/27/2002

Pantoprazole Sodium For Injection 40 mg/vial PROTONIX IV 4/7/2005

Pantoprazole Sodium PROTONIX 2/2/2004

8/2/2007

9/10/2007

Paricalcitol Injection ZEMPLAR 11/28/2008 7/27/2011

Date of Submission

ANDA Approval Date

Approval Letter

6 mg/mL, 5 mL, 16.7 mL, 25 mL, 33.3 mL and 50 mL vials

Prior to 12/8/2003

ANDA No. 075184

Palonosetron Hydrochloride

0.05 mg/mL, 1.5 mL and 5 mL vials


Prior to 12/8/2003

ANDA No. 075290


Prior to 12/8/2003

ANDA No. 075841


20 mg and 40 mg

ANDA No. 077056

ANDA No. 077058

0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vials

ANDA No. 091108

http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75184_Paclitaxel_Approv.pdf


http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075841_s000_PamidronateTOC.cfm




DateApproval

Letter

Paricalcitol Capsules ZEMPLAR 10/14/2008

Paricalcitol Capsules 4 mcg ZEMPLAR 8/25/2008

Capsules PAXIL

Oral Suspension 10 mg/5 mL PAXIL 2/10/2005 12/4/2006

Tablets PAXIL 7/30/2003

PAXIL CR 9/9/2005 6/29/2007

37.5 mg PAXIL CR 5/19/2009 4/14/2011

Pemetrexed Disodium For Injection 100 mg/vial ALIMTA 7/1/2008

Pemetrexed Disodium For Injection 500 mg/vial ALIMTA 2/4/2008

Pemetrexed disodium For Injection 1000 mg/vial ALIMTA 6/27/2012

Pergolide Mesylate Tablets PERMAX 11/27/2002

Perindopril Erbumine Tablets ACEON 6/6/2006

Tablets ACTOS

8/17/2012

1 mcg and 2 mcg

Paroxetine Hydrochloride 10 mg and 20 mg

Prior to 12/8/2003

Paroxetine Hydrochloride ANDA No.

077395

Paroxetine Hydrochloride 10 mg, 20 mg, 30 mg and 40 mg

Prior to 12/8/2003

ANDA No. 075356

Paroxetine Hydrochloride


12.5 mg and 25 mg

ANDA No. 077873

Paroxetine Hydrochloride Extended-release Tablets

ANDA No. 091427

0.05 mg, 0.25 mg and 1 mg

Prior to 12/8/2003

ANDA No. 076061

2 mg, 4 mg and 8 mg

Pioglitazone Hydrochloride


Prior to 12/8/2003

ANDA No. 076801

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75356ap.pdf






DateApproval

LetterTablets ACTOS

Tablets DUETACT 12/22/2009 1/4/2013

ACTOPLUS MET XR 9/23/2011

Tablets ACTOPLUS MET 3/6/2008

For Injection ZOSYN 9/15/2009

For Injection 40.5 g/vial ZOSYN 9/15/2009

For Injection ZOSYN 12/6/2011

17g/Scoopful MIRALAX

7/30/2010

Pioglitazone Hydrochloride


Prior to 12/8/2003

ANDA No. 076800

Pioglitazone Hydrochloride and Glimepiride


ANDA No. 201049

Pioglitazone Hydrochloride and Metformin Hydrochloride


15 mg/1000 mg and 30 mg/1000 mg

Pioglitazone Hydrochloride and Metformin Hydrochloride

15 mg/500 mg and 15 mg/850 mg

6/26/2012 (Initially approved

on 2/25/2011)

ANDA No. 090406

Piperacillin Sodium and Tazobactam Sodium

2.25 g/vial, 3.375 g/vial, 4.5 g/vial


2/5/2009ANDA No. 065386



2/5/2009ANDA No. 065446


12 g/1.5 g per vial (pharmacy bulk)

Polyethylene Glycol 3350 Powder for Oral Solution

Prior to 12/8/2003

Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl

For Oral Solution and Delayed-release Tablet

210 g, 5.6 g, 0.74 g, 2.86 g and 5 mg (1 Tablet Regimen)

HALFLYTELY AND BISACODYL





DateApproval

Letter

1/28/2008

For Oral Solution MOVIPREP 11/27/2007

Posaconazole Oral Suspension 40 mg/mL NOXAFIL 2/28/2011

Potassium Chloride MICRO K

Potassium Chloride K-DUR 11/20/1998

Potassium Chloride 15 mEq K-DUR 6/6/2003

Tablets MIRAPEX 6/24/2005 2/19/2008

Tablets 0.25 mg MIRAPEX 5/27/2005 2/19/2008

Tablets 0.75 mg MIRAPEX 7/31/2008 4/9/2010

Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride and Bisacodyl

For Oral Solution and Delayed-release Tablets

210 g, 5.6 g, 0.74 g, 2.86 g and 5 mg (2 Tablet Regimen)

HALFLYTELY AND BISACODYL

Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid

100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch


8 mEq and 10 mEq

Prior to 12/8/2003


10 mEq and 20 mEq

Prior to 12/8/2003

ANDA No. 074726


Prior to 12/8/2003

ANDA No. 074726

Pramipexole Dihydrochloride

0.125 mg, 0.5 mg, 1 mg and 1.5 mg

ANDA No. 077724


ANDA No. 077724


ANDA No 090764






DateApproval

Letter

MIRAPEX ER 6/1/2010

MIRAPEX ER 7/26/2011

Pravastatin Sodium Tablets PRAVACHOL

4/24/2006

4/23/2007

Pravastatin Sodium Tablets 30 mg PRAVACHOL 6/1/2005 11/21/2006

Prazosin Hydrochloride Capsules MINIPRESS

Oral Solution PEDIAPRED

6/28/2002

12/14/2000

ORAPRED 7/22/2010

Pregabalin Capsules LYRICA 12/30/2008

7/3/2012



0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg



2.25 mg and 3.75 mg

10 mg, 20 mg, 40 mg and 80 mg

Prior to 12/8/2003

ANDA No. 076056

ANDA No. 076445

ANDA No. 077730

1 mg, 2 mg and 5 mg

Prior to 12/8/2003

Prednisolone Sodium Phosphate

5 mg(base)/ 5 mL and 15 mg (base)/ 5 mL

Prior to 12/8/2003

ANDA No. 075099

ANDA No. 075117

Prednisolone Sodium Phosphate



25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg

ANDA No. 091040


http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75099APltr.PDF





DateApproval

Letter

Pregabalin Capsules LYRICA 12/30/2008

7/3/2012

7/3/2012

7/3/2012

Pregabalin Oral Solution 20 mg/mL LYRICA 5/19/2010

Propafenone 325 mg RYTHMOL SR 11/7/2006

RYTHMOL SR 10/11/2006 10/18/2010

Propofol Injection DIPRIVAN 1/4/1999

INDERAL LA

25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg

ANDA No. 091219

ANDA No. 091221

ANDA No. 091224


Propafenone Hydrochloride


225 mg and 425 mg

ANDA No. 078540

10 mg/mL ; 20 mL, 50 mL and 100 mL vials and 20 mL syringe

Prior to 12/8/2003

ANDA No. 075102

Propranolol Hydrochloride


60 mg, 80 mg, 120 mg and 160 mg

Prior to 12/8/2003





http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75102_Propofol.pdf





Exclusivity Forfeited

Exclusivity Granted


Exclusivity Granted (Pre-MMA) (Expiration 5/5/2002; 30 mg/vial & 90 mg/vial)

Suitability Petition - Docket Nos. 1999P-2252 & 2000P-0091; See ANDA No. 76-153



http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76153.AP.pdf







FDA Letter Decision




Exclusivity Forfeited - Patent Expiration FDC Act § 505(j)(5)(D)(i)(VI))

Exclusivity Granted (pre-MMA) (Expiration 2/13/2013)

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm120608.htm


Exclusivity Granted

Exclusivity Granted (pre-MMA) - Triggered by Authorized Generic marketing

Exclusivity selectively waived - ANDA No. 202467

Exclusivity Granted (Expiration 2/13/2013); FDA initially determined 180-day exclusivity was forfeited for Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV)), but reversed the decision.

See FDA 2/25/2011 ANDA Approval Letter

Exclusivity Granted (Expiration 3/30/2010; 2.25 g/vial) (Expiration 3/28/2010; 3.375 g/vial) (Expiration 3/21/2010 4.5 g/vial)






No Exclusivity Presumably Granted (Pre-MMA)


Tentative Approval(s) Granted, but RLD Withdrawn for Safety Reasons; No Exclusivity

Exclusivity Granted (Pre-MMA) (Expiration 2/28/2002; 20 mEq strength)





Exclusivity Granted (Shared) (all strengths)

Exclusivity Granted (Pre-MMA) (Expiration 10/21/2006; 10 mg, 20 mg, and 40 mg)


Exclusivity Presumably Granted - Suitability Petition - Docket No. 2004P-0216

Exclusivity Granted (Pre-MMA) (5 mg(base)/5 mL)

Exclusivity Granted (Pre-MMA) (Expiration 7/2/2001; 15 mg (base)/5 mL) (Suitability Petition ANDA)



Exclusivity Forfeited (25 mg and 50 mg strengths) - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))

Exclusivity Forfeited (all strengths) - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))

Exclusivity Forfeited (75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg strengths) - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV))





Quetiapine Fumarate Tablets 25 mg SEROQUEL 8/12/2005

Quetiapine Fumarate 400 mg SEROQUEL XR 6/18/2008


Quetiapine Fumarate Tablets SEROQUEL 2/12/2007

Quetiapine Fumarate Tablets SEROQUEL 2/21/2006

Quetiapine Fumarate SEROQUEL XR 6/12/2008


Quinapril Hydrochloride Tablets ACCUPRIL

Tablets ACCURETIC 3/31/2004

Date of Submission

ANDA Approval Date

Approval Letter



50 mg, 150 mg and 400 mg

100 mg, 200 mg and 300 mg


200 mg and 300 mg


5 mg, 10 mg, 20 mg and 40 mg

Prior to 12/8/2003


Tentative Approval

4/11/2005; Reapproved 8/24/2007)

ANDA No. 075504

Quinapril Hydrochloride/ Hydrochlorothiazide

10 mg/12.5 mg, 20 mg/12.5 mg and 20mg/25 mg

Prior to 12/8/2003

ANDA No. 076374


http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76374.ltr.pdf



DateApproval

Letter











Exclusivity Later Relinquished- See ANDA No. 076607





Rabeprazole Sodium 20 mg ACIPHEX 2/21/2007

Regadenoson Injection LEXISCAN 4/10/2012

Raltegravir Tablets 400 mg ISENTRESS 10/12/2011

Tablets 60 mg EVISTA

Ramelteon Tablets 8 mg ROZEREM 7/22/2009

Ramipril Capsules ALTACE

10/24/2005

6/9/2008

Ranitidine Capsules ZANTAC 10/22/1997

Ranitidine Injection ZANTAC

Date of Submission

ANDA Approval Date

Approval Letter


Prior to 12/8/2003

ANDA No. 076822


Raloxifene Hydrochloride Prior to

12/8/2003

1.25 mg, 2.5 mg, 5 mg and 10 mg

Prior to 12/8/2003

ANDA No. 076549

ANDA No. 077626

150 mg and 300 mg

Prior to 12/8/2003

ANDA No. 074655

25 mg/mL, 2 mL and 6 mL and 40 mL vials

Prior to 12/8/2003




http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/74655_Ronitidine_Approv.pdf



DateApproval

Letter

Ranitidine Oral Solution 15 mg/mL ZANTAC 2/21/2007

Ranitidine Tablets ZANTAC

6/21/1999

8/22/1997

Ranitidine Hydrochloride Tablets 150 mg 10/30/2007

Ranolazine RENEXA 5/17/2010

Rasagiline Mesylate Tablets AZILECT 5/17/2010

Repaglinide Tablets PRANDIN 2/10/2005

Tablets PRANDIMET 4/9/2009

Ribavirin Capsules 200 mg REBETOL

4/6/2004

4/6/2004

Risedronate Sodium Tablets ACTONEL 4/23/2004 10/5/2007

Risedronate Sodium Tablets 75 mg ACTONEL 9/10/2007

Prior to 12/8/2003

ANDA No. 076124

75 mg, 150 mg and 300 mg

Prior to 12/8/2003

ANDA No. 075094

ANDA No. 074023

ZANTAC 150 (NDA 21698/PRODUCT

002)


500 mg and 1000 mg

0.5 mg and 1 mg


Repaglinide and Metformin Hydrochloride


Prior to 12/8/2003

ANDA No. 076203

ANDA No. 076192


ANDA No. 077132


http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75094ta.pdf






DateApproval

Letter

Risedronate Sodium Tablets 150 mg ACTONEL 8/12/2008

Risedronate Sodium 35 mg ATELVIA 7/19/2011

Tablets 12/18/2007

Risperidone Oral Solution 1 mg/mL RISPERDAL 1/30/2009

Risperidone Tablets RISPERDAL 6/30/2008

Risperidone 0.25 mg RISPERDAL 4/11/2005 4/30/2009

Risperidone RISPERDAL

Risperidone RISPERDAL 3/23/2005 4/30/2009

Ritonavir Tablets 100 mg NORVIR 12/21/2010

Rivastigmine Tartrate Capsules EXELON 4/21/2004

10/22/2007

10/22/2007


Risedronate Sodium with Calcium Carbonate

35 mg; 500 mg ACTONEL WITH

CALCIUM

Prior to 12/8/2003

ANDA No. 076440

0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg

Prior to 12/8/2003

ANDA No. 076228


ANDA No. 077494



Likely On or After

12/8/2003


3 mg and 4 mg

ANDA No. 077494

1.5 mg, 3 mg, 4.5 mg and 6 mg

ANDA No. 077130

ANDA No. 077131






DateApproval

Letter

Rivastigmine Tartrate Capsules EXELON 4/21/2004

1/8/2008

Rivastigmine Tartrate Oral Solution 2 mg/mL EXELON 11/5/2004

Rivastigmine EXELON PATCH 4/27/2011

Rizatriptan Benzoate Tablets MAXALT 9/2/2004 12/31/2012

Rizatriptan Benzoate MAXALT-MLT 2/17/2006 12/31/2012

Rofecoxib Tablets VIOXX

Ropinirole Hydrochloride 2 mg REQUIP XL 10/14/2008 5/17/2012




Tablets REQUIP 12/22/2004

1.5 mg, 3 mg, 4.5 mg and 6 mg

ANDA No. 077129

Transdermal System Extended-release

4.6 mg/24 hr and 9.5 mg/24 hr

5 mg and 10 mg

ANDA No. 077263


5 mg and 10 mg

ANDA No. 078173

12.5 mg, 25 mg and 50 mg

Prior to 12/8/2003


ANDA No. 090869


ANDA No. 090869


ANDA No. 090869


ANDA No. 090869

Ropinirole Hydrochloride 0.25 mg, 0.5 mg, 1 mg and 2 mg







DateApproval

Letter

Ropinirole Hydrochloride Tablets REQUIP 2/4/2005

3 mg REQUIP XL 1/8/2009

12 mg REQUIP XL 2/5/2009 5/17/2012

Injection NAROPIN 11/13/2006

Rosiglitazone Maleate Tablets AVANDIA 1/25/2013

Tablets AVANDAMET 10/22/2004

Rosuvastatin Calcium Tablets CRESTOR 8/13/200

3 mg, 4 mg and 5 mg

Ropinirole Hydrochloride Extended-release Tablets

Ropinirole Hydrochloride Extended-release Tablets

ANDA No. 090869

Ropivacaine Hydrochloride

2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials

2 mg, 4 mg and 8 mg

Prior to 12/8/2003

ANDA No. 076747

Rosiglitazone Maleate and Metformin Hydrochloride

1 mg/ 500 mg, 2 mg/ 500mg, 4 mg/ 500 mg, 2 mg/ 1000 mg and 4 mg/ 1000 mg

5 mg, 10 mg, 20 mg and 40 mg 7




Exclusivity Granted (Pre-MMA; Shared)




FDA Letter Decision

Exclusivity Granted (Pre-MMA) (Expiration 12/7/2008) (Second period granted based on new patent(s))

Exclusivity Lost (Pre-MMA) - Patent Expiration





Exclusivity Granted


Exclusivity Granted (Pre-MMA) - (Expiration 1/14/2000; 75 mg strength)

Exclusivity Granted (Pre-MMA) and Selectively Waived - (Expiration 8/29/1997; 150 mg & 300 mg strengths)

See Docket No. 2004P-0227

Exclusivity Presumably Forfeited (Patent Expiration - FDC Act § 505(j)(5)(D)(i)(VI))



http://www.fda.gov/ohrms/dockets/dailys/04/july04/070704/04p-0227-pdn0001.pdf







Exclusivity Relinquished (1 mg)






Exclusivity Granted




Exclusivity Granted (Expiration 6/6/2012) (Patent Expired on 6/6/2012) (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV))







Exclusivity Granted (pre-MMA)




Exclusivity Granted (Expired 6/6/2012 Upon Patent Expiration)



Sertraline Hydrochloride Oral Concentrate 20 mg/mL ZOLOFT 12/8/2003 6/30/2006

Sertraline Hydrochloride Tablets ZOLOFT 6/30/2006

Sertraline Hydrochloride Tablets ZOLOFT 11/9/2005 2/6/2007

Sevelamer Carbonate Tablets 800 mg RENVELA 12/4/2008

Sevelamer Carbonate RENVELA 12/30/2009

Tablets RENAGEL 5/22/2008

Sevoflurane Inhalation 100%, 250 mL ULTANE

7/2/2002

5/2/2007

Capsules MERIDIA 8/14/2009

Sildenafil Citrate Tablets VIAGRA 11/19/2004

Sildenafil Citrate Tablets 100 mg VIAGRA 10/25/2004

Date of Submission

ANDA Approval Date

Approval Letter

ANDA No. 076934

25 mg, 50 mg and 100 mg

Prior to 12/8/2003

ANDA No. 075719

150 mg and 200 mg

ANDA No. 077977


0.8 g/packet and 2.4 g/packet

Sevelamer Hydrochloride 400 mg and 800 mg

Prior to 12/8/2003

ANDA No. 075895

ANDA No. 077867

Sibutramine Hydrochloride

10 mg and 15 mg

25 mg and 50 mg


http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/75719%20APltr.pdf


http://www.sec.gov/Archives/edgar/data/1121225/000095015207004016/l26032aexv99w2.htm



DateApproval

Letter

Silver Sulfadiazine Cream 1% SILVADENE

Simvastatin Tablets ZOCOR

6/23/2006

6/23/2006

Sirolimus Tablets 0.5 mg RAPAMUNE 8/25/2010

Sirolimus Tablets RAPAMUNE 12/17/2009

Tablets OSMOPREP 4/9/2008

Sodium Oxybate Oral Solution 500 mg/mL XYREM 7/8/2010

Oral Solution 11/8/2010

Solifenacin Succinate Tablets VESICARE 4/8/2009

Sitagliptin Phosphate Tablets JANUVIA 10/18/2010

Tablets JANUMET 10/18/2010

Prior to 12/8/2003

5 mg, 10 mg, 20 mg, 40 mg and 80 mg

Prior to 12/8/2003

ANDA No. 076052

ANDA No. 076285

1 mg and 2 mg

Sodium Phosphate Monobasic Monohydrate and Sodium PhosphateDibasic Anhydrous, USP

1.102 g and 0.398 g

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate

17.5 g/3.13 g/1.6 g per bottle

SUPREP BOWEL PREP KIT

5 mg and 10 mg

25 mg, 50 mg and 100 mg

Sitagliptin Phosphate and Metformin Hydrochloride

50 mg/500 mg and 50 mg/1000 mg





DateApproval

Letter

JANUMET XR 3/16/2012

JANUMET XR 10/22/2012

Tablets JUVISYNC 6/19/2012

Tablets JUVISYNC 6/25/2012

Sumatriptan Succinate Injection IMITREX 10/25/2004

Sumatriptan Succinate Injection IMITREX 5/9/2006

Sumatriptan Succinate Tablets IMITREX

2/9/2009

2/9/2009

Sunitinib Malate Capsules SUTENT 1/26/2010



50 mg/500 mg and 50 mg/1000 mg



100 mg/1000 mg

Sitagliptin and Simvastatin Phosphate

100 mg/10 mg and 100 mg/40 mg

Sitagliptin and Simvastatin Phosphate

100 mg/10 mg and 100 mg/40 mg

6 mg/0.5 mL, 0.5 mL vials

6 mg/0.5 mL, 0.5 mL (prefilled syringes)

25 mg, 50 mg and 100 mg

Prior to 12/8/2003

ANDA No. 076572

ANDA No. 076840

12.5 mg, 25 mg, 37.5 mg and 50 mg











Exclusivity Granted (Pre-MMA) (Second period)




Exclusivity Granted (Pre-MMA) (Expiration 12/20/2006; 5 mg, 10 mg, 20 mg, and 40 mg) Petition Decision - Docket Nos. 2005P-0008 & 2005P-0046


http://www.fda.gov/ohrms/dockets/dockets/05p0008/05p-0008-pdn0001-vol2.pdf




Exclusivity Granted (Pre-MMA; Shared) (Expiration 8/8/2009; 100 mg)

Exclusivity Granted (Pre-MMA; Shared) (Expiration 8/8/2009; 25 mg, 50 mg, and 100 mg)



Tacrolimus Ointment 0.03% PROTOPIC 11/22/2010

Tacrolimus Ointment 0.10% PROTOPIC 9/9/2010

Tadalafil Tablets 2.5 mg x CIALIS 10/14/2008

Tadalafil Tablets CIALIS 11/21/2007

Tadalafil Tablets 20 mg ADCIRCA 10/15/2009

Tamoxifen Citrate Tablets NOLVADEX 2/20/2003

Capsules 0.4 mg FLOMAX 12/20/2004

Telmisartan Tablets MICARDIS 12/26/2006

Tablets MICARDIS HCT 12/31/2008

Tablets 80 mg/25 mg MICARDIS HCT 2/27/2009

Temazepam Capsules 7.5 mg RESTORIL 11/1/2006 9/8/2009

Date of Submission

ANDA Approval Date

Approval Letter


10 mg and 20 mg

Prior to 12/8/2003

ANDA No. 070929

Tamsulosin Hydrochloride


Telmisartan and Hydrochlorothiazide

80 mg/12.5 mg and 40 mg/12.5 mg

Telmisartan and Hydrochlorothiazide

ANDA No. 078581



DateApproval

Letter

Temozolomide Capsules TEMODAR 3/20/2007 3/1/2010

Temozolomide Capsules TEMODAR 3/24/2008 3/1/2010

Temsirolimus Injection TORISEL 5/25/2011

Tablets 300 mg VIREAD 1/26/2010

Tablets VIREAD 5/17/2012

Terazosin Hydrochloride Capsules HYTRIN 3/30/1998

Terazosin Hydrochloride Tablets HYTRIN 12/31/1998

Tablets 250 mg LAMISIL

Terfenadine Tablets 60 mg SELDANE

Testosterone Gel 1% ANDROGEL 1/27/2006

Testosterone Gel 1% TESTIM 8/21/2008

Testosterone 1% ANDROGEL 12/19/2008

Testosterone Gel 2% ANDROGEL 4/6/2012

5 mg, 20 mg, 100 mg, and 250 mg

ANDA No. 078879

140 mg and 180 mg

ANDA No. 078879

25 mg/mL, 1.8 mL vial

Tenofovir Disoproxil Fumarate

Tenofovir Disoproxil Fumarate

150 mg, 200 mg, and 250 mg


Prior to 12/8/2003

ANDA No. 074823


Prior to 12/8/2003

ANDA No. 074315

Terbinafine Hydrochloride

Prior to 12/8/2003

Prior to 12/8/2003

Prior to 12/8/2003

ANDA No. 076737

Gel Metered-dose Pump

http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74823ap.pdf

http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-315_Terazosin%20Hydrochloride_Approv.pdf




DateApproval

Letter

Testosterone Gel FOTESTA 8/14/2012

Thalidomide Capsules THALOMID 12/18/2006

Thalidomide Capsules 200 mg THALOMID 9/25/2006

Tiagabine Hydrochloride Tablets GABITRIL 2/1/2005 11/4/2011

Tablets 250 mg TICLID 7/1/1999

Tigecycline For Injection 50 mg per vial TYGACIL 6/15/2009

Timolol Maleate TIMOPTIC

Capsules ZANAFLEX 8/10/2007 2/3/2012

Tobramycin Inhalation Solution 300 mg/5 mL TOBI 6/29/2009

Tolterodine Tartrate DETROL LA 7/30/2007

Tolterodine Tartrate Tablets DETROL

Topiramate Capsules 9/7/2005

4/15/2009

4/15/2009

10 mg/actuation

50 mg and 100 mg

2 mg and 4 mg

ANDA No. 077555

Ticlopidine Hydrochloride Prior to

12/8/2003ANDA No. 075089

Ophthalmic Solution 0.25% and 0.5%

Prior to 12/8/2003

Tizanidine Hydrochloride 2 mg, 4 mg and 6 mg

ANDA No. 078868


2 mg and 4 mg

1 mg and 2 mg Likely On or

After 12/8/2003

ANDA No. 076953

15 mg and 25 mg

TOPAMAX SPRINKLE

ANDA No. 076448

ANDA No. 077868








DateApproval

Letter

Topiramate Capsules 9/7/2005

4/15/2009

Topiramate Tablets TOPAMAX 12/26/2001

Topiramate Tablets 50 mg TOPAMAX 9/8/2005

Torsemide Tablets DEMADEX 5/14/2002

Tramadol Hydrochloride Tablets 50 mg ULTRAM

Tramadol Hydrochloride 100 mg ULTRAM ER 1/8/2007 11/13/2009

Tramadol Hydrochloride 200 mg ULTRAM ER 3/28/2007 11/13/2009

Tramadol Hydrochloride 300 mg ULTRAM ER 9/25/2007

Tramadol Hydrochloride RYZOLT 6/18/2009 12/30/2011

Trandolapril Tablets MAVIK 10/4/2004

15 mg and 25 mg

TOPAMAX SPRINKLE

ANDA No. 077868

25 mg, 100 mg and 200 mg


Tentative Approval on

7/27/2007 and Back to final Approval on 3/27/2009)

ANDA No. 076314

5 mg, 10 mg, 20 mg, and 100 mg

Prior to 12/8/2003

ANDA No. 076110

Prior to 12/8/2003


ANDA No. 078783


ANDA No. 078783



100 mg, 200 mg and 300 mg

ANDA No. 091607

1 mg, 2 mg and 4 mg




http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078783s000(2)ltr.pdf

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078783s000(2)ltr.pdf

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091607Orig1s000Approv.pdf



DateApproval

Letter

TARKA 11/9/2007 5/26/2010

1 mg/240 mg TARKA 2/20/2008 8/30/2010

4 mg/ 240 mg TARKA 7/24/2007 5/5/2010

Tranexamic Acid Tablets 650 mg LYSTEDA 5/24/2011 12/27/2013

Travoprost 0.0040% TRAVATAN 11/28/2008

Travoprost (Preserved) 0.0040% TRAVATAN Z 2/19/2009

Tablets 150 mg DESYREL

OLEPTRO 10/18/2010

Treprostinil Sodium Injection REMODULIN 12/2/2011

Tretinoin Cream RETIN-A

Tretinoin Gel 0.025% RETIN-A

Tretinoin Gel 0.040% RETIN-A MICRO 12/20/2010

Tretinoin Gel 0.100% RETIN-A MICRO 7/8/2010

Trandolapril and Verapamil Hydrochloride



ANDA No. 079135



ANDA No. 079135



ANDA No. 079135

ANDA No. 202093

Ophthalmic Solution

Ophthalmic Solution

Trazodone Hydrochloride Prior to

12/8/2003

Trazodone Hydrochloride Extended-release Tablets

150 mg and 300 mg


0.025%, 0.05% and 0.1%

Prior to 12/8/2003

Prior to 12/8/2003






DateApproval

Letter

Triamcinolone Acetonide Nasal Spray NASACORT AQ 12/29/2005 7/30/2009

Tablets MAXZIDE

Trospium Chloride 60 mg SANCTURA XR 3/2/2009 10/12/2012

0.055 mg/Spray

ANDA No. 078104

Triamterene/ Hydrochlorothiazide

37.5 mg/25 mg and 75 mg/50 mg

Prior to 12/8/2003


ANDA No. 091289









No Exclusivity Granted (Pre-MMA) - Change from PIV to PIII; Petition Decision (1998P-0493) & Court Decision (Mylan Pharmaceuticals, Inc. v. Henney, 94 F. Supp. 2d 36 (D.D.C. 2000))



Exclusivity Granted


Exclusivity Granted


Exclusivity Granted & Relinquished (Pre-MMA) FTC Order

No Exclusivity Granted (Pre-MMA) - Patent Expiration

No Exclusivity Granted (Pre-MMA) (RLD Approval Withdrawn for Reasons of Safety)

Exclusivity Granted (Pre-MMA) (subsequently relinquished)

http://www.ftc.gov/os/caselist/c3946.shtm


Exclusivity Granted



Exclusivity Granted (Pre-MMA) (Exclusivity Voided by Later Court Decision)



Exclusivity Granted (Pre-MMA/MMA-Straddle) (Expiration 10/12/2009)

Exclusivity Selectively Waived - ANDA No. 076575

FDA Letter Decision

Exclusivity Granted (Pre-MMA/MMA-Straddle) (Expiration 10/12/2009)

http://www.tevagenerics.com/assets/base/products/fda/Topi_76-575.pdf

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CenterforDrugEvaluationandResearch/UCM135323.pdf




Exclusivity Granted

Exclusivity Granted

Exclusivity Presumably Forfeited

FDA Letter Decision

Exclusivity Granted (Pre-MMA) (Expiration 2/17/2003; 5 mg strength) (Expiration 12/10/2002; 10 mg & 100 mg strengths) (Expiration 12/7/2002; 20 mg strength)

Presumably No Exclusivity Granted - Conversion from PIV to section viii Statement


http://www.fda.gov/downloads/AboutFDA/CentersOffices/CenterforDrugEvaluationandResearch/UCM135323.pdf


Exclusivity Granted









Exclusivity Granted/Forfeited (180-Day Punt) - Failure to Obtain Tentative Approval in 30 Months (FDC Act § 505(j)(5)(D)(i)(IV)) (Expiration 04/10/2013)




DateApproval

Letter



Tablets VALTREX 1/31/2007

For Oral Solution 50 mg/mL VALCYTE 3/21/2011

Tablets 450 mg VALCYTE 12/27/2005

Valsartan Tablets DIOVAN 12/28/2004

Tablets DIOVAN HCT 12/2/2005 9/21/2012

Tablets DIOVAN HCT 2/7/2007 9/21/2012

Tablets 2.5 mg LEVITRA 9/4/2009

Tablets LEVITRA 7/10/2009

Vardenafil Hydrochloride Tablets 20 mg LEVITRA 3/5/2009

Vardenafil Hydrochloride 10 mg STAXYN 12/22/2011

Date of Submission

ANDA Approval Date

Approval Letter

Valacyclovir Hydrochloride

500 mg and 1000 mg

Prior to 12/8/2003

ANDA No. 076588

Valganciclovir hydrochloride

Valganciclovir Hydrochloride

40 mg, 80 mg, 160 mg and 320 mg

ANDA No. 077492

Valsartan and Hydrochlorothiazide

80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg

ANDA No. 078020

Valsartan and Hydrochlorothiazide

320 mg/12.5 mg and 320 mg/25 mg

ANDA No. 078020

Vardenafil Hydrochloride

Vardenafil Hydrochloride 5 mg and 10 mg






DateApproval

Letter

Varenicline Tartrate Tablets CHANTIX 5/10/2010

Vecuronium Bromide For Injection NORCURON

EFFEXOR XR 6/28/2010

Tablets EFFEXOR 11/3/2005 8/3/2006

EFFEXOR XR 5/3/2007

2/12/2009 8/18/2010

225 mg Venlafaxine 1/10/2011

VERELAN PM 7/20/2006

VERELAN SR

180 mg

240 mg COVERA HS

0.5 mg and 1 mg


Prior to 12/8/2003

Venlafaxine Hydrochloride


37.5 mg, 75 mg and 150 mg

Prior to 12/8/2003

ANDA No. 076565


25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg

ANDA No. 076690



37.5 mg, 75 mg and 150 mg



37.5 mg, 75 mg and 150 mg

VENLAFAXINE HYDROCHLORIDE

ANDA No. 091272

Venlafaxine hydrochloride


Verapamil Hydrochloride Extended-release Capsules

100 mg and 200 mg


120 mg, 180 mg and 240 mg

Prior to 12/8/2003

Verapamil Hydrochloride Extended-release Tablets

ISOPTIN SR (CALAN SR)

Prior to 12/8/2003

Verapamil Hydrochloride Extended-release Tablets

Likely On or After

12/8/2003





DateApproval

Letter

300 mg VERELAN PM 5/19/2006

Vincristine Sulfate Injection ONCOVIN

Voriconazole For Injection 200 mg/vial VFEND 9/12/2008

Voriconazole Tablets VFEND 4/14/2008 4/22/2010

Voriconazole Oral Suspension 40 mg/mL VFEND 10/8/2010


1 mg/mL, 1 mL, 2 mL and 5 mL vials

Prior to 12/8/2003

50 mg and 200 mg

ANDA No. 090547






Exclusivity Expected (Failure to Obtain Tentative Approval in 30 Months Exception Applied - FDC Act § 505(j)(5)(D)(i)(IV))









No Exclusivity Granted (New RLD with Approval of NDA No. 22-104 - PIV submitted 2/12/2009)

Exclusivity Granted




Exclusivity Granted




DateApproval

Letter



Zafirlukast Tablets ACCOLATE 2/29/2008 11/15/2010

Zaleplon Capsules SONATA 6/21/2005

Zidovudine Capsules 100 mg RETROVIR

Capsules GEODON 2/7/2005

3/2/2012

3/2/2012

3/2/2012

Zoledronic Acid Injection RECLAST 8/29/2008

Zoledronic Acid Injection ZOMETA 6/11/2008

Zoledronic Acid Injection ZOMETA 1/31/2012

Zolpidem Tartrate Sublingual Tablets EDLUAR 4/29/2010

Date of Submission

ANDA Approval Date

Approval Letter

10 mg and 20 mg

ANDA No. 090372

5 mg and 10 mg

Ziprasidone Hydrochloride

20 mg, 40 mg, 60 mg and 80 mg

ANDA No. 077560

ANDA No. 077561

ANDA No. 077565


0.8 mg (base) /mL

4 mg/100 mg, 100 mL vial

5 mg and 10 mg




DateApproval

Letter

Zolpidem Tartrate 6.25 mg AMBIEN CR 2/24/2006 10/13/2010

Zolpidem Tartrate 12.5 mg AMBIEN CR 1/19/2006 12/3/2010

Zolpidem Tartrate Sublingual Tablets INTERMEZZO 4/10/2012


ANDA No. 078179


ANDA No. 078148

1.75 mg and 3.5 mg





Exclusivity Granted








FDA Letter Decision

http://www.hpm.com/pdf/blog/ZOMETA%20-%20FDA%20Forfeiture%20Ltr%20Decision.pdf

180-Day Exclusivity Tracker

Documents

Transcript of 180-Day Exclusivity Tracker