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Drug company (FDA labeler)

Bryant Ranch Prepack

NDC labeler codes: 63629, 71335, 72162, 83615

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

4,078Products (NDC)

Prescription medicines

FDA applications for these products

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
April 6, 2026ANDA211541 Dapagliflozin
DAPAGLIFLOZIN
Teva Pharms USA
December 18, 2025ANDA218162 Haloperidol
HALOPERIDOL
Creekwood Pharms
December 18, 2025ANDA218756 Nitroglycerin
NITROGLYCERIN
Amvika
November 10, 2025ANDA217862 Ropinirole
ROPINIROLE HYDROCHLORIDE
Elite Labs Inc
September 4, 2025ANDA218755 Paliperidone
PALIPERIDONE
Pharmazone
February 11, 2025ANDA212694 Benztropine mesylate
BENZTROPINE MESYLATE
Quagen
October 1, 2024ANDA217397 Nebivolol
NEBIVOLOL HYDROCHLORIDE
Msn
September 19, 2024ANDA218531 Enalapril maleate
ENALAPRIL MALEATE
Unique Pharm
September 12, 2024ANDA218936 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Rising
August 20, 2024ANDA209610 Clindamycin phosphate and benzoyl peroxide
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Padagis Israel
August 6, 2024ANDA217400 Famotidine
FAMOTIDINE
Msn
July 26, 2024ANDA214110 Metoprolol
METOPROLOL SUCCINATE
Zhejiang Jutai Pharm
July 15, 2024ANDA217075 Tazarotene
TAZAROTENE
Padagis Israel
July 10, 2024ANDA212696 Glycopyrrolate
GLYCOPYRROLATE
Quagen
June 11, 2024ANDA218320 Tranexamic acid
TRANEXAMIC ACID
Rubicon Research
June 3, 2024ANDA217552 Methotrexate
METHOTREXATE SODIUM
Alembic
June 3, 2024ANDA218462 Tofacitinib
TOFACITINIB CITRATE
Aurobindo Pharma Ltd
May 21, 2024ANDA216474 Sucralfate
SUCRALFATE
Strides Pharma
May 6, 2024ANDA215329 Scopolamine
SCOPOLAMINE
Rhodes Pharms
April 29, 2024ANDA215463 Colchicine
COLCHICINE
Aurobindo Pharma Ltd
April 29, 2024ANDA218411 Lidocaine
LIDOCAINE HYDROCHLORIDE
The J Molner
April 19, 2024ANDA218789 Haloperidol
HALOPERIDOL
Aurobindo Pharma Ltd
April 5, 2024ANDA212684 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Strides Pharma
March 12, 2024ANDA216376 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Quagen
February 14, 2024ANDA217782 Oxcarbazepine
OXCARBAZEPINE
Pharmazone
February 13, 2024ANDA217118 Atorvastatin
ATORVASTATIN CALCIUM
Aurobindo Pharma Ltd
February 7, 2024ANDA216282 Dexamethasone
DEXAMETHASONE
Zydus Lifesciences
January 22, 2024ANDA210961 Chlorzoxazone
CHLORZOXAZONE
Pharmazone
January 22, 2024ANDA214513 Atorvastatin
ATORVASTATIN CALCIUM
Laurus
January 22, 2024ANDA217917 Fluvoxamine maleate
FLUVOXAMINE MALEATE
Bionpharma
January 18, 2024ANDA214287 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Quagen
December 22, 2023ANDA215379 Lacosamide
LACOSAMIDE
Msn
December 22, 2023ANDA217919 Icosapent ethyl
ICOSAPENT ETHYL
Humanwell Puracap
December 7, 2023ANDA216811 Icosapent ethyl
ICOSAPENT ETHYL
Ascent Pharms Inc
December 5, 2023ANDA212629 Prednisone
PREDNISONE
Pharmazone
November 28, 2023ANDA206288 Darunavir
DARUNAVIR
Cipla
November 28, 2023ANDA215389 Darunavir
DARUNAVIR
Msn
November 20, 2023ANDA217020 Probenecid
PROBENECID
Rising
November 14, 2023ANDA216524 Estradiol
ESTRADIOL
Padagis Israel
November 2, 2023ANDA215365 Fluphenazine decanoate
FLUPHENAZINE DECANOATE
Msn
October 30, 2023ANDA209389 Ondansetron
ONDANSETRON
Ipca Labs Ltd
October 18, 2023ANDA217427 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Granules
October 11, 2023ANDA217738 Naproxen and esomeprazole magnesium
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
Sciegen Pharms
October 5, 2023ANDA217631 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Laurus
October 3, 2023ANDA214874 Glipizide
GLIPIZIDE
Rubicon Research
September 26, 2023ANDA215527 Divalproex sodium
DIVALPROEX SODIUM
Annora Pharma
September 12, 2023ANDA214344 Atorvastatin
ATORVASTATIN CALCIUM
Hetero Labs Ltd V
September 7, 2023ANDA217732 Fenofibrate
FENOFIBRATE
Creekwood Pharms
September 6, 2023ANDA217334 Estradiol
ESTRADIOL
Novitium Pharma
September 5, 2023ANDA218122 Loperamide hydrochloride
LOPERAMIDE HYDROCHLORIDE
Aurobindo Pharma Ltd
August 28, 2023ANDA216488 Posaconazole
POSACONAZOLE
Pharmazone
August 25, 2023ANDA214547 Lisdexamfetamine dimesylate
LISDEXAMFETAMINE DIMESYLATE
Norwich
August 25, 2023ANDA215330 Lisdexamfetamine dimesylate
LISDEXAMFETAMINE DIMESYLATE
Rhodes Pharms
August 23, 2023ANDA217695 Dexamethasone
DEXAMETHASONE
Apotex
August 22, 2023ANDA215609 Tretinoin
TRETINOIN MICROSPHERE
Encube
August 17, 2023ANDA217652 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Graviti Pharms
August 7, 2023ANDA217269 Guanfacine
GUANFACINE HYDROCHLORIDE
Alembic
August 4, 2023ANDA217916 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Bionpharma
August 3, 2023ANDA217748 Allopurinol
ALLOPURINOL
Hetero Labs Ltd V
July 28, 2023ANDA211718 Loratadine
LORATADINE
Hetero Labs Ltd V
July 28, 2023ANDA211914 Brinzolamide
BRINZOLAMIDE
Padagis Us
July 24, 2023ANDA211901 Plerixafor
PLERIXAFOR
Msn
July 19, 2023ANDA217995 Gabapentin
GABAPENTIN
Rising
July 17, 2023ANDA214649 Hydrocortisone
HYDROCORTISONE
Aurobindo Pharma Ltd
July 11, 2023ANDA217357 Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Mankind Pharma
July 10, 2023ANDA215972 Ramelteon
RAMELTEON
Aurobindo Pharma Ltd
July 7, 2023ANDA217137 Famotidine
FAMOTIDINE
Carnegie
June 15, 2023ANDA216364 Sodium bicarbonate
SODIUM BICARBONATE
Omnivium Pharms
June 12, 2023ANDA216916 Metoprolol
METOPROLOL SUCCINATE
Granules
June 2, 2023ANDA211763 Nadolol
NADOLOL
Alembic
June 1, 2023ANDA204801 Olmesartan medoxomil and hydrochlorothiazide
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Macleods Pharms
May 31, 2023ANDA216800 Bupropion
BUPROPION HYDROCHLORIDE
Annora Pharma
May 30, 2023ANDA216941 Mesalamine
MESALAMINE
Encube
May 26, 2023ANDA206883 Sevelamer hydrochloride
SEVELAMER HYDROCHLORIDE
Macleods Pharms
May 19, 2023ANDA217411 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE
Rising
May 18, 2023ANDA217390 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Granules
May 12, 2023ANDA217337 Mesalamine
MESALAMINE
Sinotherapeutics Inc
May 11, 2023ANDA216548 Diclofenac
DICLOFENAC SODIUM
Rubicon Research
May 3, 2023ANDA215705 Sucralfate
SUCRALFATE
Zydus Lifesciences
April 25, 2023ANDA213079 Tazarotene
TAZAROTENE
Padagis Israel
April 19, 2023ANDA206100 Sevelamer carbonate
SEVELAMER CARBONATE
Macleods Pharms
April 19, 2023ANDA217001 Dexamethasone
DEXAMETHASONE
Bionpharma
April 18, 2023ANDA215056 Cevimeline hydrochloride
CEVIMELINE HYDROCHLORIDE
Aurobindo Pharma
April 6, 2023ANDA216682 Cevimeline hydrochloride
CEVIMELINE HYDROCHLORIDE
Rubicon Research
April 4, 2023ANDA217478 Prochlorperazine
PROCHLORPERAZINE MALEATE
Bionpharma
March 30, 2023ANDA209225 Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Aurobindo Pharma
March 22, 2023ANDA207209 Repaglinide
REPAGLINIDE
Macleods Pharms
March 21, 2023ANDA217272 Nitrofurantoin
NITROFURANTOIN
Mankind Pharma
March 10, 2023ANDA216957 Clindamycin
CLINDAMYCIN HYDROCHLORIDE
Glenmark Pharms Ltd
February 23, 2023ANDA216759 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Bionpharma
February 9, 2023ANDA215243 Ramelteon
RAMELTEON
Micro Labs
January 26, 2023ANDA216876 Loperamide hydrochloride
LOPERAMIDE HYDROCHLORIDE
Rubicon Research
January 25, 2023ANDA201962 Varenicline tartrate
VARENICLINE TARTRATE
Apotex
January 19, 2023ANDA216728 Sirolimus
SIROLIMUS
Msn
January 18, 2023ANDA217399 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL
Msn
December 30, 2022ANDA215697 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE
Mankind Pharma
December 27, 2022ANDA217054 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Twi Pharms
December 21, 2022ANDA211417 Levothyroxine
LEVOTHYROXINE SODIUM
Macleods Pharms
December 14, 2022ANDA216736 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Rubicon Research
December 9, 2022ANDA214582 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Quagen
December 2, 2022ANDA206720 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL
Prinston Inc
November 28, 2022ANDA214849 Ursodiol
URSODIOL
Aurobindo Pharma Ltd
November 28, 2022ANDA216537 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA
Aurobindo Pharma Ltd
November 21, 2022ANDA216212 Erythromycin ethylsuccinate
ERYTHROMYCIN ETHYLSUCCINATE
Cadila Pharms Ltd
November 15, 2022ANDA215980 Levetiracetam
LEVETIRACETAM
Msn
October 21, 2022ANDA217038 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Zydus Lifesciences
October 17, 2022ANDA216629 Furosemide
FUROSEMIDE
Graviti Pharms
October 6, 2022ANDA213699 Naproxen and esomeprazole magnesium
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
Ajanta Pharma Ltd
September 29, 2022ANDA208098 Diclofenac
DICLOFENAC SODIUM
Sun Pharma Canada
September 28, 2022ANDA209485 Mirabegron
MIRABEGRON
Lupin
September 27, 2022ANDA216798 Fenofibrate
FENOFIBRATE
Aurobindo Pharma
September 23, 2022ANDA216275 Diclofenac
DICLOFENAC SODIUM
Ingenus Pharms LLC
September 23, 2022ANDA216521 Diltiazem
DILTIAZEM HYDROCHLORIDE
Sciegen Pharms
September 21, 2022ANDA216505 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA
Rubicon Research
September 16, 2022ANDA202666 Dexlansoprazole
DEXLANSOPRAZOLE
Twi Pharms
September 8, 2022ANDA215599 Flecainide acetate
FLECAINIDE ACETATE
Yichang Humanwell
August 26, 2022ANDA215315 Mexiletine hydrochloride
MEXILETINE HYDROCHLORIDE
Rising
August 24, 2022ANDA215435 Ramelteon
RAMELTEON
Andas 5 Holding
August 18, 2022ANDA216594 Carbamazepine
CARBAMAZEPINE
Umedica
August 15, 2022ANDA215478 Quetiapine
QUETIAPINE FUMARATE
Unichem
August 11, 2022ANDA210609 Tadalafil
TADALAFIL
Prinston Inc
August 8, 2022ANDA215604 Dexamethasone
DEXAMETHASONE
Novitium Pharma
August 4, 2022ANDA215364 Bumetanide
BUMETANIDE
Msn
August 4, 2022ANDA215587 Chlorthalidone
CHLORTHALIDONE
Mankind Pharma
July 26, 2022ANDA210859 Ezetimibe
EZETIMIBE
Hetero Labs Ltd III
July 19, 2022ANDA215835 Chlordiazepoxide hydrochloride and clidinium bromide
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Micro Labs
July 15, 2022ANDA214757 Levetiracetam
LEVETIRACETAM
Msn
July 7, 2022ANDA213273 Enalapril maleate
ENALAPRIL MALEATE
Prinston Inc
June 24, 2022ANDA215113 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE
Msn
June 3, 2022ANDA216441 Famotidine
FAMOTIDINE
Zydus Pharms
May 31, 2022ANDA212464 Adapalene and benzoyl peroxide
ADAPALENE AND BENZOYL PEROXIDE
Padagis Israel
May 31, 2022ANDA215279 Fludrocortisone acetate
FLUDROCORTISONE ACETATE
Novitium Pharma
May 20, 2022ANDA212708 Pirfenidone
PIRFENIDONE
Alembic
May 11, 2022ANDA215750 Diclofenac
DICLOFENAC POTASSIUM
Umedica
May 10, 2022ANDA207588 Levothyroxine
LEVOTHYROXINE SODIUM
Watson Labs Teva
April 27, 2022ANDA213517 Ranolazine
RANOLAZINE
Pharmazone
April 12, 2022ANDA215847 Betamethasone dipropionate
BETAMETHASONE DIPROPIONATE
Padagis Israel
April 7, 2022ANDA212682 Nebivolol
NEBIVOLOL HYDROCHLORIDE
Prinston Inc
April 5, 2022ANDA213126 Chlorzoxazone
CHLORZOXAZONE
Rising
March 28, 2022ANDA215672 Prednisone
PREDNISONE
Aurobindo Pharma Ltd
March 24, 2022ANDA214404 Clobazam
CLOBAZAM
Aurobindo Pharma Ltd
March 23, 2022ANDA215788 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Pharmazone
March 7, 2022ANDA214443 Allopurinol
ALLOPURINOL
Harman Finochem
February 24, 2022ANDA212875 Chlorthalidone
CHLORTHALIDONE
Pharmobedient
February 24, 2022ANDA212878 Chlorthalidone
CHLORTHALIDONE
Pharmobedient
February 23, 2022ANDA216211 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Rubicon Research
February 11, 2022ANDA212715 Tobramycin and dexamethasone
TOBRAMYCIN AND DEXAMETHASONE
Padagis Us
February 9, 2022ANDA211320 Chlorthalidone
CHLORTHALIDONE
Adaptis
February 9, 2022ANDA215710 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE
Mankind Pharma
February 2, 2022ANDA215568 Bupropion
BUPROPION HYDROCHLORIDE
Granules
January 26, 2022ANDA215995 Bisoprolol fumarate and hydrochlorothiazide
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Glenmark Pharms Ltd
January 25, 2022ANDA215936 Dorzolamide hydrochloride and timolol maleate
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Micro Labs
January 11, 2022ANDA215939 Oxcarbazepine
OXCARBAZEPINE
Annora Pharma
January 7, 2022ANDA215630 Famotidine
FAMOTIDINE
Vkt Pharma
January 3, 2022ANDA213230 Silodosin
SILODOSIN
Pharmazone
December 17, 2021ANDA208717 Nebivolol
NEBIVOLOL HYDROCHLORIDE
Cadila Pharms Ltd
December 17, 2021ANDA211053 Nebivolol
NEBIVOLOL HYDROCHLORIDE
Aurobindo Pharma Ltd
December 3, 2021ANDA213320 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Harman Finochem
November 23, 2021ANDA211290 Isosorbide dinitrate
ISOSORBIDE DINITRATE
Ph Health
November 16, 2021ANDA215671 Prednisone
PREDNISONE
Aurobindo Pharma Ltd
November 9, 2021ANDA212984 Testosterone
TESTOSTERONE
Encube
November 4, 2021ANDA211047 Hydrocortisone valerate
HYDROCORTISONE VALERATE
Encube Ethicals
November 4, 2021ANDA215767 Famotidine
FAMOTIDINE
Annora Pharma
October 29, 2021ANDA215563 Bisoprolol fumarate
BISOPROLOL FUMARATE
Novitium Pharma
October 25, 2021ANDA207842 Eplerenone
EPLERENONE
Everest Lifesciences
October 22, 2021ANDA215579 Loperamide hydrochloride
LOPERAMIDE HYDROCHLORIDE
Bionpharma
October 20, 2021ANDA211789 Carisoprodol
CARISOPRODOL
Pharmazone
October 19, 2021ANDA211799 Cholestyramine
CHOLESTYRAMINE LIGHT
Alkem Labs Ltd
October 19, 2021ANDA211856 Cholestyramine
CHOLESTYRAMINE
Alkem Labs Ltd
October 8, 2021ANDA215585 Diclofenac
DICLOFENAC POTASSIUM
Ingenus Pharms LLC
October 6, 2021ANDA215001 Loperamide hydrochloride
LOPERAMIDE HYDROCHLORIDE
Edenbridge Pharms
October 5, 2021ANDA214091 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA
Sciegen Pharms
October 1, 2021ANDA214089 Mexiletine hydrochloride
MEXILETINE HYDROCHLORIDE
Pharmazone
October 1, 2021ANDA214957 Gabapentin
GABAPENTIN
Ascent Pharms Inc
September 30, 2021ANDA212469 Zolmitriptan
ZOLMITRIPTAN
Padagis Israel
September 23, 2021ANDA209158 Brimonidine tartrate
BRIMONIDINE TARTRATE
Padagis Israel
August 19, 2021ANDA215101 Acetazolamide
ACETAZOLAMIDE
Rubicon Research
August 18, 2021ANDA211953 Labetalol
LABETALOL HYDROCHLORIDE
Rubicon Research
August 13, 2021ANDA208993 Colchicine
COLCHICINE
Hetero Labs Ltd V
August 11, 2021ANDA209929 Aspirin and extended-release dipyridamole
ASPIRIN AND DIPYRIDAMOLE
Micro Labs
August 10, 2021ANDA213566 Nystatin
NYSTATIN
Macleods Pharms
August 9, 2021ANDA204438 Glycopyrrolate
GLYCOPYRROLATE
Ph Health
August 6, 2021ANDA214654 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Yichang Humanwell
August 3, 2021ANDA211890 Ibuprofen and famotidine
IBUPROFEN AND FAMOTIDINE
Alkem Labs Ltd
July 27, 2021ANDA212482 Lidocaine and prilocaine
LIDOCAINE AND PRILOCAINE
Padagis Us
July 19, 2021ANDA213361 Nifedipine
NIFEDIPINE
Aurobindo Pharma
July 15, 2021ANDA204355 Diclofenac sodium and misoprostol
DICLOFENAC SODIUM AND MISOPROSTOL
Micro Labs
July 14, 2021ANDA214659 Atorvastatin
ATORVASTATIN CALCIUM
DR Reddys
July 13, 2021ANDA214099 Baclofen
BACLOFEN
Aurobindo Pharma Ltd
July 12, 2021ANDA213890 Promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE
Quagen
June 22, 2021ANDA091141 Formoterol fumarate
FORMOTEROL FUMARATE
Teva Pharms USA Inc
May 19, 2021ANDA214548 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE
Unichem
May 10, 2021ANDA214956 Gabapentin
GABAPENTIN
Ascent Pharms Inc
April 30, 2021ANDA212623 Methocarbamol
METHOCARBAMOL
Pharmazone
April 28, 2021ANDA212433 Clindamycin phosphate and benzoyl peroxide
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Encube
April 26, 2021ANDA214065 Chlordiazepoxide hydrochloride and clidinium bromide
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Alkem Labs Ltd
April 21, 2021ANDA215076 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE
Alembic
April 20, 2021ANDA212695 Lidocaine
LIDOCAINE
Quagen
April 2, 2021ANDA212760 Fluocinolone acetonide
FLUOCINOLONE ACETONIDE
Quagen
April 2, 2021ANDA212761 Fluocinolone acetonide
FLUOCINOLONE ACETONIDE
Quagen
April 2, 2021ANDA212762 Fluocinolone acetonide
FLUOCINOLONE ACETONIDE
Quagen
March 30, 2021ANDA213827 Metolazone
METOLAZONE
Innogenix
March 29, 2021ANDA213652 Leflunomide
LEFLUNOMIDE
Aurobindo Pharma
March 19, 2021ANDA203767 Travoprost ophthalmic solution
TRAVOPROST
Micro Labs
March 19, 2021ANDA213486 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Graviti Pharms
March 8, 2021ANDA214604 Clindamycin
CLINDAMYCIN PHOSPHATE
Padagis Israel
March 5, 2021ANDA214374 Baclofen
BACLOFEN
Rising
February 26, 2021ANDA210559 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Indchemie Health
February 25, 2021ANDA213950 Norelgestromin and ethinyl estradiol
ETHINYL ESTRADIOL AND NORELGESTROMIN
Amneal
February 24, 2021ANDA212491 Cyproheptadine
CYPROHEPTADINE HYDROCHLORIDE, CYPROLARA
Quagen
February 19, 2021ANDA210220 Cefdinir
CEFDINIR
Alkem Labs Ltd
February 19, 2021ANDA213999 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE
Mankind Pharma
February 18, 2021ANDA079021 Atomoxetine
ATOMOXETINE HYDROCHLORIDE
Strides Pharma
February 18, 2021ANDA208111 Azelastine hydrochloride and fluticasone propionate
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
Padagis Israel
February 12, 2021ANDA213854 Metoprolol
METOPROLOL SUCCINATE
Yichang Humanwell
February 11, 2021ANDA208412 Prednisone
PREDNISONE
Strides Pharma
February 5, 2021ANDA212460 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Padagis Israel
February 5, 2021ANDA214420 Potassium citrate
POTASSIUM CITRATE
Ascent Pharms Inc
January 26, 2021ANDA214140 Aminocaproic acid
AMINOCAPROIC ACID
Carnegie
January 26, 2021ANDA214492 Zonisamide
ZONISAMIDE
Unichem
January 22, 2021ANDA213435 Albendazole
ALBENDAZOLE
Msn
January 22, 2021ANDA214803 Liothyronine sodium
LIOTHYRONINE SODIUM
Zydus Lifesciences
January 13, 2021ANDA214603 Gemfibrozil
GEMFIBROZIL
Ascent Pharms Inc
December 31, 2020ANDA212104 Clindamycin
CLINDAMYCIN PHOSPHATE
Padagis Israel
December 29, 2020ANDA214422 Potassium chloride
POTASSIUM CHLORIDE
Ascent Pharms Inc
December 16, 2020ANDA210704 Etodolac
ETODOLAC
Pharmaco
December 3, 2020ANDA205129 Celecoxib
CELECOXIB
Sciegen Pharms
December 3, 2020ANDA212451 Morphine sulfate
MORPHINE SULFATE
Alkem Labs Ltd
November 25, 2020ANDA211143 Metoprolol
METOPROLOL SUCCINATE
Alkem Labs Ltd
November 18, 2020ANDA213859 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Guangzhou Novaken
November 3, 2020ANDA203825 Nebivolol
NEBIVOLOL HYDROCHLORIDE
Hetero Labs Ltd III
November 2, 2020ANDA212093 Methadone hydrochloride
METHADONE HYDROCHLORIDE
Lannett Co Inc
October 26, 2020ANDA213815 Ramelteon
RAMELTEON
Appco
October 21, 2020ANDA214452 Potassium chloride
POTASSIUM CHLORIDE
Granules
October 20, 2020ANDA214219 Triazolam
TRIAZOLAM
Ingenus Pharms LLC
October 19, 2020ANDA212399 Levothyroxine
LEVOTHYROXINE SODIUM
Accord Hlthcare
October 9, 2020ANDA212378 Baclofen
BACLOFEN
Andas 5 Holding
October 7, 2020ANDA214282 Acetazolamide
ACETAZOLAMIDE
Mankind Pharma
October 6, 2020ANDA213560 Halobetasol propionate
HALOBETASOL PROPIONATE
Quagen
October 1, 2020ANDA207849 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE
Xiromed
September 21, 2020ANDA213465 Sumatriptan
SUMATRIPTAN
Padagis Israel
September 21, 2020ANDA213650 Sumatriptan
SUMATRIPTAN
Perrigo Uk Finco
September 16, 2020ANDA210683 Flecainide acetate
FLECAINIDE ACETATE
Regcon Holdings
September 10, 2020ANDA212475 Zafirlukast
ZAFIRLUKAST
Annora Pharma
September 9, 2020ANDA213614 Alosetron hydrochloride
ALOSETRON HYDROCHLORIDE
Mankind Pharma
August 28, 2020ANDA212982 Clobetasol propionate
CLOBETASOL PROPIONATE
Encube
August 24, 2020ANDA206463 Lidocaine
LIDOCAINE
Amneal
August 24, 2020ANDA213434 Paclitaxel
PACLITAXEL
Msn
August 21, 2020ANDA213186 Ramelteon
RAMELTEON
Granules
August 19, 2020ANDA213853 Atorvastatin
ATORVASTATIN CALCIUM
Umedica
August 18, 2020ANDA211324 Raloxifene hydrochloride
RALOXIFENE HYDROCHLORIDE
Cadila Pharms Ltd
August 17, 2020ANDA213603 Gabapentin
GABAPENTIN
Zhejiang Yongtai
August 14, 2020ANDA213358 Tamoxifen citrate
TAMOXIFEN CITRATE
Eugia Pharma
August 12, 2020ANDA213967 Methocarbamol
METHOCARBAMOL
Aurobindo Pharma Ltd
August 10, 2020ANDA212774 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE
Aurobindo Pharma Ltd
August 7, 2020ANDA209499 Icosapent ethyl
ICOSAPENT ETHYL
DR Reddys
August 4, 2020ANDA214031 Vardenafil
VARDENAFIL HYDROCHLORIDE
Alembic
July 28, 2020ANDA213474 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE
Aiping Pharm Inc
July 24, 2020ANDA202510 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE
Strides Pharma Intl
July 21, 2020ANDA213446 Amiodarone hydrochloride
AMIODARONE HYDROCHLORIDE
Unichem
July 17, 2020ANDA209069 Buprenorphine and naloxone
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Wes Pharma Inc
July 9, 2020ANDA212067 Baclofen
BACLOFEN
Unichem
July 9, 2020ANDA212678 Bisoprolol fumarate and hydrochlorothiazide
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Edenbridge Pharms
July 7, 2020ANDA211421 Chlordiazepoxide hydrochloride and clidinium bromide
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Nuvo Pharms Inc
July 6, 2020ANDA213324 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Unichem
July 1, 2020ANDA213479 Levorphanol tartrate
LEVORPHANOL TARTRATE
Novitium Pharma
July 1, 2020ANDA213559 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Quagen
June 15, 2020ANDA210093 OMEGA-3-ACID ethyl esters
OMEGA-3-ACID ETHYL ESTERS
Puracap Pharm LLC
June 12, 2020ANDA213864 Fenofibrate
FENOFIBRATE
Mankind Pharma
June 10, 2020ANDA213265 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Aurobindo Pharma Ltd
June 2, 2020ANDA211977 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Hetero Labs Ltd III
May 28, 2020ANDA204777 Dorzolamide hydrochloride and timolol maleate
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Micro Labs
May 27, 2020ANDA213798 Tizanidine
TIZANIDINE HYDROCHLORIDE
Rubicon Research
May 22, 2020ANDA212901 Amphetamine
AMPHETAMINE SULFATE
Pharmazone
May 21, 2020ANDA209457 Icosapent ethyl
ICOSAPENT ETHYL
Hikma
May 21, 2020ANDA212044 Amantadine
AMANTADINE HYDROCHLORIDE
Rubicon Research
May 18, 2020ANDA203083 Lansoprazole
LANSOPRAZOLE
Hetero Labs Ltd III
May 18, 2020ANDA208659 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL
Adaptis
May 8, 2020ANDA213794 Ibuprofen
IBUPROFEN
Aurobindo Pharma Ltd
April 16, 2020ANDA210835 Testosterone
TESTOSTERONE
Xiromed
April 15, 2020ANDA207798 Carbamazepine
CARBAMAZEPINE
Umedica
April 13, 2020ANDA210225 Ivermectin
IVERMECTIN
Padagis Israel
April 10, 2020ANDA212650 Ramelteon
RAMELTEON
Pharmazone
April 8, 2020ANDA213286 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Aurobindo Pharma Ltd
April 7, 2020ANDA212654 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE
Aiping Pharm Inc
March 30, 2020ANDA205601 Buprenorphine and naloxone
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Rhodes Pharms
March 18, 2020ANDA209553 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE
Yiling
March 18, 2020ANDA211122 Fenofibrate
FENOFIBRATE
Rising
March 11, 2020ANDA211861 Amphetamine
AMPHETAMINE SULFATE
Prinston Inc
February 21, 2020ANDA212517 Naproxen
NAPROXEN
Sciegen Pharms
February 20, 2020ANDA213413 Diphenoxylate hydrochloride and atropine sulfate
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Leading
February 19, 2020ANDA205143 Diclofenac sodium and misoprostol
DICLOFENAC SODIUM AND MISOPROSTOL
Yung Shin Pharm
February 18, 2020ANDA204206 Naproxen and esomeprazole magnesium
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
DR Reddys
February 11, 2020ANDA213412 Chlorthalidone
CHLORTHALIDONE
Alkem Labs Ltd
February 10, 2020ANDA208989 Fluocinonide
FLUOCINONIDE
Zydus Lifesciences
February 5, 2020ANDA204852 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE
Aurobindo Pharma
January 30, 2020ANDA210454 Methotrexate
METHOTREXATE SODIUM
Eugia Pharma
January 29, 2020ANDA201501 Acyclovir
ACYCLOVIR
Xiromed
January 24, 2020ANDA213343 Methotrexate
METHOTREXATE SODIUM
Accord Hlthcare
January 14, 2020ANDA212779 Potassium citrate
POTASSIUM CITRATE
Ani Pharms
January 6, 2020ANDA212026 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE
Amta
December 23, 2019ANDA210722 Loratadine
LORATADINE
Granules
December 17, 2019ANDA212083 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Lannett Co Inc
December 13, 2019ANDA212809 Captopril
CAPTOPRIL
Ajanta Pharma Ltd
November 27, 2019ANDA210628 Celecoxib
CELECOXIB
Pharmazone
November 26, 2019ANDA209063 Rivastigmine
RIVASTIGMINE
Breckenridge
November 26, 2019ANDA212976 Fluocinonide
FLUOCINONIDE
Xiromed
November 21, 2019ANDA213136 Atenolol
ATENOLOL
Unichem
November 20, 2019ANDA210198 Desonide
DESONIDE
Cadila
November 18, 2019ANDA205199 Amlodipine and atorvastatin
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Apotex
November 15, 2019ANDA211295 Clobetasol propionate
CLOBETASOL PROPIONATE
Encube
November 15, 2019ANDA211575 Prednisone
PREDNISONE
Novitium Pharma
November 14, 2019ANDA208701 Celecoxib
CELECOXIB
Cadila Pharms Ltd
November 14, 2019ANDA210907 Buspirone
BUSPIRONE HYDROCHLORIDE
Unichem
October 30, 2019ANDA212199 Naproxen
NAPROXEN SODIUM
Sciegen Pharms
October 18, 2019ANDA209286 Divalproex sodium
DIVALPROEX SODIUM
Lupin
October 9, 2019ANDA211343 Doxycycline
DOXYCYCLINE HYCLATE
Changzhou Pharm
October 8, 2019ANDA206912 Pregabalin
PREGABALIN
Hetero Labs Ltd III
October 7, 2019ANDA209366 Acyclovir
ACYCLOVIR
Adaptis
October 7, 2019ANDA209402 Doxycycline
DOXYCYCLINE HYCLATE
Changzhou Pharm
September 17, 2019ANDA208847 Olmesartan medoxomil and hydrochlorothiazide
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Pharmazone
September 13, 2019ANDA210019 Ivermectin
IVERMECTIN
Teva Pharms USA
September 13, 2019ANDA212624 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE
Ajanta Pharma Ltd
September 12, 2019ANDA212254 Chlorzoxazone
CHLORZOXAZONE
Novitium Pharma
September 9, 2019ANDA205397 Clindamycin phosphate and benzoyl peroxide
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Padagis Israel
September 6, 2019ANDA209876 Colchicine
COLCHICINE
DR Reddys
September 6, 2019ANDA210670 Fenofibrate
FENOFIBRATE
DR Reddys
September 6, 2019ANDA212197 Albuterol sulfate
ALBUTEROL SULFATE
Quagen
September 5, 2019ANDA209965 Fosaprepitant
FOSAPREPITANT DIMEGLUMINE
Msn
August 28, 2019ANDA212265 Decitabine
DECITABINE
Msn
August 27, 2019ANDA211232 Ethacrynic acid
ETHACRYNIC ACID
Sciegen Pharms
August 26, 2019ANDA211041 Nitisinone
NITISINONE
Novitium Pharma
August 19, 2019ANDA210188 Ranolazine
RANOLAZINE
Cadila
August 19, 2019ANDA211581 Triamterene
TRIAMTERENE
Tp Anda Holdings
August 19, 2019ANDA212543 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE
Rubicon Research
August 13, 2019ANDA210437 Rocuronium bromide
ROCURONIUM BROMIDE
Piramal Critical
August 7, 2019ANDA206455 OMEGA-3-ACID ethyl esters
OMEGA-3-ACID ETHYL ESTERS
Chartwell
August 6, 2019ANDA211627 Chlorthalidone
CHLORTHALIDONE
Unichem
August 1, 2019ANDA211712 Pindolol
PINDOLOL
Unichem
July 26, 2019ANDA212114 Emtricitabine and tenofovir disoproxil fumarate
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Laurus
July 25, 2019ANDA212281 Clotrimazole
CLOTRIMAZOLE
Tp Anda Holdings
July 24, 2019ANDA212557 Nystatin
NYSTATIN
Torrent
July 22, 2019ANDA211567 Ramelteon
RAMELTEON
Zydus Pharms
July 19, 2019ANDA207799 Pregabalin
PREGABALIN
Alkem Labs Ltd
July 19, 2019ANDA208677 Pregabalin
PREGABALIN
Sciegen Pharms
July 19, 2019ANDA210432 Pregabalin
PREGABALIN
Rising
July 8, 2019ANDA212277 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Annora Pharma
June 28, 2019ANDA208708 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Rubicon Research
June 27, 2019ANDA211610 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Adaptis
June 14, 2019ANDA208783 Diltiazem
DILTIAZEM HYDROCHLORIDE
Novast Labs
May 22, 2019ANDA206296 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Zydus Pharms
May 22, 2019ANDA212423 Cyproheptadine
CYPROHEPTADINE HYDROCHLORIDE
Quagen
May 20, 2019ANDA210224 Solifenacin succinate
SOLIFENACIN SUCCINATE
Alkem Labs Ltd
May 20, 2019ANDA211657 Solifenacin succinate
SOLIFENACIN SUCCINATE
Sciegen Pharms
May 17, 2019ANDA210570 Cinacalcet
CINACALCET HYDROCHLORIDE
Alkem Labs Ltd
May 6, 2019ANDA210316 Colesevelam hydrochloride
COLESEVELAM HYDROCHLORIDE
Alkem Labs Ltd
April 29, 2019ANDA204800 Felodipine
FELODIPINE
Yung Shin Pharm
April 29, 2019ANDA210729 Vancomycin
VANCOMYCIN HYDROCHLORIDE
Orient Pharma Co Ltd
April 24, 2019ANDA206368 Testosterone cypionate
TESTOSTERONE CYPIONATE
Wilshire Pharms Inc
April 24, 2019ANDA206381 Rosuvastatin
ROSUVASTATIN CALCIUM
Sciegen Pharms
April 24, 2019ANDA212308 Leflunomide
LEFLUNOMIDE
Zydus Lifesciences
April 19, 2019ANDA207448 Mesalamine
MESALAMINE
Rising
April 9, 2019ANDA207626 Rosuvastatin
ROSUVASTATIN CALCIUM
Umedica
April 8, 2019ANDA211767 Clomipramine hydrochloride
CLOMIPRAMINE HYDROCHLORIDE
Mankind Pharma
April 5, 2019ANDA203410 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Micro Labs Ltd India
April 2, 2019ANDA206803 Selegiline
SELEGILINE HYDROCHLORIDE
Rising
March 29, 2019ANDA207004 Rasagiline
RASAGILINE MESYLATE
Micro Labs
March 27, 2019ANDA212196 Tizanidine
TIZANIDINE HYDROCHLORIDE
Alkem Labs Ltd
March 26, 2019ANDA208934 Tadalafil
TADALAFIL
Sun Pharm
March 26, 2019ANDA209167 Tadalafil
TADALAFIL
Accord Hlthcare
March 26, 2019ANDA209250 Tadalafil
TADALAFIL
Unichem
March 26, 2019ANDA209654 Tadalafil
TADALAFIL
Ajanta Pharma Ltd
March 26, 2019ANDA210221 Cephalexin
CEPHALEXIN
Alkem Labs Ltd
March 22, 2019ANDA208180 Roflumilast
ROFLUMILAST
Micro Labs
March 12, 2019ANDA205536 Valsartan
VALSARTAN
Alkem Labs Ltd
March 12, 2019ANDA210267 Tizanidine
TIZANIDINE HYDROCHLORIDE
Ingenus Pharms LLC
March 12, 2019ANDA210614 Nifedipine
NIFEDIPINE
Novast Labs
March 12, 2019ANDA211820 Allopurinol
ALLOPURINOL
Unichem
March 11, 2019ANDA210158 Dalfampridine
DALFAMPRIDINE
Micro Labs
March 8, 2019ANDA211064 Folic acid
FOLIC ACID
Rising
March 6, 2019ANDA204991 Atorvastatin
ATORVASTATIN CALCIUM
Lupin
February 28, 2019ANDA211655 Oxybutynin
OXYBUTYNIN CHLORIDE
Ajanta Pharma Ltd
February 26, 2019ANDA210001 Azithromycin
AZITHROMYCIN
Bionpharma
February 25, 2019ANDA207420 OMEGA-3-ACID ethyl esters
OMEGA-3-ACID ETHYL ESTERS
Ascent Pharms Inc
February 22, 2019ANDA211518 Benzonatate
BENZONATATE
Ascent Pharms Inc
February 21, 2019ANDA207105 Aripiprazole
ARIPIPRAZOLE
Alkem Labs Ltd
February 21, 2019ANDA211031 Exemestane
EXEMESTANE
Breckenridge
February 13, 2019ANDA209913 Fluocinolone acetonide
FLUOCINOLONE ACETONIDE
Encube Ethicals
February 11, 2019ANDA208358 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Cadila
February 8, 2019ANDA211250 Colchicine
COLCHICINE
Alkem Labs Ltd
February 8, 2019ANDA211933 Atorvastatin
ATORVASTATIN CALCIUM
Msn
February 5, 2019ANDA211293 Estradiol
ESTRADIOL
Amneal
February 4, 2019ANDA208702 Acyclovir
ACYCLOVIR
Padagis Israel
February 1, 2019ANDA208737 Methylphenidate
METHYLPHENIDATE HYDROCHLORIDE
Cediprof Inc
February 1, 2019ANDA211555 Baclofen
BACLOFEN
Adaptis
January 30, 2019ANDA208891 Fluticasone propionate and salmeterol
WIXELA INHUB
Mylan
January 30, 2019ANDA210998 Desonide
DESONIDE
Encube Ethicals
January 28, 2019ANDA211020 Bupropion
BUPROPION HYDROCHLORIDE
Graviti Pharms
January 22, 2019ANDA205401 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Ani Pharms
January 18, 2019ANDA209713 Levothyroxine
LEVOTHYROXINE SODIUM
Lupin
January 15, 2019ANDA210708 Eletriptan hydrobromide
ELETRIPTAN HYDROBROMIDE
Aurobindo Pharma
January 14, 2019ANDA203561 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Sciegen Pharms
January 4, 2019ANDA203379 Glyburide
GLYBURIDE
Cadila Pharms Ltd
December 21, 2018ANDA209288 Atorvastatin
ATORVASTATIN CALCIUM
Alkem Labs Ltd
December 19, 2018ANDA206948 Benzonatate
BENZONATATE
Puracap Pharm LLC
December 19, 2018ANDA210921 Potassium chloride
POTASSIUM CHLORIDE
Aurobindo Pharma
December 13, 2018ANDA211484 Levorphanol tartrate
LEVORPHANOL TARTRATE
Acertis Pharms
December 7, 2018ANDA204276 Ergocalciferol
ERGOCALCIFEROL
Puracap Pharm LLC
December 4, 2018ANDA210302 Candesartan cilexetil
CANDESARTAN CILEXETIL
Alembic
December 3, 2018ANDA211166 Silodosin
SILODOSIN
Macleods Pharms
November 29, 2018ANDA209699 Fluocinonide
FLUOCINONIDE
Encube Ethicals
November 23, 2018ANDA210200 Potassium chloride
POTASSIUM CHLORIDE
Epic Pharma LLC
November 23, 2018ANDA211542 Temazepam
TEMAZEPAM
Alembic
November 23, 2018ANDA211659 Baclofen
BACLOFEN
Zydus Lifesciences
November 19, 2018ANDA208724 Azelaic acid
AZELAIC ACID
Encube
November 14, 2018ANDA205869 Letrozole
LETROZOLE
Pharmobedient
November 7, 2018ANDA210662 Tetracycline hydrochloride
TETRACYCLINE HYDROCHLORIDE
Breckenridge
November 7, 2018ANDA211487 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Ascent Pharms Inc
November 5, 2018ANDA207402 Clindamycin
CLINDAMYCIN HYDROCHLORIDE
Micro Labs
November 5, 2018ANDA210918 Isosorbide mononitrate
ISOSORBIDE MONONITRATE
Riconpharma LLC
November 2, 2018ANDA207613 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE
Unique
October 31, 2018ANDA208446 Abiraterone acetate
ABIRATERONE ACETATE
Mylan
October 31, 2018ANDA209057 Vardenafil
VARDENAFIL HYDROCHLORIDE
Crossmedika SA
October 31, 2018ANDA209587 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Lgm Pharma
October 31, 2018ANDA210497 Bupropion
BUPROPION HYDROCHLORIDE
Accord Hlthcare
October 29, 2018ANDA207169 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE
Ph Health
October 29, 2018ANDA207509 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Adaptis
October 26, 2018ANDA207465 Metoprolol
METOPROLOL SUCCINATE
Cipla
October 26, 2018ANDA211285 Progesterone
PROGESTERONE
Eugia Pharma
October 25, 2018ANDA208249 Azithromycin
AZITHROMYCIN
Cspc Ouyi
October 23, 2018ANDA209973 Desoximetasone
DESOXIMETASONE
The J Molner
October 18, 2018ANDA207659 Acetazolamide
ACETAZOLAMIDE
Accord Hlthcare
October 16, 2018ANDA211314 Gabapentin
GABAPENTIN
Strides Pharma
October 16, 2018ANDA211347 Bupropion
BUPROPION HYDROCHLORIDE
Yichang Humanwell
October 12, 2018ANDA206401 Sildenafil
SILDENAFIL CITRATE
Ajanta Pharma Ltd
October 5, 2018ANDA209038 Colesevelam hydrochloride
COLESEVELAM HYDROCHLORIDE
Alkem Labs Ltd
October 3, 2018ANDA210139 Methylphenidate
METHYLPHENIDATE HYDROCHLORIDE
Adaptis
October 3, 2018ANDA210971 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE
Novitium Pharma
October 1, 2018ANDA210014 Desvenlafaxine
DESVENLAFAXINE SUCCINATE
Yichang Humanwell
September 26, 2018ANDA211106 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Abhai LLC
September 19, 2018ANDA209211 Dexmethylphenidate hydrochloride
DEXMETHYLPHENIDATE HYDROCHLORIDE
Cediprof Inc
September 17, 2018ANDA204587 Ritonavir
RITONAVIR
Hetero Labs Ltd III
September 17, 2018ANDA206614 Ritonavir
RITONAVIR
Aurobindo Pharma Ltd
September 4, 2018ANDA203041 Efavirenz, emtricitabine and tenofovir disoproxil fumarate
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
Aurobindo Pharma
August 31, 2018ANDA210733 Potassium chloride
POTASSIUM CHLORIDE
Strides Pharma
August 30, 2018ANDA205231 Diltiazem
DILTIAZEM HYDROCHLORIDE
Twi Pharms
August 29, 2018ANDA090679 Lamivudine and zidovudine
LAMIVUDINE AND ZIDOVUDINE
Macleods Pharms
August 27, 2018ANDA209882 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Laurus
August 16, 2018ANDA090589 Epinephrine
EPINEPHRINE (AUTOINJECTOR)
Teva Pharms USA
July 27, 2018ANDA210893 Diclofenac
DICLOFENAC SODIUM
Padagis Israel
July 25, 2018ANDA205430 Guanfacine
GUANFACINE HYDROCHLORIDE
Apotex
July 23, 2018ANDA210955 Nadolol
NADOLOL
Regcon Holdings
July 20, 2018ANDA210138 Fenofibrate
FENOFIBRATE
Ajanta Pharma Ltd
July 5, 2018ANDA207370 Azithromycin
AZITHROMYCIN
Aurobindo Pharma Ltd
July 5, 2018ANDA207398 Azithromycin
AZITHROMYCIN
Aurobindo Pharma Ltd
June 29, 2018ANDA207046 Albuterol sulfate
ALBUTEROL SULFATE
Rising
June 29, 2018ANDA208130 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL
Sciegen Pharms
June 27, 2018ANDA202023 Sildenafil
SILDENAFIL CITRATE
Amneal Pharms Ny
June 22, 2018ANDA208921 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE
Pharmobedient
June 20, 2018ANDA209603 Labetalol
LABETALOL HYDROCHLORIDE
Appco
June 18, 2018ANDA209912 Atorvastatin
ATORVASTATIN CALCIUM
Graviti Pharms
June 15, 2018ANDA210034 Clobetasol propionate
CLOBETASOL PROPIONATE
Xiromed
June 14, 2018ANDA210015 Bupropion
BUPROPION HYDROCHLORIDE
Yichang Humanwell
June 11, 2018ANDA091448 Sildenafil
SILDENAFIL CITRATE
Torrent
June 11, 2018ANDA202659 Sildenafil
SILDENAFIL CITRATE
Hetero Labs Ltd V
June 7, 2018ANDA208834 Etodolac
ETODOLAC
Amneal Pharms Co
May 31, 2018ANDA207774 Doxycycline
DOXYCYCLINE HYCLATE
Zydus Lifesciences
May 25, 2018ANDA207767 Nystatin
NYSTATIN
Zydus Lifesciences
May 24, 2018ANDA207222 Chlorthalidone
CHLORTHALIDONE
Umedica
May 24, 2018ANDA208516 Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Sunny
May 23, 2018ANDA206164 Adapalene and benzoyl peroxide
ADAPALENE AND BENZOYL PEROXIDE
Encube
May 15, 2018ANDA210577 Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE
Amneal Pharms Co
May 14, 2018ANDA206943 Gabapentin
GABAPENTIN
Strides Pharma
May 7, 2018ANDA209312 Methocarbamol
METHOCARBAMOL
Granules
May 4, 2018ANDA210394 Sildenafil
SILDENAFIL CITRATE
Ajanta Pharma Ltd
May 3, 2018ANDA209696 Buspirone
BUSPIRONE HYDROCHLORIDE
Adaptis
May 1, 2018ANDA210441 Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE
Appco
April 30, 2018ANDA202900 Bumetanide
BUMETANIDE
Zydus Pharms
April 30, 2018ANDA204776 Celecoxib
CELECOXIB
Micro Labs
April 24, 2018ANDA208644 Rabeprazole sodium
RABEPRAZOLE SODIUM
Alkem Labs Ltd
April 23, 2018ANDA209283 Fluocinonide
FLUOCINONIDE
Macleods Pharms
April 17, 2018ANDA209013 Doxazosin
DOXAZOSIN MESYLATE
Somerset Theraps LLC
April 13, 2018ANDA209869 Pravastatin sodium
PRAVASTATIN SODIUM
Biocon Pharma
April 11, 2018ANDA209172 Cyproheptadine
CYPROHEPTADINE HYDROCHLORIDE
Strides Pharma Intl
March 30, 2018ANDA207687 Atorvastatin
ATORVASTATIN CALCIUM
Accord Hlthcare
March 23, 2018ANDA203817 Mesalamine
MESALAMINE
Actavis Labs Fl
March 23, 2018ANDA203894 Metoprolol
METOPROLOL SUCCINATE
Zydus Pharms
March 21, 2018ANDA207510 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN
Wes Pharma Inc
March 16, 2018ANDA209313 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Granules
March 8, 2018ANDA208915 Cinacalcet
CINACALCET HYDROCHLORIDE
Cipla
March 7, 2018ANDA210401 Acyclovir
ACYCLOVIR
Pharmobedient
March 6, 2018ANDA206069 Armodafinil
ARMODAFINIL
Aurobindo Pharma Ltd
March 5, 2018ANDA209758 Potassium citrate
POTASSIUM CITRATE
Teva Pharms USA Inc
March 5, 2018ANDA209767 Estradiol
ESTRADIOL
Encube
March 2, 2018ANDA209498 Tenofovir disoproxil fumarate
TENOFOVIR DISOPROXIL FUMARATE
Qilu
February 23, 2018ANDA090609 Atomoxetine
ATOMOXETINE HYDROCHLORIDE
DR Reddys
February 12, 2018ANDA206921 Glatiramer acetate
GLATOPA
Sandoz
February 2, 2018ANDA210175 Oxymorphone hydrochloride
OXYMORPHONE HYDROCHLORIDE
Ascent Pharms Inc
January 26, 2018ANDA090636 Tenofovir disoproxil fumarate
TENOFOVIR DISOPROXIL FUMARATE
Hetero Labs Ltd III
January 26, 2018ANDA210347 Piroxicam
PIROXICAM
Strides Pharma
January 23, 2018ANDA205033 Adapalene and benzoyl peroxide
ADAPALENE AND BENZOYL PEROXIDE
Padagis Israel
January 23, 2018ANDA210071 Celecoxib
CELECOXIB
Cspc Ouyi
January 22, 2018ANDA210194 Estradiol
ESTRADIOL
Padagis Israel
January 12, 2018ANDA209688 Potassium chloride
POTASSIUM CHLORIDE
Twi Pharms
December 29, 2017ANDA206152 Piroxicam
PIROXICAM
Micro Labs
December 29, 2017ANDA210354 Methylphenidate
METHYLPHENIDATE HYDROCHLORIDE
Ascent Pharms Inc
December 28, 2017ANDA209799 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Nuvo Pharm
December 22, 2017ANDA203572 Lorazepam
LORAZEPAM
Aurobindo Pharma
December 22, 2017ANDA209335 Oxybutynin
OXYBUTYNIN CHLORIDE
Abhai LLC
December 21, 2017ANDA209025 Oxybutynin
OXYBUTYNIN CHLORIDE
Rising
December 21, 2017ANDA209234 Ezetimibe
EZETIMIBE
Alkem Labs Ltd
December 13, 2017ANDA207000 Buprenorphine and naloxone
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Specgx LLC
December 12, 2017ANDA205005 Nitrofurantoin
NITROFURANTOIN
Zydus Pharms
December 12, 2017ANDA209794 Metronidazole
METRONIDAZOLE
Cadila Pharms Ltd
December 6, 2017ANDA208518 Doxylamine succinate and pyridoxine hydrochloride
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Ph Health
November 29, 2017ANDA204253 Quetiapine
QUETIAPINE FUMARATE
Macleods Pharms
November 28, 2017ANDA209102 Baclofen
BACLOFEN
Rubicon Research
November 22, 2017ANDA208898 Rosuvastatin
ROSUVASTATIN CALCIUM
Msn
November 21, 2017ANDA209556 Hydrocortisone butyrate
HYDROCORTISONE BUTYRATE
The J Molner
November 20, 2017ANDA209757 Clonidine
CLONIDINE HYDROCHLORIDE
Xiamen LP Pharm Co
November 16, 2017ANDA205689 Guanfacine
GUANFACINE HYDROCHLORIDE
Sun Pharm
November 16, 2017ANDA209419 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Ph Health
November 6, 2017ANDA204901 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Prinston Inc
November 3, 2017ANDA202821 Flecainide acetate
FLECAINIDE ACETATE
Aurobindo Pharma Ltd
November 2, 2017ANDA207435 Amlodipine and olmesartan medoxomil
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Micro Labs
October 30, 2017ANDA207773 Doxycycline
DOXYCYCLINE HYCLATE
Zydus Lifesciences
October 30, 2017ANDA210211 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Wes Pharma Inc
October 26, 2017ANDA207057 Gabapentin
GABAPENTIN
Cspc Ouyi
October 25, 2017ANDA090132 Carvedilol
CARVEDILOL PHOSPHATE
Sun Pharm Industries
October 20, 2017ANDA205229 Progesterone
PROGESTERONE
Xiromed
October 18, 2017ANDA210059 Dextroamphetamine
DEXTROAMPHETAMINE SULFATE
Nuvo Pharm
October 16, 2017ANDA205888 Prasugrel
PRASUGREL
Aurobindo Pharma
October 13, 2017ANDA202670 Mitomycin
MITOMYCIN
Adaptis
October 10, 2017ANDA205253 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE
Zydus Pharms
September 28, 2017ANDA209582 Doxycycline
DOXYCYCLINE
Zydus Pharms
September 19, 2017ANDA207743 Labetalol
LABETALOL HYDROCHLORIDE
Zydus Pharms
September 18, 2017ANDA207389 Bupropion
BUPROPION HYDROCHLORIDE
Invagen Pharms
September 11, 2017ANDA206813 Potassium citrate
POTASSIUM CITRATE
Strides Pharma
September 8, 2017ANDA206923 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE
Accord Hlthcare
September 7, 2017ANDA200884 Fenofibrate
FENOFIBRATE
Sun Pharm
September 7, 2017ANDA207724 Progesterone
PROGESTERONE
Amneal Pharms Ny
September 6, 2017ANDA209215 Guaifenesin
GUAIFENESIN
Guardian Drug
September 1, 2017ANDA205563 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Lannett Co Inc
August 30, 2017ANDA205868 Lansoprazole
LANSOPRAZOLE
Adaptis
August 25, 2017ANDA209838 Ezetimibe
EZETIMIBE
Aurobindo Pharma
August 21, 2017ANDA209411 Clobetasol propionate
CLOBETASOL PROPIONATE (EMOLLIENT)
Beach Prods
August 16, 2017ANDA206261 Acyclovir
ACYCLOVIR
Carlsbad
August 16, 2017ANDA207196 Modafinil
MODAFINIL
Appco
August 14, 2017ANDA208479 Nystatin and triamcinolone acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Padagis Israel
August 11, 2017ANDA206641 Diltiazem
DILTIAZEM HYDROCHLORIDE
Zydus Pharms
August 11, 2017ANDA207405 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE
Alkem Labs Ltd
August 8, 2017ANDA206534 Diltiazem
DILTIAZEM HYDROCHLORIDE
Zydus Pharms
August 7, 2017ANDA207418 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE
Ascent Pharms Inc
July 31, 2017ANDA206200 Budesonide
BUDESONIDE
Amneal Pharms
July 28, 2017ANDA207761 Nadolol
NADOLOL
Zydus Pharms
July 25, 2017ANDA208605 Telmisartan
TELMISARTAN
Cadila Pharms Ltd
July 21, 2017ANDA204832 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Unichem
July 21, 2017ANDA206388 Estradiol
ESTRADIOL
Teva Pharms USA
July 21, 2017ANDA208507 Methocarbamol
METHOCARBAMOL
Regcon Holdings
July 13, 2017ANDA206922 Eplerenone
EPLERENONE
Accord Hlthcare
July 10, 2017ANDA090961 Memantine hydrochloride
MEMANTINE HYDROCHLORIDE
Zydus Lifesciences
July 7, 2017ANDA208719 Doxazosin
DOXAZOSIN MESYLATE
Zydus Pharms
June 30, 2017ANDA090080 Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE
Apotex
June 28, 2017ANDA207482 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE
Amneal Pharms Co
June 16, 2017ANDA206409 Eletriptan hydrobromide
ELETRIPTAN HYDROBROMIDE
Zydus Pharms
June 15, 2017ANDA203695 Metaxalone
METAXALONE
Actavis Labs Fl Inc
June 12, 2017ANDA200831 Ezetimibe
EZETIMIBE
Watson Labs Inc
June 12, 2017ANDA203931 Ezetimibe
EZETIMIBE
Sandoz
June 12, 2017ANDA208803 Ezetimibe
EZETIMIBE
Amneal Pharms Co
June 12, 2017ANDA209171 Amantadine
AMANTADINE HYDROCHLORIDE
Heritage Pharma
June 7, 2017ANDA209047 Amantadine
AMANTADINE HYDROCHLORIDE
Strides Pharma
June 1, 2017ANDA205798 Mirtazapine
MIRTAZAPINE
Square Pharms PLC
May 31, 2017ANDA208170 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Rubicon Research
May 30, 2017ANDA079016 Atomoxetine
ATOMOXETINE HYDROCHLORIDE
Aurobindo Pharma
May 30, 2017ANDA079019 Atomoxetine
ATOMOXETINE HYDROCHLORIDE
Glenmark Pharms Ltd
May 26, 2017ANDA205236 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE
Sciegen Pharms
May 25, 2017ANDA203281 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL
Glenmark Pharms Ltd
May 23, 2017ANDA204058 Lisinopril and hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Invagen Pharms
May 18, 2017ANDA206653 Duloxetine
DULOXETINE HYDROCHLORIDE
Prinston Inc
May 12, 2017ANDA206928 Glipizide
GLIPIZIDE
Aurobindo Pharma
May 11, 2017ANDA207237 Carisoprodol
CARISOPRODOL
Mpp Pharma
May 5, 2017ANDA206173 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Cadila Pharms Ltd
May 4, 2017ANDA208633 Oxaprozin
OXAPROZIN
Amneal Pharms Co
May 3, 2017ANDA207882 Telmisartan
TELMISARTAN
Prinston Inc
April 26, 2017ANDA207658 Temozolomide
TEMOZOLOMIDE
Deva Holding As
April 24, 2017ANDA204233 Olmesartan medoxomil and hydrochlorothiazide
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Alembic
April 24, 2017ANDA204798 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL
Aurobindo Pharma
April 24, 2017ANDA205391 Olmesartan medoxomil and hydrochlorothiazide
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Aurobindo Pharma
April 24, 2017ANDA206763 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL
Alkem Labs Ltd
April 24, 2017ANDA207662 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL
Accord Hlthcare
April 24, 2017ANDA207804 Olmesartan medoxomil and hydrochlorothiazide
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Prinston Inc
April 19, 2017ANDA202294 Dexlansoprazole
DEXLANSOPRAZOLE
Ph Health
April 13, 2017ANDA208340 Piroxicam
PIROXICAM
Unichem
April 12, 2017ANDA207479 Bupropion
BUPROPION HYDROCHLORIDE
Sciegen Pharms
April 5, 2017ANDA208698 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Alembic
March 27, 2017ANDA207276 Buprenorphine
BUPRENORPHINE HYDROCHLORIDE
Rhodes Pharms
March 22, 2017ANDA207152 Tramadol hydrochloride and acetaminophen
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Aurobindo Pharma
March 22, 2017ANDA207419 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN
Ascent Pharms Inc
March 21, 2017ANDA206465 Rosuvastatin
ROSUVASTATIN CALCIUM
Alkem Labs Ltd
March 17, 2017ANDA208864 Potassium chloride
POTASSIUM CHLORIDE
Adare Pharms Inc
March 10, 2017ANDA207810 Lidocaine
LIDOCAINE
Alkem Labs Ltd
February 28, 2017ANDA204022 Ropinirole
ROPINIROLE HYDROCHLORIDE
Accord Hlthcare
February 28, 2017ANDA204255 Testosterone
TESTOSTERONE
Padagis Israel
February 17, 2017ANDA204375 Ziprasidone
ZIPRASIDONE HYDROCHLORIDE
Macleods Pharms
February 17, 2017ANDA205761 Rabeprazole sodium
RABEPRAZOLE SODIUM
Quagen
February 16, 2017ANDA208963 Fluconazole
FLUCONAZOLE
Zydus Pharms
January 31, 2017ANDA202853 Olopatadine hydrochloride
OLOPATADINE HYDROCHLORIDE
Padagis Israel
January 31, 2017ANDA207741 Nystatin and triamcinolone acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE
DR Reddys
January 27, 2017NDA208799 Fluticasone propionate and salmeterol
AIRDUO DIGIHALER, AIRDUO RESPICLICK
Teva Pharm
January 24, 2017ANDA204170 Zolpidem tartrate
ZOLPIDEM TARTRATE
Sun Pharm
January 20, 2017ANDA204645 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE
Macleods Pharms
January 20, 2017ANDA206441 Desoximetasone
DESOXIMETASONE
Padagis Israel
January 6, 2017ANDA207750 Finasteride
FINASTERIDE
Alkem Labs Ltd
January 6, 2017ANDA208706 Duloxetine
DULOXETINE HYDROCHLORIDE
Ajanta Pharma Ltd
January 5, 2017ANDA204304 Finasteride
FINASTERIDE
Alkem Labs Ltd
January 3, 2017ANDA207201 Glycopyrrolate
GLYCOPYRROLATE
Appco
December 30, 2016ANDA204755 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Micro Labs Ltd India
December 30, 2016ANDA205707 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Micro Labs Ltd India
December 29, 2016ANDA204720 Glipizide
GLIPIZIDE
Unique
December 20, 2016ANDA207380 Nystatin and triamcinolone acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Padagis Israel
December 15, 2016ANDA208709 Fenofibrate
FENOFIBRATE
Cipla
December 5, 2016ANDA203813 Candesartan cilexetil
CANDESARTAN CILEXETIL
Macleods Pharms
November 30, 2016ANDA202842 Dexmethylphenidate hydrochloride
DEXMETHYLPHENIDATE HYDROCHLORIDE
Ph Health
November 29, 2016ANDA206553 Cyproheptadine
CYPROHEPTADINE HYDROCHLORIDE
Tp Anda Holdings
November 25, 2016ANDA203995 Diclofenac sodium and misoprostol
DICLOFENAC SODIUM AND MISOPROSTOL
Amneal Pharms
November 23, 2016ANDA202413 Ibuprofen
IBUPROFEN
Shandong Xinhua
November 23, 2016ANDA207511 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE
Adaptis
November 22, 2016ANDA204770 Metaxalone
METAXALONE
Lannett Co Inc
November 17, 2016ANDA205209 Darifenacin
DARIFENACIN HYDROBROMIDE
Torrent
November 17, 2016ANDA207068 Pravastatin sodium
PRAVASTATIN SODIUM
Accord Hlthcare
November 16, 2016ANDA206560 Metronidazole
METRONIDAZOLE
Cadila
October 31, 2016ANDA201619 Rosuvastatin
ROSUVASTATIN CALCIUM
Torrent
October 31, 2016ANDA206434 Rosuvastatin
ROSUVASTATIN CALCIUM
Accord Hlthcare
October 31, 2016ANDA207408 Rosuvastatin
ROSUVASTATIN CALCIUM
Changzhou Pharm
October 31, 2016ANDA207616 Rosuvastatin
ROSUVASTATIN CALCIUM
Hetero Labs Ltd V
October 31, 2016ANDA207752 Rosuvastatin
ROSUVASTATIN CALCIUM
Biocon Pharma
October 28, 2016ANDA207118 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Nuvo Pharms Inc
October 26, 2016ANDA206137 Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Ph Health
October 21, 2016ANDA206574 Dutasteride
DUTASTERIDE
Ascent Pharms Inc
October 21, 2016ANDA207428 Sotalol hydrochloride
SOTALOL HYDROCHLORIDE
Regcon Holdings
October 12, 2016ANDA206384 Raloxifene hydrochloride
RALOXIFENE HYDROCHLORIDE
Sciegen Pharms
September 28, 2016ANDA204453 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE
Alkem Labs Ltd
September 19, 2016ANDA203512 Spironolactone
SPIRONOLACTONE
Accord Hlthcare
September 19, 2016ANDA205022 Buprenorphine and naloxone
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Lannett Co Inc
September 15, 2016ANDA205823 Quinapril
QUINAPRIL HYDROCHLORIDE
Prinston Inc
September 15, 2016ANDA208451 Eszopiclone
ESZOPICLONE
Aurobindo Pharma
September 12, 2016ANDA206174 Aripiprazole
ARIPIPRAZOLE
Ajanta Pharma Ltd
September 2, 2016ANDA206116 Diclofenac
DICLOFENAC SODIUM
Amneal Pharms
August 30, 2016ANDA207133 Flurandrenolide
FLURANDRENOLIDE
Padagis Israel
August 29, 2016ANDA205670 Fosinopril sodium
FOSINOPRIL SODIUM
Prinston Inc
August 26, 2016ANDA207901 Dexmethylphenidate hydrochloride
DEXMETHYLPHENIDATE HYDROCHLORIDE
Tris Pharma Inc
August 19, 2016ANDA203836 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Ph Health
August 19, 2016ANDA206975 Bupropion
BUPROPION HYDROCHLORIDE
Heritage Pharma
July 28, 2016ANDA204467 Allopurinol
ALLOPURINOL
Regcon Holdings
July 26, 2016ANDA203562 Potassium chloride
POTASSIUM CHLORIDE
Glenmark Pharms Ltd
July 25, 2016ANDA203203 Lansoprazole
LANSOPRAZOLE
Xiromed
July 25, 2016ANDA203256 Tranexamic acid
TRANEXAMIC ACID
Ani Pharms
July 19, 2016ANDA079170 Rosuvastatin
ROSUVASTATIN CALCIUM
Aurobindo Pharma Ltd
July 12, 2016ANDA204598 Fenofibrate
FENOFIBRATE
Hetero Labs Ltd III
June 27, 2016ANDA207289 Doxycycline
DOXYCYCLINE HYCLATE
Amneal Pharms
June 17, 2016ANDA203266 Gemfibrozil
GEMFIBROZIL
Cadila Pharms Ltd
June 17, 2016ANDA204838 Aripiprazole
ARIPIPRAZOLE
Amneal Pharms
June 10, 2016ANDA204744 Paroxetine
PAROXETINE HYDROCHLORIDE
Lannett Co Inc
May 31, 2016ANDA208278 Amantadine
AMANTADINE HYDROCHLORIDE
Zydus Pharms
May 27, 2016ANDA206121 Oxybutynin
OXYBUTYNIN CHLORIDE
Unique
May 23, 2016ANDA203482 Temazepam
TEMAZEPAM
Amneal Pharms
May 19, 2016ANDA205519 Atorvastatin
ATORVASTATIN CALCIUM
Sciegen Pharms
May 17, 2016ANDA203359 Quetiapine
QUETIAPINE FUMARATE
Macleods Pharms
May 13, 2016ANDA205814 Hydromorphone hydrochloride
HYDROMORPHONE HYDROCHLORIDE
Aurolife Pharma LLC
May 11, 2016ANDA202445 Propafenone hydrochloride
PROPAFENONE HYDROCHLORIDE
Aurobindo Pharma
May 5, 2016ANDA205118 Fenofibrate
FENOFIBRATE
Aurobindo Pharma
April 29, 2016ANDA090295 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Pharmazone
April 21, 2016ANDA205606 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Aurobindo Pharma Ltd
April 12, 2016ANDA202991 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Rhodes Pharms
March 25, 2016ANDA204313 Acyclovir
ACYCLOVIR
Cadila
March 22, 2016ANDA203653 Levalbuterol
LEVALBUTEROL HYDROCHLORIDE
Ritedose Corp
March 16, 2016ANDA204590 Celecoxib
CELECOXIB
Macleods Pharms
March 9, 2016ANDA077342 Sildenafil
SILDENAFIL CITRATE
Teva
March 8, 2016ANDA202674 Quetiapine
QUETIAPINE FUMARATE
Unichem
March 1, 2016ANDA205794 Bupropion
BUPROPION HYDROCHLORIDE
Sciegen Pharms
February 29, 2016ANDA207138 Oxybutynin
OXYBUTYNIN CHLORIDE
Accord Hlthcare
February 23, 2016ANDA204648 Diclofenac
DICLOFENAC POTASSIUM
Bionpharma
February 18, 2016ANDA203269 Rizatriptan benzoate
RIZATRIPTAN BENZOATE
Alkem Labs Ltd
February 18, 2016ANDA204989 Gabapentin
RELGAABI
Sciegen Pharms
February 18, 2016ANDA205115 Doxycycline
DOXYCYCLINE
Zydus Pharms
February 16, 2016ANDA201722 Nitrofurantoin
NITROFURANTOIN
Sun Pharm Industries
February 8, 2016ANDA206083 Valsartan and hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE
Prinston Inc
February 4, 2016ANDA205101 Gabapentin
GABAPENTIN
Sciegen Pharms
January 29, 2016ANDA201760 Buprenorphine
BUPRENORPHINE HYDROCHLORIDE
Sun Pharm
January 28, 2016ANDA203192 Alfuzosin hydrochloride
ALFUZOSIN HYDROCHLORIDE
Unichem
January 26, 2016ANDA205119 Pantoprazole sodium
PANTOPRAZOLE SODIUM
Amneal Pharms
January 13, 2016ANDA205415 Pindolol
PINDOLOL
Mpp Pharma
January 11, 2016ANDA205564 Levocetirizine dihydrochloride
LEVOCETIRIZINE DIHYDROCHLORIDE
Macleods Pharms
December 23, 2015ANDA206402 Gabapentin
GABAPENTIN
Alkem Labs Ltd
December 22, 2015ANDA206530 Famotidine
FAMOTIDINE
Aurobindo Pharma Ltd
December 21, 2015ANDA204239 Linezolid
LINEZOLID
Hetero Labs Ltd V
December 21, 2015ANDA205517 Linezolid
LINEZOLID
Alkem Labs Ltd
December 18, 2015ANDA203455 Nadolol
NADOLOL
Invagen Pharms
December 17, 2015ANDA205973 Perphenazine
PERPHENAZINE
Wilshire Pharms Inc
November 30, 2015ANDA206528 Memantine hydrochloride
MEMANTINE HYDROCHLORIDE
Ajanta Pharma Ltd
November 18, 2015ANDA204237 Rabeprazole sodium
RABEPRAZOLE SODIUM
Rubicon Research
November 5, 2015ANDA204802 Pioglitazone and metformin hydrochloride
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
Macleods Pharms
November 4, 2015ANDA202284 Felbamate
FELBAMATE
Ani Pharms
October 30, 2015ANDA205150 Telmisartan
TELMISARTAN
Adaptis
October 14, 2015ANDA203030 Losartan potassium
LOSARTAN POTASSIUM
Unichem
October 8, 2015ANDA203908 Aripiprazole
ARIPIPRAZOLE
Aurobindo Pharma
October 8, 2015ANDA204290 Montelukast
MONTELUKAST SODIUM
Unichem
September 22, 2015ANDA207416 Methylphenidate
METHYLPHENIDATE HYDROCHLORIDE
Ascent Pharms Inc
September 18, 2015ANDA204582 Buspirone
BUSPIRONE HYDROCHLORIDE
Heritage Pharma
September 17, 2015ANDA079124 Lamivudine and zidovudine
LAMIVUDINE AND ZIDOVUDINE
Hetero Labs Ltd III
September 16, 2015ANDA202726 Gemfibrozil
GEMFIBROZIL
Aurobindo Pharma Ltd
September 15, 2015ANDA091625 Ibuprofen
IBUPROFEN
Granules
August 28, 2015ANDA078032 Escitalopram
ESCITALOPRAM OXALATE
Prinston Inc
August 28, 2015ANDA204310 Raloxifene hydrochloride
RALOXIFENE HYDROCHLORIDE
Aurobindo Pharma
August 26, 2015ANDA203197 Duloxetine
DULOXETINE HYDROCHLORIDE
Alkem Labs Ltd
August 19, 2015ANDA203270 Omeprazole
OMEPRAZOLE
Aurobindo Pharma
August 12, 2015ANDA203835 Losartan potassium
LOSARTAN POTASSIUM
Hetero Labs Ltd V
August 7, 2015ANDA206297 Lidocaine
LIDOCAINE
Amneal Pharms
August 4, 2015ANDA204268 Testosterone
TESTOSTERONE
Padagis Israel
July 31, 2015ANDA202765 Benzonatate
BENZONATATE
Cspc-Nbp Pharm
July 31, 2015ANDA203346 Alprazolam
ALPRAZOLAM
Aurobindo Pharma
July 28, 2015ANDA204418 Folic acid
FOLIC ACID
Nuvo Pharms Inc
June 29, 2015ANDA204003 Desvenlafaxine
DESVENLAFAXINE SUCCINATE
Alembic
June 29, 2015ANDA204028 Desvenlafaxine
DESVENLAFAXINE SUCCINATE
Rubicon Research
June 29, 2015ANDA204172 Desvenlafaxine
DESVENLAFAXINE SUCCINATE
Lupin
June 10, 2015ANDA204309 Phenytoin
EXTENDED PHENYTOIN SODIUM
Aurobindo Pharma
June 9, 2015ANDA204821 Valsartan
VALSARTAN
Prinston Inc
June 2, 2015ANDA204197 Celecoxib
CELECOXIB
Apotex
June 1, 2015ANDA204979 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE
Ani Pharms
May 29, 2015ANDA203974 Metronidazole
METRONIDAZOLE
Aurobindo Pharma Ltd
May 26, 2015ANDA202304 Bupropion
BUPROPION HYDROCHLORIDE
Prinston Inc
May 22, 2015ANDA204093 Montelukast
MONTELUKAST SODIUM
Hetero Labs Ltd V
May 22, 2015ANDA204633 Acitretin
ACITRETIN
Sigmapharm Labs LLC
May 21, 2015ANDA201749 Methotrexate
METHOTREXATE SODIUM
Sun Pharm
May 21, 2015ANDA203468 Levetiracetam
LEVETIRACETAM
Prinston Inc
May 12, 2015ANDA203518 Morphine sulfate
MORPHINE SULFATE
Tris Pharma Inc
April 28, 2015ANDA201519 Aripiprazole
ARIPIPRAZOLE
Torrent
April 28, 2015ANDA205064 Aripiprazole
ARIPIPRAZOLE
Hetero Labs Ltd V
April 20, 2015ANDA077770 Desoximetasone
DESOXIMETASONE
Padagis Israel
April 16, 2015ANDA090218 Glatiramer acetate
GLATOPA
Sandoz
April 8, 2015ANDA203047 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE
Hetero Labs Ltd V
March 16, 2015ANDA204597 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Sciegen Pharms
January 30, 2015ANDA078830 Scopolamine
SCOPOLAMINE
Difgen Pharms
January 30, 2015ANDA202929 Eszopiclone
ESZOPICLONE
Macleods Pharms
January 8, 2015ANDA202801 Levofloxacin
LEVOFLOXACIN
Hetero Labs Ltd V
January 5, 2015ANDA203311 Valsartan
VALSARTAN
Hetero Labs Ltd V
December 30, 2014ANDA202557 Buspirone
BUSPIRONE HYDROCHLORIDE
Accord Hlthcare
December 12, 2014ANDA091356 Calcitriol
CALCITRIOL
Onesource Specialty
December 12, 2014ANDA200174 Calcipotriene and betamethasone dipropionate (betamethasone dipropionate / calcipotriene)
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
Padagis Israel
December 5, 2014ANDA205019 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Nuvo Pharm
November 28, 2014ANDA204071 Sodium polystyrene sulfonate
SODIUM POLYSTYRENE SULFONATE
Nuvo Pharms Inc
November 26, 2014ANDA203623 Sildenafil
SILDENAFIL CITRATE
Hetero Labs Ltd V
November 7, 2014ANDA202825 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE
Accord Hlthcare
October 31, 2014ANDA091672 Omeprazole
OMEPRAZOLE
Glenmark Pharms Ltd
October 31, 2014ANDA203854 Paroxetine
PAROXETINE
Prinston Inc
October 29, 2014ANDA203104 Donepezil hydrochloride
DONEPEZIL HYDROCHLORIDE
Twi Pharms
October 28, 2014ANDA200981 Metoprolol
METOPROLOL TARTRATE
Rubicon Research
September 25, 2014ANDA205008 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Nuvo Pharm
September 25, 2014ANDA205017 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Nuvo Pharm
September 15, 2014ANDA204165 Clopidogrel
CLOPIDOGREL BISULFATE
Sciegen Pharms
September 10, 2014ANDA202438 Famciclovir
FAMCICLOVIR
Hetero Labs Ltd V
September 10, 2014ANDA202843 Montelukast
MONTELUKAST SODIUM
Hetero Labs Ltd V
September 10, 2014ANDA202882 Pantoprazole sodium
PANTOPRAZOLE SODIUM
Hetero Labs Ltd V
September 9, 2014ANDA203646 Levocetirizine dihydrochloride
LEVOCETIRIZINE DIHYDROCHLORIDE
Sciegen Pharms
August 28, 2014ANDA201278 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN
Rhodes Pharms
August 25, 2014ANDA202330 Buspirone
BUSPIRONE HYDROCHLORIDE
Strides Pharma
August 20, 2014ANDA204279 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Heritage
August 15, 2014ANDA202862 Olanzapine
OLANZAPINE
Macleods Pharms Ltd
July 15, 2014ANDA205292 Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Padagis Us
July 7, 2014ANDA090032 Telmisartan
TELMISARTAN
Glenmark Pharms Ltd
June 27, 2014ANDA203326 Buprenorphine and naloxone
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Hikma
June 11, 2014ANDA202824 Doxazosin
DOXAZOSIN MESYLATE
Accord Hlthcare
June 11, 2014ANDA203088 Duloxetine
DULOXETINE HYDROCHLORIDE
Breckenridge
June 4, 2014ANDA202446 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE
Accord Hlthcare
June 4, 2014ANDA203775 Cevimeline hydrochloride
CEVIMELINE HYDROCHLORIDE
Rising
June 3, 2014ANDA203638 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE
Amneal Pharms
June 2, 2014ANDA202419 Divalproex sodium
DIVALPROEX SODIUM
Aurobindo Pharma Ltd
May 9, 2014ANDA203072 Irbesartan and hydrochlorothiazide
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Prinston Inc
April 23, 2014ANDA203253 Spironolactone
SPIRONOLACTONE
Jubilant Generics
April 15, 2014ANDA091166 Eszopiclone
ESZOPICLONE
Glenmark Pharms Ltd
April 3, 2014ANDA203126 Nifedipine
NIFEDIPINE
Twi Pharms
March 27, 2014ANDA202539 Paricalcitol
PARICALCITOL
Bionpharma
March 12, 2014ANDA091159 Methylphenidate
METHYLPHENIDATE HYDROCHLORIDE
Mountain
March 6, 2014ANDA202187 Spironolactone
SPIRONOLACTONE
Aurobindo Pharma
March 4, 2014ANDA076938 Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE
DR Reddys
March 4, 2014ANDA078193 Raloxifene hydrochloride
RALOXIFENE HYDROCHLORIDE
Teva Pharms USA
March 4, 2014ANDA202632 Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE
Aurobindo Pharma Ltd
February 11, 2014ANDA203147 Rizatriptan benzoate
RIZATRIPTAN BENZOATE
Macleods Pharms
February 10, 2014ANDA202928 Clopidogrel
CLOPIDOGREL BISULFATE
Macleods Pharms
February 7, 2014ANDA078888 Buspirone
BUSPIRONE HYDROCHLORIDE
Zydus Pharms
February 3, 2014ANDA091182 Glycopyrrolate
GLYCOPYRROLATE
Regcon Holdings
January 27, 2014ANDA202437 Folic acid
FOLIC ACID
Cadila Pharms Ltd
January 27, 2014ANDA203374 Carisoprodol
CARISOPRODOL
Sciegen Pharms
January 23, 2014ANDA091134 Etodolac
ETODOLAC
Zydus Pharms
January 22, 2014ANDA203458 Metronidazole
METRONIDAZOLE
Unichem
January 22, 2014ANDA203820 Repaglinide
REPAGLINIDE
Aurobindo Pharma Ltd
January 10, 2014ANDA077210 Pioglitazone
PIOGLITAZONE HYDROCHLORIDE
Teva Pharms USA
January 8, 2014NDA202293 Dapagliflozin
FARXIGA
Astrazeneca Ab
December 17, 2013ANDA090776 Duloxetine
DULOXETINE HYDROCHLORIDE
Actavis Elizabeth
December 17, 2013ANDA203814 Sildenafil
SILDENAFIL CITRATE
Macleods Pharms
December 11, 2013ANDA090694 Duloxetine
DULOXETINE HYDROCHLORIDE
Lupin
November 27, 2013ANDA202180 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE
Torrent
November 27, 2013ANDA202424 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Aurolife Pharma LLC
November 18, 2013ANDA078992 Dexmethylphenidate hydrochloride
DEXMETHYLPHENIDATE HYDROCHLORIDE
Platinum
November 8, 2013ANDA090678 Rabeprazole sodium
RABEPRAZOLE SODIUM
Lannett Co Inc
October 29, 2013ANDA203834 Acyclovir
ACYCLOVIR
Hetero Labs Ltd V
October 21, 2013ANDA203245 Amlodipine
AMLODIPINE BESYLATE
Unichem
October 17, 2013ANDA200672 Lamotrigine
LAMOTRIGINE
Actavis Elizabeth
October 11, 2013ANDA090549 Penicillin v potassium
PENICILLIN V POTASSIUM
Hikma Pharms
September 17, 2013ANDA202046 Levocetirizine dihydrochloride
LEVOCETIRIZINE DIHYDROCHLORIDE
Micro Labs Ltd India
September 11, 2013ANDA078970 Zolpidem tartrate
ZOLPIDEM TARTRATE
Lupin
September 11, 2013ANDA203769 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Sciegen Pharms
August 21, 2013ANDA090034 Rifampin
RIFAMPIN
Lupin Pharms
August 16, 2013ANDA200900 Progesterone
PROGESTERONE
Bionpharma
August 9, 2013ANDA202847 Fluocinolone acetonide
FLUOCINOLONE ACETONIDE
Padagis Israel
August 9, 2013ANDA202848 Fluocinolone acetonide
FLUOCINOLONE ACETONIDE
Padagis Israel
August 8, 2013ANDA091681 Disulfiram
DISULFIRAM
Alvogen
July 26, 2013ANDA091693 Ramelteon
RAMELTEON
DR Reddys Labs SA
July 15, 2013ANDA201972 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN
Aurolife Pharma LLC
July 12, 2013ANDA091145 Folic acid
FOLIC ACID
Aiping Pharm Inc
July 12, 2013ANDA203244 Gabapentin
GABAPENTIN
Strides Pharma
July 9, 2013ANDA091695 Methylphenidate
METHYLPHENIDATE HYDROCHLORIDE
Lannett Co Inc
July 8, 2013ANDA091591 Cevimeline hydrochloride
CEVIMELINE HYDROCHLORIDE
Hikma
July 1, 2013ANDA203062 Rizatriptan benzoate
RIZATRIPTAN BENZOATE
Aurobindo Pharma Ltd
June 13, 2013ANDA202297 Clonidine
CLONIDINE HYDROCHLORIDE
Yung Shin Pharm
June 3, 2013ANDA201507 Hydroxyzine
HYDROXYZINE PAMOATE
Heritage Pharma
May 29, 2013ANDA203644 Dextroamphetamine
DEXTROAMPHETAMINE SULFATE
Tris Pharma Inc
May 28, 2013ANDA202871 Metoprolol
METOPROLOL TARTRATE
Alembic Pharms Ltd
May 24, 2013ANDA091174 Calcitriol
CALCITRIOL
Bionpharma
May 24, 2013ANDA201291 Trospium chloride
TROSPIUM CHLORIDE
Padagis Us
May 6, 2013ANDA203154 Allopurinol
ALLOPURINOL
Accord Hlthcare
April 30, 2013ANDA202433 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE
Aurobindo Pharma Ltd
April 29, 2013ANDA202725 Quinapril
QUINAPRIL HYDROCHLORIDE
Aurobindo Pharma Ltd
April 19, 2013ANDA203145 Valsartan and hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE
Macleods Pharms Ltd
April 17, 2013ANDA202112 Glimepiride
GLIMEPIRIDE
Regcon Holdings
April 15, 2013ANDA202675 Glycopyrrolate
GLYCOPYRROLATE
Aurobindo Pharma
April 15, 2013ANDA202800 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Aurolife Pharma LLC
March 27, 2013ANDA202214 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Tris Pharma Inc
March 21, 2013ANDA201662 Valsartan and hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE
Alembic
March 4, 2013ANDA202202 Warfarin sodium
WARFARIN SODIUM
Amneal Pharms
February 28, 2013ANDA202025 Sildenafil
SILDENAFIL CITRATE
Amneal Pharms
February 22, 2013ANDA203136 Buprenorphine and naloxone
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Amneal Pharms
February 14, 2013ANDA202540 Ursodiol
URSODIOL
Ph Health
February 13, 2013ANDA200268 Pioglitazone
PIOGLITAZONE HYDROCHLORIDE
Aurobindo Pharma Ltd
February 12, 2013ANDA201504 Quetiapine
QUETIAPINE FUMARATE
Alkem Labs Ltd
January 31, 2013ANDA091281 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Twi Pharms Inc
January 25, 2013NDA022271 Alogliptin
NESINA
Takeda Pharms USA
January 17, 2013ANDA203417 Felodipine
FELODIPINE
Aurobindo Pharma Ltd
December 31, 2012ANDA202490 Rizatriptan benzoate
RIZATRIPTAN BENZOATE
Aurobindo Pharma Ltd
December 27, 2012ANDA202093 Tranexamic acid
TRANEXAMIC ACID
Actavis Labs Fl Inc
December 12, 2012ANDA079059 Risperidone
RISPERIDONE
Tris Pharma Inc
December 7, 2012ANDA202856 Fenofibrate
FENOFIBRATE
Mylan Pharms Inc
November 29, 2012ANDA200295 Liothyronine sodium
LIOTHYRONINE SODIUM
Sigmapharm Labs LLC
November 28, 2012ANDA079229 Ropinirole
ROPINIROLE HYDROCHLORIDE
Orbion Pharms
November 28, 2012ANDA091283 Tizanidine
TIZANIDINE HYDROCHLORIDE
Unichem Labs Ltd
November 19, 2012ANDA091352 Omeprazole
OMEPRAZOLE
Zydus Pharms USA Inc
November 19, 2012ANDA202160 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE
Aurolife Pharma LLC
November 6, 2012ANDA091479 Sildenafil
SILDENAFIL CITRATE
Torrent Pharms Ltd
October 26, 2012ANDA202633 Pramipexole dihydrochloride
PRAMIPEXOLE DIHYDROCHLORIDE
Aurobindo Pharma Ltd
October 24, 2012ANDA040903 Imipramine
IMIPRAMINE HYDROCHLORIDE
Leading
October 24, 2012ANDA201687 Tretinoin
TRETINOIN
Ph Health
October 15, 2012ANDA090351 Irbesartan and hydrochlorothiazide
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Hikma
October 3, 2012ANDA202254 Irbesartan
IRBESARTAN
Macleods Pharms Ltd
September 28, 2012ANDA201807 Indomethacin
INDOMETHACIN
Hetero Labs Ltd III
September 28, 2012ANDA202038 Pantoprazole sodium
PANTOPRAZOLE SODIUM
Aurobindo Pharma Ltd
September 28, 2012ANDA202248 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Elite Labs
September 27, 2012ANDA202414 Irbesartan and hydrochlorothiazide
IRBESARTAN AND HYDROCHLOROTHIAZIDE, IRBESARTAN; HYDROCHLOROTHIAZIDE
Macleods Pharms Ltd
September 27, 2012ANDA202566 Modafinil
MODAFINIL
Aurobindo Pharma Ltd
September 27, 2012ANDA202910 Irbesartan
IRBESARTAN
Hetero Labs Ltd V
September 27, 2012ANDA203071 Irbesartan
IRBESARTAN
Prinston Inc
September 24, 2012ANDA091541 Losartan potassium
LOSARTAN POTASSIUM
Micro Labs
September 24, 2012ANDA200602 Methscopolamine bromide
METHSCOPOLAMINE BROMIDE
Unichem
September 24, 2012ANDA202556 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Accord Hlthcare
September 21, 2012ANDA090195 Glycopyrrolate
GLYCOPYRROLATE
Velzen Pharma Pvt
September 21, 2012ANDA202717 Montelukast
MONTELUKAST SODIUM
Accord Hlthcare
September 18, 2012ANDA201170 Losartan potassium
LOSARTAN POTASSIUM
Jubilant Cadista
September 18, 2012ANDA201845 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Jubilant Cadista
September 17, 2012ANDA202640 Meclizine hydrochloride
MECLIZINE HYDROCHLORIDE
Aurobindo Pharma USA
September 17, 2012ANDA202961 Oxcarbazepine
OXCARBAZEPINE
Amneal Pharms
September 13, 2012ANDA200243 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Lannett Co Inc
September 11, 2012ANDA078777 Escitalopram
ESCITALOPRAM OXALATE
Graviti Pharms
September 11, 2012ANDA090432 Escitalopram
ESCITALOPRAM OXALATE
Aurobindo Pharma Ltd
September 11, 2012ANDA090939 Escitalopram
ESCITALOPRAM OXALATE
Torrent Pharms Ltd
September 11, 2012ANDA202389 Escitalopram
ESCITALOPRAM OXALATE
Accord Hlthcare
September 7, 2012ANDA077652 Levofloxacin
LEVOFLOXACIN
Zydus Lifesciences
September 5, 2012ANDA202239 Amlodipine besylate and benazepril hydrochloride
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Aurobindo Pharma Ltd
August 30, 2012ANDA079060 Alfuzosin hydrochloride
ALFUZOSIN HYDROCHLORIDE
Aurobindo Pharma Ltd
August 28, 2012ANDA201821 Clindamycin palmitate hydrochloride
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Rising
August 23, 2012ANDA200675 Lidocaine
LIDOCAINE
Actavis Labs Ut Inc
August 17, 2012ANDA201146 Donepezil hydrochloride
DONEPEZIL HYDROCHLORIDE
Macleods Pharms Ltd
August 15, 2012ANDA078889 Metoprolol
METOPROLOL SUCCINATE
Reddys
August 9, 2012ANDA090974 Clobetasol propionate
CLOBETASOL PROPIONATE
Padagis Israel
August 9, 2012ANDA200166 Amphetamine
EVEKEO
Azurity
August 9, 2012ANDA202289 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Macleods Pharms Ltd
August 1, 2012ANDA090617 Metoprolol
METOPROLOL SUCCINATE
DR Reddys Labs Ltd
July 26, 2012ANDA202677 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN
Alvogen
July 26, 2012NDA202057 Icosapent ethyl
VASCEPA
Amarin Pharms
July 25, 2012ANDA065489 Clarithromycin
CLARITHROMYCIN
Aurobindo
June 29, 2012ANDA091220 Glimepiride
GLIMEPIRIDE
Micro Labs
June 29, 2012ANDA091264 Levocetirizine dihydrochloride
LEVOCETIRIZINE DIHYDROCHLORIDE
Hetero Labs Ltd III
June 29, 2012ANDA200386 Promethazine hydrochloride and codeine phosphate
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Cosette Pharms Nc
June 29, 2012ANDA202759 Glimepiride
GLIMEPIRIDE
Aurobindo Pharma Ltd
June 28, 2012ANDA091687 Promethazine hydrochloride and dextromethorphan hydrobromide
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Cosette Pharms Nc
June 15, 2012ANDA091586 Theophylline
THEOPHYLLINE
Tris Pharma Inc
June 14, 2012ANDA200298 Adapalene
ADAPALENE
Encube Ethicals
June 12, 2012ANDA078407 Fluvastatin
FLUVASTATIN SODIUM
Teva Pharms
June 1, 2012ANDA200043 Armodafinil
ARMODAFINIL
Mylan Pharms Inc
May 29, 2012ANDA090548 Atorvastatin
ATORVASTATIN CALCIUM
Apotex Inc
May 17, 2012ANDA090540 Clopidogrel
CLOPIDOGREL BISULFATE
Aurobindo Pharma Ltd
May 11, 2012ANDA078761 Morphine sulfate
MORPHINE SULFATE
Sun Pharm Inds Ltd
May 3, 2012ANDA091347 Vardenafil
VARDENAFIL HYDROCHLORIDE
Teva Pharms
May 1, 2012ANDA076403 Gabapentin
GABAPENTIN
Acella Pharms LLC
May 1, 2012ANDA091244 Testosterone cypionate
TESTOSTERONE CYPIONATE
Hikma Farmaceutica
April 23, 2012ANDA076255 Olanzapine
OLANZAPINE
DR Reddys Labs Ltd
April 23, 2012ANDA090798 Olanzapine
OLANZAPINE
Apotex Inc
April 23, 2012ANDA202050 Olanzapine
OLANZAPINE
Aurobindo Pharma Ltd
April 19, 2012ANDA078355 Desloratadine
DESLORATADINE
Ajenat Pharms
April 11, 2012ANDA090079 Levetiracetam
LEVETIRACETAM
Quagen
April 11, 2012ANDA201013 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Aurolife Pharma LLC
March 30, 2012ANDA077369 Irbesartan and hydrochlorothiazide
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Teva
March 27, 2012ANDA091388 Quetiapine
QUETIAPINE FUMARATE
Aurobindo Pharma Ltd
March 27, 2012ANDA201109 Quetiapine
QUETIAPINE FUMARATE
Lupin Ltd
March 27, 2012ANDA201190 Quetiapine
QUETIAPINE FUMARATE
Sun Pharm
March 27, 2012ANDA202152 Quetiapine
QUETIAPINE FUMARATE
Accord Hlthcare
March 15, 2012ANDA090710 Methylphenidate
METHYLPHENIDATE HYDROCHLORIDE
Sun Pharm Inds Inc
March 7, 2012ANDA202068 Methimazole
METHIMAZOLE
Rising
March 2, 2012ANDA077561 Ziprasidone
ZIPRASIDONE HYDROCHLORIDE
Apotex
March 2, 2012ANDA077565 Ziprasidone
ZIPRASIDONE HYDROCHLORIDE
DR Reddys Labs Inc
February 29, 2012ANDA091595 Ciclopirox
CICLOPIROX
Glenmark Pharms
February 24, 2012ANDA090356 Naltrexone hydrochloride
NALTREXONE HYDROCHLORIDE
Sun Pharm
February 7, 2012ANDA202271 Acarbose
ACARBOSE
Avet Lifesciences
January 25, 2012ANDA090502 Lactulose
LACTULOSE
Fresenius Kabi
January 20, 2012ANDA091568 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Aurobindo Pharma Ltd
January 18, 2012ANDA201991 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Adaptis
January 12, 2012ANDA201022 Famciclovir
FAMCICLOVIR
Macleods Pharms Ltd
December 12, 2011ANDA200265 Voriconazole
VORICONAZOLE
Sandoz Inc
December 9, 2011ANDA201407 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Lannett Co Inc
December 7, 2011ANDA201384 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Sun Pharm
December 6, 2011ANDA091368 Clonidine
CLONIDINE HYDROCHLORIDE
Alembic Pharms Ltd
November 30, 2011ANDA076477 Atorvastatin
ATORVASTATIN CALCIUM
Sun Pharm Inds Ltd
November 29, 2011ANDA077493 Risperidone
RISPERIDONE
Prinston Inc
November 28, 2011ANDA202075 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Strides Pharma
November 28, 2011ANDA202170 Felodipine
FELODIPINE
Torrent Pharms Ltd
November 25, 2011ANDA078986 Carbamazepine
CARBAMAZEPINE
Apotex Inc
November 8, 2011ANDA200429 Naproxen
NAPROXEN
Aurobindo Pharma
November 7, 2011ANDA091263 Levocetirizine dihydrochloride
LEVOCETIRIZINE DIHYDROCHLORIDE
Padagis Us
October 31, 2011ANDA200629 Naproxen
NAPROXEN SODIUM
Aurobindo Pharma Ltd
October 28, 2011ANDA200815 Felodipine
FELODIPINE
Ph Health
October 25, 2011ANDA090533 Dextroamphetamine
DEXTROAMPHETAMINE SULFATE
Azurity
October 24, 2011ANDA091265 Olanzapine
OLANZAPINE
Apotex Inc
October 24, 2011ANDA091680 Diethylpropion hydrochloride
DIETHYLPROPION HYDROCHLORIDE
Lannett Co Inc
October 6, 2011ANDA090170 Lamotrigine
LAMOTRIGINE
Unichem Labs Ltd
October 6, 2011ANDA200651 Gabapentin
GABAPENTIN
Aurobindo Pharma Ltd
September 19, 2011ANDA091432 Naproxen
NAPROXEN
Nuvo Pharms Inc
August 31, 2011ANDA091195 Tacrolimus
TACROLIMUS
Accord Hlthcare
August 29, 2011ANDA200503 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Lupin Ltd
August 25, 2011ANDA091550 Ketoconazole
KETOCONAZOLE
Padagis Israel
August 24, 2011ANDA201003 Risperidone
RISPERIDONE
Ajanta Pharma Ltd
August 17, 2011ANDA091205 Naltrexone hydrochloride
NALTREXONE HYDROCHLORIDE
Accord Hlthcare
July 27, 2011ANDA090912 Acarbose
ACARBOSE
Strides Pharma
July 21, 2011ANDA090007 Gabapentin
GABAPENTIN
Pharmazone
July 18, 2011ANDA079057 Alfuzosin hydrochloride
ALFUZOSIN HYDROCHLORIDE
Sun Pharm
July 18, 2011ANDA200177 Diethylpropion hydrochloride
DIETHYLPROPION HYDROCHLORIDE
Lannett Co Inc
July 15, 2011ANDA078703 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE
Adare Pharms Inc
July 1, 2011ANDA090107 Zolpidem tartrate
ZOLPIDEM TARTRATE
Sandoz
June 29, 2011ANDA090692 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Lupin Ltd
June 13, 2011ANDA091083 Nabumetone
NABUMETONE
Watson Labs
June 8, 2011ANDA091604 Ramipril
RAMIPRIL
Aurobindo Pharma Ltd
June 7, 2011ANDA090871 Alprazolam
ALPRAZOLAM
Aurobindo Pharma
June 6, 2011ANDA091497 Losartan potassium
LOSARTAN POTASSIUM
Prinston Inc
June 3, 2011ANDA090934 Letrozole
LETROZOLE
Accord Hlthcare
June 3, 2011ANDA200161 Letrozole
LETROZOLE
Natco Pharma Ltd
May 31, 2011ANDA090056 Donepezil hydrochloride
DONEPEZIL HYDROCHLORIDE
Aurobindo
May 31, 2011ANDA200292 Donepezil hydrochloride
DONEPEZIL HYDROCHLORIDE
Prinston Inc
April 21, 2011ANDA090554 Divalproex sodium
DIVALPROEX SODIUM
Aurobindo Pharma Ltd
April 14, 2011ANDA090174 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Zydus Pharms USA Inc
April 14, 2011ANDA200834 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Aurobindo Pharma Ltd
April 12, 2011ANDA091240 Indomethacin
INDOMETHACIN
Hetero Labs Ltd III
April 5, 2011ANDA079163 Divalproex sodium
DIVALPROEX SODIUM
Unichem Labs Ltd
March 29, 2011ANDA090957 Galantamine
GALANTAMINE HYDROBROMIDE
Aurobindo Pharma Ltd
March 9, 2011ANDA091490 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE
Rhodes Pharms
March 7, 2011ANDA078423 Fluconazole
FLUCONAZOLE
Ani Pharms
February 28, 2011ANDA090937 Glyburide
GLYBURIDE
Heritage
February 14, 2011ANDA091416 Naproxen
NAPROXEN
Pharmazone
February 2, 2011ANDA090178 Galantamine
GALANTAMINE HYDROBROMIDE
Sun Pharm
January 31, 2011ANDA200272 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Elite Labs
January 20, 2011ANDA078281 Pantoprazole sodium
PANTOPRAZOLE SODIUM
Lannett Co Inc
January 19, 2011ANDA090970 Pantoprazole sodium
PANTOPRAZOLE SODIUM
Mylan Pharms Inc
January 12, 2011ANDA091211 Atovaquone and proguanil hydrochloride
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
Glenmark Pharms Ltd
December 22, 2010ANDA091276 Indomethacin
INDOMETHACIN
Glenmark Pharms Ltd
December 22, 2010ANDA201212 Diethylpropion hydrochloride
DIETHYLPROPION HYDROCHLORIDE
Avanthi Inc
December 21, 2010ANDA090796 Ibuprofen
IBUPROFEN
Pharmazone
December 20, 2010ANDA090836 Cephalexin
CEPHALEXIN
Alkem Labs Ltd
December 17, 2010ANDA090365 Felodipine
FELODIPINE
Glenmark Pharms Ltd
December 17, 2010ANDA090858 Gabapentin
GABAPENTIN
Alkem
December 14, 2010ANDA078932 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Alembic Pharms Ltd
December 14, 2010ANDA091491 Levetiracetam
LEVETIRACETAM
Zhejiang Jingxin
December 1, 2010ANDA090066 Diclofenac
DICLOFENAC SODIUM
Unique
November 19, 2010ANDA090562 Mefenamic acid
MEFENAMIC ACID
Micro Labs
November 17, 2010ANDA091573 Trospium chloride
TROSPIUM CHLORIDE
Padagis Us
October 25, 2010ANDA078352 Desloratadine
DESLORATADINE
Lupin Pharms
October 15, 2010ANDA091269 Lansoprazole
LANSOPRAZOLE
DR Reddys Labs Ltd
October 8, 2010ANDA090515 Levetiracetam
LEVETIRACETAM
Hetero Labs Ltd III
October 8, 2010ANDA090865 Pramipexole dihydrochloride
PRAMIPEXOLE DIHYDROCHLORIDE
Torrent Pharms
October 6, 2010ANDA078243 Losartan potassium
LOSARTAN POTASSIUM
Zydus Pharms USA Inc
October 6, 2010ANDA090083 Losartan potassium
LOSARTAN POTASSIUM
Aurobindo Pharma
October 6, 2010ANDA091629 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Aurobindo Pharma
October 1, 2010ANDA091632 Hydrocodone polistirex and chlorpheniramine polistirex
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
Tris Pharma Inc
September 13, 2010ANDA040889 Methylergonovine maleate
METHYLERGONOVINE MALEATE
Breckenridge
September 7, 2010ANDA078837 Imiquimod
IMIQUIMOD
Padagis Israel
August 31, 2010ANDA091042 Phendimetrazine tartrate
PHENDIMETRAZINE TARTRATE
Kvk Tech
August 20, 2010ANDA040879 Hydrocortisone
HYDROCORTISONE
Rising
August 3, 2010ANDA090455 Ergocalciferol
ERGOCALCIFEROL
Onesource
July 28, 2010ANDA079106 Bisoprolol fumarate and hydrochlorothiazide
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Unichem
July 23, 2010ANDA091601 Methylphenidate
METHYLPHENIDATE HYDROCHLORIDE
Tris Pharma Inc
July 20, 2010ANDA090968 Benzphetamine hydrochloride
BENZPHETAMINE HYDROCHLORIDE
Kvk Tech
July 2, 2010ANDA091426 Spironolactone
SPIRONOLACTONE
Amneal Pharms
June 30, 2010ANDA090824 Adapalene
ADAPALENE
Fougera Pharms
June 28, 2010ANDA078921 Anastrozole
ANASTROZOLE
Zydus Pharms USA Inc
June 28, 2010ANDA079220 Anastrozole
ANASTROZOLE
Natco Pharma Ltd
June 28, 2010ANDA090568 Anastrozole
ANASTROZOLE
Accord Hlthcare
June 21, 2010ANDA076968 Paroxetine
PAROXETINE HYDROCHLORIDE
Oxford Pharms
June 4, 2010ANDA040659 Meclizine hydrochloride
MECLIZINE HYDROCHLORIDE
Jubilant Cadista
June 4, 2010ANDA077714 Terbinafine hydrochloride
TERBINAFINE HYDROCHLORIDE
Breckenridge Pharm
May 24, 2010ANDA078518 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE
Mylan Pharms Inc
May 24, 2010ANDA090682 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE
Aurobindo Pharma
May 21, 2010ANDA078245 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Lupin Ltd
May 5, 2010ANDA090058 Memantine hydrochloride
MEMANTINE HYDROCHLORIDE
Sun Pharm
April 27, 2010ANDA078225 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE
Zydus Pharms USA Inc
April 22, 2010ANDA090564 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Granules India
April 12, 2010ANDA090469 Ondansetron
ONDANSETRON
Aurobindo Pharma
April 7, 2010ANDA090555 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Aurobindo Pharma
March 31, 2010ANDA090785 Clindamycin
CLINDAMYCIN PHOSPHATE
Padagis Israel
March 24, 2010ANDA090429 Ropinirole
ROPINIROLE HYDROCHLORIDE
Alembic Ltd
February 25, 2010ANDA090135 Ropinirole
ROPINIROLE HYDROCHLORIDE
Glenmark Pharms Ltd
February 23, 2010ANDA090121 Finasteride
FINASTERIDE
Accord Hlthcare
February 16, 2010ANDA090624 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Aurobindo Pharma
February 5, 2010ANDA078466 Amlodipine besylate and benazepril hydrochloride
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Lupin Pharms
January 19, 2010ANDA090510 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Unichem
December 30, 2009ANDA090705 Gabapentin
GABAPENTIN
Invagen Pharms
December 9, 2009ANDA090485 Tramadol hydrochloride and acetaminophen
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Amneal Pharms
November 25, 2009ANDA090635 Methadone hydrochloride
METHADONE HYDROCHLORIDE
Thepharmanetwork LLC
November 18, 2009ANDA090604 Dorzolamide hydrochloride and timolol maleate
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Sandoz
November 6, 2009ANDA090200 Methocarbamol
METHOCARBAMOL
Hetero Labs Ltd III
October 8, 2009ANDA078633 Buprenorphine
BUPRENORPHINE HYDROCHLORIDE
Hikma
September 25, 2009ANDA090702 Lithium carbonate
LITHIUM CARBONATE
Hetero Labs Ltd III
September 17, 2009ANDA090374 Zaleplon
ZALEPLON
Orbion Pharms
August 31, 2009ANDA091393 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE
Avanthi Inc
August 26, 2009ANDA078895 Clonidine
CLONIDINE HYDROCHLORIDE
Unichem
August 18, 2009ANDA078635 Bisoprolol fumarate
BISOPROLOL FUMARATE
Unichem
August 10, 2009ANDA065461 Tacrolimus
TACROLIMUS
Sandoz
August 6, 2009ANDA040792 Carisoprodol
CARISOPRODOL
Aurobindo Pharma
July 29, 2009NDA022352 Colchicine
COLCRYS
Takeda Pharms USA
July 14, 2009ANDA090037 Dorzolamide hydrochloride and timolol maleate
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Bausch and Lomb
July 6, 2009ANDA078917 Bicalutamide
BICALUTAMIDE
Accord Hlthcare
June 16, 2009NDA022202 Diclofenac
ZIPSOR
Cosette
June 3, 2009ANDA079009 Glyburide and metformin hydrochloride
GLYBURIDE AND METFORMIN HYDROCHLORIDE
Heritage
May 22, 2009ANDA078916 Famotidine
FAMOTIDINE
Alembic Pharms Ltd
May 4, 2009ANDA065416 Mycophenolate mofetil
MYCOPHENOLATE MOFETIL
Accord Hlthcare
May 4, 2009ANDA078925 Amlodipine
AMLODIPINE BESYLATE
Alkem
March 27, 2009ANDA076343 Topiramate
TOPIRAMATE
Cipla Ltd
March 27, 2009ANDA078235 Topiramate
TOPIRAMATE
Zydus Pharms USA Inc
March 27, 2009ANDA090162 Topiramate
TOPIRAMATE
Unichem Labs Ltd
March 27, 2009ANDA090278 Topiramate
TOPIRAMATE
Sun Pharm
March 24, 2009ANDA079095 Bupropion
BUPROPION HYDROCHLORIDE
Actavis Labs Fl Inc
March 13, 2009ANDA040891 Promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE
Strides Pharma
March 13, 2009ANDA079067 Metronidazole
METRONIDAZOLE
Alembic Pharms Ltd
March 6, 2009ANDA079175 Indomethacin
INDOMETHACIN
Avanthi Inc
February 27, 2009ANDA078246 Buspirone
BUSPIRONE HYDROCHLORIDE
Aurobindo Pharma Ltd
February 10, 2009ANDA078106 Levetiracetam
LEVETIRACETAM
Prinston Inc
February 5, 2009ANDA078329 Ibuprofen
IBUPROFEN
Strides Pharma
February 3, 2009ANDA079139 Lithium carbonate
LITHIUM CARBONATE
Glenmark Pharms Ltd
January 27, 2009ANDA077633 Lamotrigine
LAMOTRIGINE
Zydus Pharms USA
January 27, 2009ANDA078525 Lamotrigine
LAMOTRIGINE
Taro Pharm Inds
January 27, 2009ANDA079132 Lamotrigine
LAMOTRIGINE
Jubilant Cadista
January 27, 2009ANDA079234 Torsemide
TORSEMIDE
Hetero Labs Ltd III
January 15, 2009ANDA078154 Levetiracetam
LEVETIRACETAM
Lupin
January 15, 2009ANDA078858 Levetiracetam
LEVETIRACETAM
Torrent Pharms
January 12, 2009ANDA040796 Folic acid
FOLIC ACID
Leading
January 7, 2009ANDA078266 Ciclopirox
CICLOPIROX
Padagis Us
December 1, 2008ANDA040864 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Granules
November 25, 2008ANDA078853 Divalproex sodium
DIVALPROEX SODIUM
Orbion Pharms
November 6, 2008ANDA078578 Amiodarone hydrochloride
AMIODARONE HYDROCHLORIDE
Rubicon Research
October 28, 2008ANDA078536 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA
Sun Pharm Inds
October 7, 2008ANDA077731 Fluconazole
FLUCONAZOLE
Aurobindo Pharma
September 26, 2008ANDA078643 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Aurobindo Pharma
September 24, 2008ANDA078420 Nabumetone
NABUMETONE
Sciegen Pharms
September 12, 2008ANDA040901 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE
Hetero Labs Ltd III
August 15, 2008ANDA040907 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Unichem
July 29, 2008ANDA078597 Divalproex sodium
DIVALPROEX SODIUM
Sun Pharm Inds
June 13, 2008ANDA077653 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Zydus Pharms USA
June 9, 2008ANDA077626 Ramipril
RAMIPRIL
Lupin
June 6, 2008ANDA078829 Zaleplon
ZALEPLON
Aurobindo Pharma
June 6, 2008ANDA078989 Zaleplon
ZALEPLON
Unichem
June 2, 2008ANDA078955 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE
Ipca Labs Ltd
May 29, 2008ANDA040779 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Amneal Pharms Ny
May 22, 2008ANDA078212 Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE
Aurobindo Pharma
May 12, 2008ANDA078722 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Sun Pharm Inds Ltd
May 5, 2008ANDA078110 Ropinirole
ROPINIROLE HYDROCHLORIDE
Prinston Inc
April 29, 2008ANDA065435 Penicillin v potassium
PENICILLIN V POTASSIUM
Aurobindo Pharma
April 23, 2008ANDA040866 Primidone
PRIMIDONE
Amneal Pharm
April 17, 2008ANDA078321 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Cspc Ouyi
March 31, 2008ANDA040876 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Kvk Tech
March 31, 2008ANDA040886 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Kvk Tech
March 21, 2008ANDA040875 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Kvk Tech
March 11, 2008ANDA065470 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE
Aurobindo Pharma
March 10, 2008ANDA077763 Clobetasol propionate
CLOBETASOL PROPIONATE
Padagis Israel
February 26, 2008ANDA078155 Simvastatin
SIMVASTATIN
Accord Hlthcare
January 31, 2008ANDA078619 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Aurobindo Pharma
January 31, 2008ANDA078787 Gabapentin
GABAPENTIN
Aurobindo Pharma
January 28, 2008ANDA040762 Phendimetrazine tartrate
PHENDIMETRAZINE TARTRATE
Elite Labs Inc
January 11, 2008ANDA078069 Oxcarbazepine
OXCARBAZEPINE
Breckenridge Pharm
January 8, 2008ANDA077917 Pravastatin sodium
PRAVASTATIN SODIUM
Chartwell Rx
January 8, 2008ANDA078403 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE
Granules
December 28, 2007ANDA077883 Balsalazide disodium
BALSALAZIDE DISODIUM
Apotex
December 17, 2007ANDA078302 Buspirone
BUSPIRONE HYDROCHLORIDE
Oxford Pharms
December 14, 2007ANDA040734 Methimazole
METHIMAZOLE
Heritage Pharma
November 14, 2007ANDA077870 Glyburide and metformin hydrochloride
GLYBURIDE AND METFORMIN HYDROCHLORIDE
Aurobindo Pharma
November 1, 2007ANDA078296 Lovastatin
LOVASTATIN
Lupin
October 31, 2007ANDA078512 Atenolol
ATENOLOL
Aurobindo Pharma
October 30, 2007ANDA078341 Finasteride
FINASTERIDE
Aurobindo Pharma
October 22, 2007ANDA075576 Omeprazole
OMEPRAZOLE
DR Reddys Labs Ltd
October 22, 2007ANDA076048 Omeprazole
OMEPRAZOLE
Apotex
October 17, 2007ANDA078249 Torsemide
TORSEMIDE
Aurobindo Pharma
September 28, 2007ANDA076527 Ofloxacin
OFLOXACIN
Apotex Inc
September 26, 2007ANDA077073 Amlodipine
AMLODIPINE BESYLATE
Cipla
September 21, 2007ANDA040657 Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE
Zydus Pharms USA Inc
September 19, 2007ANDA078164 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Aurobindo Pharma
September 18, 2007ANDA077623 Ciclopirox
CICLOPIROX
Padagis Us
September 18, 2007ANDA077687 Ciclopirox
CICLOPIROX
Encube
September 18, 2007ANDA078172 Ciclopirox
CICLOPIROX
Acella
September 11, 2007ANDA077739 Metoprolol
METOPROLOL TARTRATE
Aurobindo Pharma
September 5, 2007ANDA077614 Carvedilol
CARVEDILOL
Zydus Pharms USA Inc
September 5, 2007ANDA078165 Carvedilol
CARVEDILOL
Rubicon Research
September 5, 2007ANDA078251 Carvedilol
CARVEDILOL
Glenmark Pharms Ltd
September 5, 2007ANDA078332 Carvedilol
CARVEDILOL
Aurobindo Pharma
September 5, 2007ANDA078384 Carvedilol
CARVEDILOL
Regcon Holdings
August 28, 2007ANDA077955 Amlodipine
AMLODIPINE BESYLATE
Invagen Pharms
August 27, 2007ANDA040715 Benztropine mesylate
BENZTROPINE MESYLATE
Ph Health
August 23, 2007ANDA078181 Glimepiride
GLIMEPIRIDE
Accord Hlthcare
August 17, 2007ANDA077903 Zolpidem tartrate
ZOLPIDEM TARTRATE
Torrent Pharms
August 2, 2007ANDA077557 Ondansetron
ONDANSETRON
Sun Pharm Inds
July 31, 2007ANDA078539 Ondansetron
ONDANSETRON HYDROCHLORIDE
Aurobindo Pharma
July 30, 2007ANDA040682 Benzonatate
BENZONATATE
Heritage Pharms Labs
July 30, 2007ANDA078203 Lorazepam
LORAZEPAM
Leading
July 26, 2007ANDA078486 Naproxen
NAPROXEN SODIUM
DR Reddys Labs Ltd
July 25, 2007ANDA040749 Benzonatate
BENZONATATE
Thepharmanetwork LLC
July 25, 2007ANDA078428 Gabapentin
GABAPENTIN
Amneal Pharms Ny
July 12, 2007ANDA078043 Amlodipine
AMLODIPINE BESYLATE
Lupin
July 2, 2007ANDA078163 Terbinafine hydrochloride
TERBINAFINE HYDROCHLORIDE
Orbion Pharms
July 2, 2007ANDA078297 Terbinafine hydrochloride
TERBINAFINE HYDROCHLORIDE
Aurobindo Pharma
June 27, 2007ANDA078152 Ondansetron
ONDANSETRON
Glenmark Pharms Ltd
June 25, 2007ANDA077851 Ondansetron
ONDANSETRON HYDROCHLORIDE
Natco Pharma Ltd
June 18, 2007ANDA078558 Ibuprofen
IBUPROFEN
Amneal Pharms Ny
June 14, 2007ANDA040766 Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE
Ipca Labs Ltd
June 12, 2007ANDA077522 Trandolapril
TRANDOLAPRIL
Lupin
June 12, 2007ANDA078438 Trandolapril
TRANDOLAPRIL
Aurobindo Pharma
June 8, 2007ANDA040597 Benzonatate
BENZONATATE
Zydus Pharms USA
June 8, 2007ANDA077863 Diclofenac
DICLOFENAC SODIUM
Unique
May 29, 2007ANDA065392 Cefadroxil
CEFADROXIL
Lupin
May 11, 2007ANDA078103 Simvastatin
SIMVASTATIN
Lupin
May 2, 2007ANDA077867 Sevoflurane
SOJOURN
Piramal Critical
April 27, 2007ANDA078314 Naproxen
NAPROXEN SODIUM
Glenmark Pharms Ltd
April 26, 2007ANDA077859 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE
Aurobindo Pharma
April 23, 2007ANDA077214 Zolpidem tartrate
ZOLPIDEM TARTRATE
Pharmazone
April 23, 2007ANDA077322 Zolpidem tartrate
ZOLPIDEM TARTRATE
Sandoz
March 30, 2007ANDA040627 Benzonatate
BENZONATATE
Thepharmanetwork LLC
March 30, 2007ANDA040646 Hydrocortisone
HYDROCORTISONE
Impax Labs Inc
March 28, 2007ANDA078250 Naproxen
NAPROXEN
Glenmark Pharms Ltd
March 27, 2007ANDA078216 Citalopram
CITALOPRAM HYDROBROMIDE
Torrent Pharms
March 26, 2007ANDA078012 Gemfibrozil
GEMFIBROZIL
Epic Pharma LLC
March 20, 2007ANDA040786 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Kvk Tech
March 16, 2007ANDA040702 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Leading
March 7, 2007ANDA077584 Paroxetine
PAROXETINE HYDROCHLORIDE
Zydus Pharms USA
February 28, 2007ANDA077797 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Prinston Inc
February 27, 2007ANDA040710 Lidocaine
LIDOCAINE HYDROCHLORIDE
Lannett Co Inc
February 13, 2007ANDA078056 Alprazolam
ALPRAZOLAM
Actavis Elizabeth
February 6, 2007ANDA077206 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE
Aurobindo Pharma
February 6, 2007ANDA077397 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE
Invagen Pharms
February 6, 2007ANDA077670 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE
Lupin
February 1, 2007NDA021777 Cyclobenzaprine hydrochloride
AMRIX
Teva Pharms Intl
January 31, 2007ANDA077712 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE
Strides Pharma Intl
January 25, 2007ANDA065352 Cefadroxil
CEFADROXIL
Aurobindo Pharma
December 27, 2006ANDA077877 Atenolol
ATENOLOL
Ipca Labs Ltd
December 20, 2006ANDA077691 Simvastatin
SIMVASTATIN
Aurobindo Pharma
December 20, 2006ANDA077927 Meloxicam
MELOXICAM
Unichem
December 20, 2006ANDA078034 Simvastatin
SIMVASTATIN
Biocon Pharma
December 15, 2006ANDA077676 Ciclopirox
CICLOPIROX
Padagis Israel
December 7, 2006ANDA077918 Meloxicam
MELOXICAM
Yung Shin Pharm
October 23, 2006ANDA076341 Pravastatin sodium
PRAVASTATIN SODIUM
Apotex
October 16, 2006ANDA077625 Zonisamide
ZONISAMIDE
Zydus Lifesciences
September 27, 2006ANDA077912 Lisinopril and hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Lupin
September 13, 2006ANDA077443 Atenolol
ATENOLOL
Unique
September 12, 2006ANDA077746 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE
Apotex
August 31, 2006ANDA040653 Glycopyrrolate
GLYCOPYRROLATE
Ph Health
August 25, 2006ANDA040736 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Amneal Pharms Ny
August 18, 2006ANDA077662 Gabapentin
GABAPENTIN
Glenmark Pharms Ltd
August 11, 2006ANDA076465 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE
Heritage
August 2, 2006ANDA077361 Trimipramine maleate
TRIMIPRAMINE MALEATE
Elite Labs Inc
July 31, 2006ANDA040712 Promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE
Kvk Tech
July 26, 2006ANDA076756 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Nostrum Pharms LLC
July 20, 2006ANDA077882 Meloxicam
MELOXICAM
Macleods Pharms
July 19, 2006ANDA077921 Meloxicam
MELOXICAM
Zydus Pharms USA
July 19, 2006ANDA077929 Meloxicam
MELOXICAM
Cipla
July 5, 2006ANDA040616 Warfarin sodium
WARFARIN SODIUM
Pliva
June 30, 2006ANDA076934 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE
Strides Pharma
June 28, 2006ANDA077856 Clonazepam
CLONAZEPAM
Prinston Inc
June 20, 2006ANDA077690 Quinapril
QUINAPRIL HYDROCHLORIDE
Lupin
May 31, 2006ANDA077869 Zonisamide
ZONISAMIDE
Invagen Pharms
April 19, 2006ANDA077563 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Jubilant Cadista
March 17, 2006ANDA077634 Zonisamide
ZONISAMIDE
Sun Pharm Inds (In)
March 7, 2006ANDA077414 Desmopressin acetate
DESMOPRESSIN ACETATE
Apotex
March 3, 2006ANDA077364 Ciclopirox
CICLOPIROX
Padagis Israel
February 3, 2006ANDA076820 Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE
Amneal Pharms
January 30, 2006ANDA077651 Zonisamide
ZONISAMIDE
Glenmark Pharms
January 25, 2006ANDA077253 Fluconazole
FLUCONAZOLE
Glenmark Pharms Ltd
January 17, 2006ANDA076143 Bupropion
BUPROPION HYDROCHLORIDE
Apotex
December 20, 2005ANDA077241 Baclofen
BACLOFEN
Lannett Co Inc
December 8, 2005ANDA065285 Doxycycline
DOXYCYCLINE
Lannett Co Inc
December 8, 2005ANDA077376 Mirtazapine
MIRTAZAPINE
Aurobindo Pharma
November 18, 2005ANDA040596 Promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE
Zydus Pharms USA
November 16, 2005ANDA065253 Cephalexin
CEPHALEXIN
Aurobindo Pharma
November 9, 2005ANDA065256 Amoxicillin
AMOXICILLIN
Aurobindo
November 9, 2005ANDA065271 Amoxicillin
AMOXICILLIN
Aurobindo
November 9, 2005ANDA077293 Furosemide
FUROSEMIDE
Leading
October 24, 2005ANDA076686 Dantrolene sodium
DANTROLENE SODIUM
Elite Labs Inc
October 14, 2005ANDA077220 Pilocarpine hydrochloride
PILOCARPINE HYDROCHLORIDE
Lannett Co Inc
October 6, 2005ANDA077091 Glimepiride
GLIMEPIRIDE
DR Reddys Labs Ltd
September 29, 2005ANDA077309 Acyclovir
ACYCLOVIR
Apotex
September 28, 2005ANDA075677 Acyclovir
ACYCLOVIR
Apotex
September 13, 2005ANDA077086 Leflunomide
LEFLUNOMIDE
Heritage
September 9, 2005ANDA077321 Lisinopril
LISINOPRIL
Lupin
August 30, 2005ANDA077068 Baclofen
BACLOFEN
Ph Health
August 26, 2005ANDA077203 Cholestyramine
CHOLESTYRAMINE LIGHT
Ph Health
August 26, 2005ANDA077204 Cholestyramine
CHOLESTYRAMINE
Ph Health
August 25, 2005ANDA065136 Clarithromycin
CLARITHROMYCIN
Sandoz
June 23, 2005NDA020727 Hydralazine hydrochloride and isosorbide dinitrate
BIDIL
Azurity
June 14, 2005ANDA077109 Halobetasol propionate
HALOBETASOL PROPIONATE
Cosette Pharms Nc
May 31, 2005ANDA076894 Torsemide
TORSEMIDE
Heritage
May 13, 2005ANDA065182 Doxycycline
DOXYCYCLINE HYCLATE
Epic Pharma LLC
May 13, 2005ANDA076433 Fenofibrate
FENOFIBRATE
Rhodes Pharms
May 2, 2005ANDA076379 Midazolam
MIDAZOLAM HYDROCHLORIDE
Padagis Us
May 2, 2005ANDA077147 Clonazepam
CLONAZEPAM
Accord Hlthcare
April 21, 2005ANDA077078 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Zydus Lifesciences
April 20, 2005ANDA077222 Fosinopril sodium
FOSINOPRIL SODIUM
Invagen Pharms
April 6, 2005ANDA075360 Gabapentin
GABAPENTIN
Granules
April 6, 2005ANDA077180 Mometasone furoate
MOMETASONE FUROATE
Padagis Israel
April 5, 2005ANDA077066 Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Sandoz
February 24, 2005ANDA040586 Primidone
PRIMIDONE
Oxford Pharms
January 31, 2005ANDA040530 Testosterone cypionate
TESTOSTERONE CYPIONATE
Padagis Us
January 28, 2005ANDA076900 Atenolol
ATENOLOL
Zydus Pharms USA
January 27, 2005ANDA076899 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Amneal Pharms Ny
January 14, 2005ANDA077095 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Aurobindo
December 28, 2004ANDA040604 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Epic Pharma LLC
December 21, 2004ANDA040581 Prednisone
PREDNISONE
Ph Health
December 21, 2004ANDA040584 Prednisone
PREDNISONE
Ph Health
December 21, 2004ANDA076679 Mometasone furoate
MOMETASONE FUROATE
Sun Pharma Canada
December 20, 2004ANDA075317 Terazosin hydrochloride
TERAZOSIN HYDROCHLORIDE
Jubilant Cadista
December 16, 2004ANDA076872 Halobetasol propionate
HALOBETASOL PROPIONATE
Padagis Israel
December 16, 2004ANDA077123 Halobetasol propionate
HALOBETASOL PROPIONATE
Padagis Israel
November 24, 2004ANDA077027 Cilostazol
CILOSTAZOL
Teva
November 5, 2004ANDA077042 Citalopram
CITALOPRAM HYDROBROMIDE
Mylan
October 28, 2004ANDA077031 Citalopram
CITALOPRAM HYDROBROMIDE
Aurobindo
October 22, 2004ANDA076921 Mirtazapine
MIRTAZAPINE
Aurobindo
September 10, 2004ANDA076639 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE
Unique
August 18, 2004ANDA076368 Potassium chloride
POTASSIUM CHLORIDE
Adare Pharms Inc
July 29, 2004ANDA076658 Fluconazole
FLUCONAZOLE
DR Reddys Labs Inc
June 23, 2004ANDA075570 Ammonium lactate
AMMONIUM LACTATE
Padagis Israel
June 23, 2004ANDA076479 Econazole nitrate
ECONAZOLE NITRATE
Padagis Israel
June 10, 2004ANDA076560 Butalbital, acetaminophen, caffeine and codeine phosphate
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
Lgm Pharma
June 9, 2004ANDA076126 Ciprofloxacin
CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE
Carlsbad
June 9, 2004ANDA076558 Ciprofloxacin
CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE
Hikma
May 28, 2004ANDA076408 Metronidazole
METRONIDAZOLE
Fougera Pharms
May 14, 2004ANDA076668 Fluticasone propionate
FLUTICASONE PROPIONATE
Padagis Israel
May 14, 2004ANDA076793 Fluticasone propionate
FLUTICASONE PROPIONATE
Padagis Israel
April 23, 2004ANDA076550 Propafenone hydrochloride
PROPAFENONE HYDROCHLORIDE
Ani Pharms
April 22, 2004ANDA076541 Mirtazapine
MIRTAZAPINE
Sun Pharm Inds Inc
March 26, 2004ANDA076796 Furosemide
FUROSEMIDE
Prinston Inc
February 11, 2004ANDA076118 Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE
Prinston Inc
January 7, 2004ANDA076419 Ketoconazole
KETOCONAZOLE
Padagis Israel
January 6, 2004ANDA065156 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE
Torrent
December 19, 2003ANDA076466 Metolazone
METOLAZONE
Sandoz
December 19, 2003ANDA076732 Metolazone
METOLAZONE
Sandoz
December 9, 2003ANDA076592 Betamethasone dipropionate
BETAMETHASONE DIPROPIONATE
Padagis Israel
November 7, 2003ANDA065123 Mupirocin
MUPIROCIN
Padagis Israel
November 7, 2003ANDA075563 Sotalol hydrochloride
SOTALOL HYDROCHLORIDE
Oxford Pharms
November 5, 2003ANDA076598 Ipratropium bromide
IPRATROPIUM BROMIDE
Hikma
November 5, 2003ANDA076664 Ipratropium bromide
IPRATROPIUM BROMIDE
Hikma
October 23, 2003ANDA040526 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Sun Pharm Industries
September 30, 2003ANDA040537 Cyproheptadine
CYPROHEPTADINE HYDROCHLORIDE
Mountain
September 29, 2003ANDA076416 Tizanidine
TIZANIDINE HYDROCHLORIDE
Sun Pharm Inds Inc
September 16, 2003ANDA076037 Nefazodone hydrochloride
NEFAZODONE HYDROCHLORIDE
Teva
September 12, 2003ANDA075350 Gabapentin
GABAPENTIN
Actavis Elizabeth
September 9, 2003ANDA040480 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Sun Pharm Industries
August 20, 2003ANDA076546 Trimethobenzamide hydrochloride
TRIMETHOBENZAMIDE HYDROCHLORIDE
Lupin
July 1, 2003ANDA076510 Desoximetasone
DESOXIMETASONE
Padagis Israel
June 27, 2003ANDA075798 Allopurinol
ALLOPURINOL
Ph Health
April 21, 2003ANDA076369 Permethrin
PERMETHRIN
Padagis Israel
February 20, 2003ANDA070929 Tamoxifen citrate
TAMOXIFEN CITRATE
Actavis Labs Fl Inc
January 29, 2003ANDA040489 Methocarbamol
METHOCARBAMOL
Oxford Pharms
January 28, 2003ANDA075757 Omeprazole
OMEPRAZOLE
Sandoz
December 4, 2002ANDA075499 Butorphanol tartrate
BUTORPHANOL TARTRATE
Apotex
December 3, 2002ANDA076004 Etodolac
ETODOLAC
Apotex
November 1, 2002ANDA075410 Omeprazole
OMEPRAZOLE
Lannett Co Inc
October 28, 2002ANDA040430 Ethosuximide
ETHOSUXIMIDE
Bionpharma
October 28, 2002ANDA075882 Flecainide acetate
FLECAINIDE ACETATE
Ani Pharms
October 25, 2002ANDA075474 Bisoprolol fumarate
BISOPROLOL FUMARATE
Tp Anda Holdings
October 24, 2002NDA021116 Levothyroxine
THYRO-TABS
Alvogen
September 30, 2002ANDA076102 Lisinopril
LISINOPRIL
Heritage
September 26, 2002ANDA076140 Sotalol hydrochloride
SOTALOL HYDROCHLORIDE
Apotex
August 16, 2002ANDA076070 Nifedipine
NIFEDIPINE
Valeant Pharms North
August 2, 2002ANDA076002 Clotrimazole and betamethasone dipropionate
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Actavis Mid Atlantic
July 26, 2002ANDA076268 Digoxin
DIGOXIN
Stevens J
July 12, 2002ANDA040256 Prednisone
PREDNISONE
Ph Health
July 10, 2002ANDA076095 Misoprostol
MISOPROSTOL
Ani Pharms
July 3, 2002ANDA076286 Tizanidine
TIZANIDINE HYDROCHLORIDE
DR Reddys Labs Inc
July 1, 2002ANDA076059 Lisinopril
LISINOPRIL
Watson Labs
July 1, 2002ANDA076164 Lisinopril
LISINOPRIL
Prinston Inc
July 1, 2002ANDA076194 Lisinopril and hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Watson Labs
July 1, 2002ANDA076230 Lisinopril and hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Prinston Inc
June 25, 2002ANDA075968 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Graviti Pharms
June 14, 2002ANDA040439 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Sandoz
June 5, 2002ANDA075991 Lovastatin
LOVASTATIN
Carlsbad
May 9, 2002ANDA075388 Buspirone
BUSPIRONE HYDROCHLORIDE
Oxford Pharms
May 1, 2002ANDA075774 Ammonium lactate
AMMONIUM LACTATE
Padagis Israel
April 5, 2002ANDA075521 Buspirone
BUSPIRONE HYDROCHLORIDE
Rubicon Research
March 29, 2002ANDA040412 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Prinston Inc
March 22, 2002ANDA076264 Naltrexone hydrochloride
NALTREXONE HYDROCHLORIDE
Specgx LLC
March 18, 2002ANDA076067 Mometasone furoate
MOMETASONE FUROATE
Padagis Us
March 15, 2002ANDA065064 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Sandoz
March 14, 2002ANDA065063 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Sandoz
March 1, 2002NDA021342 Levothyroxine
LEVO-T
Cediprof Inc
February 28, 2002ANDA075022 Buspirone
BUSPIRONE HYDROCHLORIDE
Teva
February 27, 2002ANDA075948 Carbamazepine
CARBAMAZEPINE
Apotex
January 31, 2002ANDA065067 Clindamycin
CLINDAMYCIN PHOSPHATE
Fougera Pharms
January 29, 2002ANDA076001 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Teva Pharms USA
January 10, 2002ANDA075912 Ketoconazole
KETOCONAZOLE
Pharmazone
December 18, 2001ANDA075927 Naproxen
NAPROXEN
Amneal Pharms Ny
December 13, 2001NDA021302 Pimecrolimus
ELIDEL
Bausch
November 30, 2001ANDA075231 Butalbital, aspirin, caffeine and codeine phosphate
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
Lgm Pharma
November 14, 2001ANDA075682 Ibuprofen
IBUPROFEN
DR Reddys
October 12, 2001ANDA075765 Calcitriol
CALCITRIOL
Teva
October 2, 2001NDA021324 Budesonide
ENTOCORT EC
Padagis Us
August 20, 2001ANDA040424 Spironolactone
SPIRONOLACTONE
Mylan
July 5, 2001ANDA075712 Carbamazepine
CARBAMAZEPINE
Torrent Pharms
June 13, 2001ANDA075795 Glipizide
GLIPIZIDE
Apotex
May 31, 2001ANDA040419 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Specgx LLC
May 7, 2001ANDA075902 Fluvoxamine maleate
FLUVOXAMINE MALEATE
Apotex
April 27, 2001ANDA075500 Sotalol hydrochloride
SORINE
Aiping Pharm Inc
April 16, 2001ANDA075718 Famotidine
FAMOTIDINE
DR Reddys Labs Ltd
April 16, 2001ANDA075805 Famotidine
FAMOTIDINE
Carlsbad
March 30, 2001ANDA075424 Amiodarone hydrochloride
AMIODARONE HYDROCHLORIDE
Taro
February 2, 2001ANDA065061 Clindamycin
CLINDAMYCIN HYDROCHLORIDE
Sun Pharm Inds Ltd
January 31, 2001ANDA075855 Oxaprozin
OXAPROZIN
DR Reddys Labs Ltd
January 30, 2001ANDA075614 Terazosin hydrochloride
TERAZOSIN HYDROCHLORIDE
Heritage Pharma Avet
January 23, 2001ANDA075657 Enalapril maleate
ENALAPRIL MALEATE
Taro
December 15, 2000ANDA075379 Valproic acid
VALPROIC ACID
Pharm Assoc
December 4, 2000ANDA075269 Nifedipine
NIFEDIPINE
Valeant Pharms North
December 1, 2000ANDA065055 Doxycycline
DOXYCYCLINE
Strides Pharma Intl
November 30, 2000ANDA065062 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE
Torrent
November 22, 2000ANDA065053 Doxycycline
DOXYCYCLINE
Sun Pharm Inds Ltd
November 16, 2000ANDA075643 Bisoprolol fumarate
BISOPROLOL FUMARATE
Rubicon Research
October 18, 2000ANDA075536 Doxazosin
DOXAZOSIN MESYLATE
Teva
October 18, 2000ANDA075580 Doxazosin
DOXAZOSIN MESYLATE
Apotex
October 6, 2000ANDA075468 Clonazepam
CLONAZEPAM
Rubicon Research
September 27, 2000ANDA075289 Nifedipine
NIFEDIPINE
Valeant Pharms North
July 28, 2000ANDA075667 Terazosin hydrochloride
TERAZOSIN HYDROCHLORIDE
Bionpharma
May 8, 2000ANDA075520 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE
Taro
April 25, 2000ANDA075581 Ketoconazole
KETOCONAZOLE
Teva
April 17, 2000ANDA075491 Bupropion
BUPROPION HYDROCHLORIDE
Aurobindo Pharma USA
April 17, 2000ANDA075522 Isosorbide mononitrate
ISOSORBIDE MONONITRATE
Dexcel Ltd
March 29, 2000ANDA040350 Methimazole
METHIMAZOLE
Mylan
March 14, 2000ANDA075517 Ursodiol
URSODIOL
Epic Pharma
February 11, 2000ANDA075492 Diclofenac
DICLOFENAC SODIUM
Vpna
January 11, 2000NDA020989 Cevimeline hydrochloride
EVOXAC
Cosette
December 23, 1999ANDA075116 Diltiazem
DILTIAZEM HYDROCHLORIDE
Valeant Pharms North
December 20, 1999ANDA074984 Diltiazem
DILTIAZEM HYDROCHLORIDE
Ph Health
September 16, 1999ANDA075126 Etodolac
ETODOLAC
Ani Pharms
September 7, 1999ANDA040317 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Aurobindo Pharma USA
September 7, 1999ANDA040319 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Aurobindo Pharma USA
July 29, 1999ANDA075215 Labetalol
LABETALOL HYDROCHLORIDE
Innogenix
July 15, 1999ANDA040301 Warfarin sodium
WARFARIN SODIUM
Taro
June 25, 1999ANDA040330 Oxycodone and acetaminophen
PERCOCET
Ozantri
June 15, 1999ANDA075319 Ketoconazole
KETOCONAZOLE
Taro
June 9, 1999ANDA075191 Pentoxifylline
PENTOXIFYLLINE
Apotex
May 26, 1999ANDA075274 Naltrexone hydrochloride
NALTREXONE HYDROCHLORIDE
Elite Labs
April 30, 1999ANDA075382 Acyclovir
ACYCLOVIR
Carlsbad
March 19, 1999NDA020612 Lidocaine
LIDODERM
Teikoku Pharma USA
February 26, 1999ANDA040230 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Lannett
January 26, 1999ANDA075090 Acyclovir
ACYCLOVIR
Regcon Holdings
December 31, 1998ANDA040226 Perphenazine
PERPHENAZINE
Ph Health
December 29, 1998ANDA040275 Estradiol
ESTRADIOL
Epic Pharma LLC
December 24, 1998ANDA075264 Tretinoin
TRETINOIN
Padagis Us
December 24, 1998ANDA075265 Tretinoin
TRETINOIN
Padagis Us
December 22, 1998ANDA040183 Methylprednisolone
METHYLPREDNISOLONE
Ph Health
November 30, 1998ANDA075352 Selegiline
SELEGILINE HYDROCHLORIDE
Novitium Pharma
November 20, 1998ANDA074726 Potassium chloride
KLOR-CON M10, KLOR-CON M15, KLOR-CON M20
Upsher Smith Labs
November 20, 1998ANDA075229 Diclofenac
DICLOFENAC POTASSIUM
Rubicon Research
November 13, 1998ANDA075185 Diclofenac
DICLOFENAC SODIUM
Carlsbad
October 5, 1998ANDA075150 Clonazepam
CLONAZEPAM
Aurobindo Pharma USA
August 6, 1998ANDA074943 Diltiazem
DILTIAZEM HYDROCHLORIDE
Apotex
August 6, 1998ANDA075219 Diclofenac
DICLOFENAC POTASSIUM
Teva
July 9, 1998ANDA074752 Diltiazem
CARTIA XT
Actavis Labs Fl Inc
July 7, 1998ANDA074862 Morphine sulfate
MORPHINE SULFATE
Rhodes Pharms
July 2, 1998ANDA074769 Morphine sulfate
MORPHINE SULFATE
Rhodes Pharms
June 19, 1998ANDA040284 Orphenadrine citrate
ORPHENADRINE CITRATE
Lupin
June 8, 1998ANDA074415 Sucralfate
SUCRALFATE
Chartwell Rx
April 30, 1998ANDA075078 Etodolac
ETODOLAC
Taro
April 30, 1998ANDA075135 Amiodarone hydrochloride
PACERONE
Upsher Smith Labs
March 25, 1998ANDA074909 Alprazolam
ALPRAZOLAM
Sandoz
March 11, 1998ANDA075074 Etodolac
ETODOLAC
Taro Pharm Inds
February 27, 1998ANDA040268 Prochlorperazine
PROCOMP
Jubilant Cadista
October 31, 1997ANDA074891 Acyclovir
ACYCLOVIR
Heritage
October 31, 1997ANDA075027 Clobetasol propionate
CLOBETASOL PROPIONATE
Padagis Us
October 22, 1997ANDA040197 Estradiol
ESTRADIOL
Barr Labs Inc
July 8, 1997ANDA074425 Pentoxifylline
PENTOXIFYLLINE
Rising
June 26, 1997ANDA040090 Isoniazid
ISONIAZID
Omnivium Pharms
June 5, 1997ANDA074821 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Sandoz
May 30, 1997ANDA074677 Captopril
CAPTOPRIL
Andas 5 Holding
May 16, 1997ANDA074754 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Teva
March 7, 1997ANDA040188 Carisoprodol
CARISOPRODOL
Oxford Pharms
January 13, 1997ANDA074661 Naproxen
NAPROXEN SODIUM
Perrigo
November 21, 1996ANDA074700 Bumetanide
BUMETANIDE
Sandoz
October 3, 1996ANDA074649 Carbamazepine
CARBAMAZEPINE
Taro
August 16, 1996ANDA064118 Nystatin
NYSTOP
Padagis Us
August 9, 1996ANDA040159 Medroxyprogesterone acetate
MEDROXYPROGESTERONE ACETATE
Barr
July 15, 1996ANDA040156 Hydroxyzine
HYDROXYZINE PAMOATE
Impax Labs Inc
July 3, 1996ANDA064126 Erythromycin
ERYTHROMYCIN
Padagis Us
May 16, 1996ANDA074450 Mexiletine hydrochloride
MEXILETINE HYDROCHLORIDE
Ani Pharms
March 29, 1996ANDA070848 Sucralfate
SUCRALFATE
Teva
January 27, 1996ANDA040150 Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE
Creekwood Pharms
December 13, 1995ANDA072709 Minoxidil
MINOXIDIL
Sun Pharm Industries
November 30, 1995ANDA064050 Clindamycin
CLINDAMYCIN PHOSPHATE
Padagis Us
November 30, 1995ANDA074621 Megestrol acetate
MEGESTROL ACETATE
Barr
September 11, 1995NDA020401 Diltiazem
TIAZAC
Bausch
September 6, 1995NDA019955 Desmopressin acetate
DDAVP
Ferring Pharms Inc
August 31, 1995ANDA074497 Glipizide
GLIPIZIDE
Ani Pharms
July 27, 1995ANDA074299 Indapamide
INDAPAMIDE
Ani Pharms
May 31, 1995ANDA074185 Diltiazem
DILTIAZEM HYDROCHLORIDE
Teva
March 27, 1995ANDA074132 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE
Teva
February 27, 1995ANDA072934 Fluocinonide
FLUOCINONIDE
Fougera Pharms Inc
February 27, 1995ANDA074223 Glipizide
GLIPIZIDE
Watson Labs Teva
January 18, 1995ANDA074056 Atenolol
ATENOLOL
Teva
November 28, 1994ANDA074378 Glipizide
GLIPIZIDE
Oxford Pharms
September 30, 1994ANDA040081 Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE
Teva Pharms
September 30, 1994ANDA064076 Amoxicillin
AMOXICILLIN
Sandoz
May 17, 1994ANDA074151 Cimetidine
CIMETIDINE
Teva
October 31, 1993ANDA074342 Alprazolam
ALPRAZOLAM
Actavis Elizabeth
September 23, 1993ANDA073449 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Watson Labs
June 30, 1993ANDA040001 Methazolamide
METHAZOLAMIDE
Ani Pharms
June 29, 1993ANDA072924 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Watson Labs
June 29, 1993ANDA073484 Valproic acid
VALPROIC ACID
Bionpharma
June 25, 1993ANDA071402 Metoclopramide
METOCLOPRAMIDE HYDROCHLORIDE
Ani Pharms
June 15, 1993ANDA072801 Metoclopramide
METOCLOPRAMIDE HYDROCHLORIDE
Teva
June 15, 1993ANDA074118 Piroxicam
PIROXICAM
Solis Pharms
May 28, 1993ANDA081203 Hydrocortisone
HYDROCORTISONE
Fougera Pharms Inc
January 29, 1993ANDA063211 Erythromycin
ERYTHROMYCIN
Padagis Us
January 29, 1993ANDA081297 Benzonatate
BENZONATATE
Bionpharma
January 28, 1993ANDA073652 Nitrofurantoin
NITROFURANTOIN
Impax Labs Inc
December 7, 1992NDA019892 Hydromorphone hydrochloride
DILAUDID
Rhodes Pharms
May 19, 1992NDA020033 Benazepril hydrochloride and hydrochlorothiazide
LOTENSIN HCT
Validus Pharms
May 15, 1992ANDA081235 Methotrexate
METHOTREXATE SODIUM
Mylan
April 30, 1992ANDA073192 Loperamide hydrochloride
LOPERAMIDE HYDROCHLORIDE
Teva
March 30, 1992ANDA073556 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE
DR Reddys Labs SA
January 24, 1992ANDA072354 Desonide
DESOWEN
Galderma Labs LP
December 30, 1991ANDA063065 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE
Watson Labs
December 30, 1991ANDA063181 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE
Watson Labs Teva
December 27, 1991ANDA062832 Nystatin
NYSTATIN
Sciegen Pharms
September 18, 1991ANDA072741 Loperamide hydrochloride
LOPERAMIDE HYDROCHLORIDE
Mylan
September 17, 1991ANDA073026 Atenolol
ATENOLOL
Pharmobedient
January 11, 1991ANDA063038 Erythromycin
ERYTHROMYCIN
Padagis Us
October 15, 1990ANDA081099 Methotrexate
METHOTREXATE SODIUM
Barr
February 28, 1989ANDA072575 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE
Mylan
December 27, 1988NDA019268 Misoprostol
CYTOTEC
Pfizer
November 30, 1988ANDA071851 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Watson Labs
November 14, 1988ANDA071655 Oxybutynin
OXYBUTYNIN CHLORIDE
Teva Pharms USA
November 14, 1988ANDA071826 Minoxidil
MINOXIDIL
Ph Health
November 14, 1988ANDA071839 Minoxidil
MINOXIDIL
Ph Health
September 30, 1988ANDA089805 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Strides Pharma Intl
September 30, 1988ANDA089828 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Strides Pharma Intl
September 12, 1988ANDA071745 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE
Teva Pharms
August 31, 1988ANDA070886 Clonidine
CLONIDINE HYDROCHLORIDE
Aurobindo Pharma Ltd
August 12, 1988ANDA062752 Tetracycline hydrochloride
TETRACYCLINE HYDROCHLORIDE
Chartwell Tetra
August 8, 1988ANDA072423 Megestrol acetate
MEGESTROL ACETATE
Strides Pharma Intl
May 4, 1988ANDA089853 Chlorzoxazone
CHLORZOXAZONE
Aurobindo Pharma Ltd
May 4, 1988ANDA089859 Chlorzoxazone
CHLORZOXAZONE
Watson Labs
April 6, 1988ANDA071972 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE
Impax Labs Inc
April 5, 1988ANDA071881 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Heritage
January 7, 1988ANDA071173 Haloperidol
HALOPERIDOL
Sciegen Pharms
December 8, 1987ANDA071251 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Apotex Inc
September 4, 1987ANDA070923 Clonidine
CLONIDINE HYDROCHLORIDE
Tp Anda Holdings
August 7, 1987ANDA071620 Temazepam
TEMAZEPAM
Actavis Elizabeth
July 14, 1987ANDA089399 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE
Sun Pharm Inds Inc
July 2, 1987ANDA089534 Spironolactone and hydrochlorothiazide
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Sun Pharm Industries
April 21, 1987ANDA071456 Temazepam
TEMAZEPAM
Novel Labs Inc
April 21, 1987ANDA071457 Temazepam
TEMAZEPAM
Novel Labs Inc
March 3, 1987ANDA071344 Minoxidil
MINOXIDIL
Watson Labs
March 3, 1987ANDA071345 Minoxidil
MINOXIDIL
Watson Labs
February 13, 1987ANDA062702 Cephalexin
CEPHALEXIN
Teva
January 9, 1987ANDA071450 Allopurinol
ALLOPURINOL
Sun Pharm Industries
December 10, 1986ANDA071307 Diazepam
DIAZEPAM
Ivax Sub Teva Pharms
December 10, 1986ANDA071321 Diazepam
DIAZEPAM
Ivax Sub Teva Pharms
December 10, 1986ANDA071322 Diazepam
DIAZEPAM
Ivax Sub Teva Pharms
October 24, 1986ANDA018659 Allopurinol
ALLOPURINOL
Mylan
October 1, 1986ANDA070994 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Watson Labs
October 1, 1986ANDA070995 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Watson Labs
September 17, 1986ANDA070541 Carbamazepine
EPITOL
Teva
August 4, 1986ANDA070322 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE
Innogenix
July 23, 1986ANDA089424 Spironolactone
SPIRONOLACTONE
Sun Pharm Industries
July 21, 1986ANDA089286 Chlorthalidone
CHLORTHALIDONE
Sun Pharm Industries
July 16, 1986ANDA070772 Metronidazole
METRONIDAZOLE
Innogenix
May 13, 1986ANDA070791 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE
Mylan Pharms Inc
April 14, 1986ANDA070221 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE
Ph Health
January 10, 1986ANDA088617 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Pliva
January 10, 1986ANDA088618 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Pliva
January 10, 1986ANDA088619 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Pliva
November 26, 1985ANDA089074 Hydrocortisone
STIE-CORT
Padagis Us
November 6, 1985ANDA062488 Neomycin sulfate, polymyxin b sulfate and hydrocortisone
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Sandoz
September 4, 1985ANDA070325 Diazepam
DIAZEPAM
Mylan
July 29, 1985ANDA070184 Metoclopramide
METOCLOPRAMIDE HYDROCHLORIDE
Teva
December 6, 1984ANDA070027 Metronidazole
METRONIDAZOLE
Teva Pharms USA
December 6, 1984ANDA070033 Metronidazole
METRONIDAZOLE
Pliva
November 9, 1984ANDA088799 Hydrocortisone
HYDROCORTISONE
Taro
November 7, 1984ANDA062396 Doxycycline
DOXYCYCLINE HYCLATE
Hikma
September 28, 1984NDA018877 Allopurinol
ALLOPURINOL
Watson Labs
September 11, 1984ANDA062500 Doxycycline
DOXYCYCLINE HYCLATE
Chartwell
September 11, 1984ANDA062505 Doxycycline
DOXYCYCLINE HYCLATE
Chartwell
June 15, 1984ANDA088488 Hydroxyzine
HYDROXYZINE PAMOATE
Barr Labs
June 15, 1984ANDA088496 Hydroxyzine
HYDROXYZINE PAMOATE
Barr
May 1, 1984ANDA088467 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE
Pliva
March 19, 1984ANDA088042 Triamcinolone acetonide
TRIDERM
Crown Labs
February 13, 1984ANDA062472 Nystatin
NYSTATIN
Padagis Us
December 22, 1983ANDA062474 Nystatin
NYSTATIN
Heritage
December 15, 1983ANDA088481 Dexamethasone
DEXAMETHASONE
Alvogen
September 15, 1983ANDA088316 Dexamethasone
DEXAMETHASONE
Hikma
July 13, 1983ANDA061667 Vancomycin
VANCOCIN HYDROCHLORIDE
Ani Pharms
April 21, 1983ANDA085025 Hydrocortisone
HYDROCORTISONE
Padagis Us
December 20, 1982ANDA087871 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Aurobindo Pharma Ltd
November 18, 1982ANDA087881 Lidocaine
LIDOCAINE HYDROCHLORIDE
Pharmobedient
November 5, 1982NDA018602 Diltiazem
CARDIZEM
Bausch
June 3, 1982ANDA062286 Dicloxacillin sodium
DICLOXACILLIN SODIUM
Chartwell Rx
December 14, 1981ANDA086183 Hydroxyzine
HYDROXYZINE PAMOATE
Sandoz
December 14, 1981ANDA087479 Hydroxyzine
HYDROXYZINE PAMOATE
Sandoz
November 20, 1981ANDA085785 Trifluoperazine hydrochloride
TRIFLUOPERAZINE HYDROCHLORIDE
Sandoz
November 20, 1981ANDA085786 Trifluoperazine hydrochloride
TRIFLUOPERAZINE HYDROCHLORIDE
Sandoz
November 20, 1981ANDA085788 Trifluoperazine hydrochloride
TRIFLUOPERAZINE HYDROCHLORIDE
Sandoz
November 20, 1981ANDA085789 Trifluoperazine hydrochloride
TRIFLUOPERAZINE HYDROCHLORIDE
Sandoz
November 5, 1981ANDA087385 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Padagis Us
October 30, 1981NDA018333 Sucralfate
CARAFATE
Abbvie
April 9, 1981ANDA086413 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Padagis Us
December 11, 1979ANDA062225 Nystatin
NYSTATIN
Padagis Us
October 29, 1979ANDA086727 Diphenoxylate hydrochloride and atropine sulfate
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Ani Pharms
October 29, 1979ANDA086988 Methocarbamol
METHOCARBAMOL
Prinston Inc
October 17, 1978NDA017955 Tretinoin
RETIN-A
Bausch
October 16, 1978ANDA080704 Ergocalciferol
VITAMIN D
Bionpharma
July 19, 1978ANDA084612 Dexamethasone
DEXAMETHASONE
Hikma
March 9, 1978ANDA085691 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Fougera Pharms
November 30, 1977ANDA085027 Hydrocortisone
HYDROCORTISONE
Padagis Us
October 21, 1977ANDA085828 Sulfasalazine
SULFASALAZINE
Watson Labs
August 19, 1977ANDA085588 Phendimetrazine tartrate
PHENDIMETRAZINE TARTRATE
Acertis Pharms
January 7, 1977ANDA085368 Hydrocortisone acetate and pramoxine hydrochloride
PRAMOSONE
Legacy
September 21, 1976ANDA084754 Dexamethasone
DEXAMETHASONE
Pharmazone
July 29, 1976ANDA080966 Probenecid
PROBALAN
Lannett
July 28, 1976ANDA085082 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Watson Labs
June 10, 1976ANDA084768 Chlordiazepoxide hydrochloride
CHLORDIAZEPOXIDE HYDROCHLORIDE
Barr
April 18, 1975NDA017579 Tretinoin
RETIN-A
Valeant Intl
September 30, 1974ANDA084285 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Lannett
January 15, 1974NDA017443 Dantrolene sodium
DANTRIUM
Ph Health
March 9, 1973ANDA080706 Hydrocortisone
ALA-CORT
Crown Labs
August 24, 1972ANDA080936 Isoniazid
ISONIAZID
Genus Lifesciences
August 24, 1972ANDA080937 Isoniazid
ISONIAZID
Genus Lifesciences
April 21, 1972ANDA080352 Prednisone
PREDNISONE
Hikma
July 23, 1971ANDA080154 Propylthiouracil
PROPYLTHIOURACIL
Quagen
August 11, 1961NDA012827 Glycopyrrolate
ROBINUL, ROBINUL FORTE
Casper Pharma LLC
February 14, 1957NDA010721 Meclizine hydrochloride
ANTIVERT
Casper Pharma LLC
—ANDA040600 Hydroxyzine—
—ANDA040602 Hydroxyzine—
—ANDA070924 Clonidine—
—ANDA070925 Clonidine—
—ANDA071586 Allopurinol—
—ANDA074116 Piroxicam—
—ANDA077156 Baclofen—
—ANDA078220 Baclofen—
—ANDA080292 Prednisone—
—ANDA084613 Dexamethasone—
—ANDA086989 Methocarbamol—
—ANDA088306 Dexamethasone—
—ANDA204082 Desvenlafaxine—
—ANDA209727 Prednisone—

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2024

  1. May 10, 2024 · Class III · Ongoing · D-0538-2024 · Cephalexin

    Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'

    Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prep

  2. May 10, 2024 · Class III · Ongoing · D-0540-2024 · Cephalexin

    Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'

    Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepa

  3. May 10, 2024 · Class III · Ongoing · D-0536-2024 · Cephalexin

    Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'

    Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.

  4. May 10, 2024 · Class III · Ongoing · D-0537-2024 · Cephalexin

    Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g

    Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laborat

  5. May 10, 2024 · Class III · Ongoing · D-0539-2024 · Cephalexin

    Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'

    Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch P

2023

  1. April 20, 2023 · Class III · Ongoing · D-0556-2023 · Lidocaine

    Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.

    Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories

2018

  1. July 27, 2018 · Class II · Terminated · D-1029-2018 · Valsartan

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

2016

  1. March 25, 2016 · Class III · Terminated · D-0837-2016 · Venlafaxine hydrochloride

    Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.

    Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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