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Drug company (FDA labeler)

Proficient Rx LP

NDC labeler codes: 63187, 71205, 82804

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

1,579Products (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
January 31, 2025ANDA209404 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Macleods Pharms
September 18, 2024ANDA212931 Bumetanide
BUMETANIDE
Appco
June 11, 2024ANDA218320 Tranexamic acid
TRANEXAMIC ACID
Rubicon Research
January 4, 2024ANDA205504 Eszopiclone
ESZOPICLONE
Hetero Labs Ltd V
December 20, 2023ANDA217669 Famotidine
FAMOTIDINE
Contract Pharmacal
December 14, 2023ANDA217843 Diazepam
DIAZEPAM
Aurobindo Pharma Ltd
October 11, 2023ANDA217738 Naproxen and esomeprazole magnesium
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
Sciegen Pharms
October 3, 2023ANDA214874 Glipizide
GLIPIZIDE
Rubicon Research
September 12, 2023ANDA214344 Atorvastatin
ATORVASTATIN CALCIUM
Hetero Labs Ltd V
September 6, 2023ANDA217334 Estradiol
ESTRADIOL
Novitium Pharma
August 23, 2023ANDA217695 Dexamethasone
DEXAMETHASONE
Apotex
August 17, 2023ANDA217652 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Graviti Pharms
July 11, 2023ANDA217357 Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Mankind Pharma
July 7, 2023ANDA208228 Vilazodone hydrochloride
VILAZODONE HYDROCHLORIDE
Apotex
June 12, 2023ANDA216916 Metoprolol
METOPROLOL SUCCINATE
Granules
April 19, 2023ANDA217001 Dexamethasone
DEXAMETHASONE
Bionpharma
March 21, 2023ANDA217272 Nitrofurantoin
NITROFURANTOIN
Mankind Pharma
March 10, 2023ANDA208045 Lurasidone hydrochloride
LURASIDONE HYDROCHLORIDE
Aurobindo Pharma Ltd
March 10, 2023ANDA216957 Clindamycin
CLINDAMYCIN HYDROCHLORIDE
Glenmark Pharms Ltd
February 23, 2023ANDA216759 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Bionpharma
February 3, 2023ANDA213040 Diclofenac
DICLOFENAC SODIUM
Aurolife Pharma LLC
December 30, 2022ANDA215697 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE
Mankind Pharma
November 23, 2022ANDA215886 Ofloxacin
OFLOXACIN
Mankind Pharma
November 23, 2022ANDA216436 Atorvastatin
ATORVASTATIN CALCIUM
Biocon Pharma
October 6, 2022ANDA213699 Naproxen and esomeprazole magnesium
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
Ajanta Pharma Ltd
September 21, 2022ANDA208021 Diclofenac
DICLOFENAC SODIUM
Lupin Pharms
July 27, 2022ANDA212351 Diclofenac
DICLOFENAC SODIUM
Alembic
July 18, 2022ANDA214475 Fenoprofen calcium
FENOPROFEN CALCIUM
Rising
July 14, 2022ANDA216130 Ofloxacin
OFLOXACIN
Mankind Pharma
July 8, 2022ANDA215723 Isosorbide dinitrate
ISOSORBIDE DINITRATE
Rubicon Research
June 24, 2022ANDA215113 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE
Msn
June 21, 2022ANDA211951 Naloxone hydrochloride
NALOXONE HYDROCHLORIDE
Padagis Israel
May 10, 2022ANDA207588 Levothyroxine
LEVOTHYROXINE SODIUM
Watson Labs Teva
April 1, 2022ANDA215848 Fluphenazine hydrochloride
FLUPHENAZINE HYDROCHLORIDE
Twi Pharms
March 28, 2022ANDA215672 Prednisone
PREDNISONE
Aurobindo Pharma Ltd
March 17, 2022ANDA205237 Lacosamide
LACOSAMIDE
Sciegen Pharms
March 8, 2022ANDA212988 Pregabalin
PREGABALIN
Pharmazone
February 2, 2022ANDA215568 Bupropion
BUPROPION HYDROCHLORIDE
Granules
January 18, 2022ANDA209920 Lubiprostone
LUBIPROSTONE
Teva Pharms USA Inc
January 11, 2022ANDA215939 Oxcarbazepine
OXCARBAZEPINE
Annora Pharma
December 8, 2021ANDA213949 Lamotrigine
LAMOTRIGINE
Pharmobedient
December 3, 2021ANDA213320 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Harman Finochem
October 25, 2021ANDA207842 Eplerenone
EPLERENONE
Everest Lifesciences
October 7, 2021ANDA201806 Emtricitabine and tenofovir disoproxil fumarate
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Hetero Labs Ltd III
October 1, 2021ANDA214957 Gabapentin
GABAPENTIN
Ascent Pharms Inc
June 25, 2021ANDA211935 Nitrofurantoin
NITROFURANTOIN
Alembic
June 1, 2021ANDA207085 Albuterol sulfate
ALBUTEROL SULFATE
Sandoz
May 20, 2021ANDA212443 Ketoconazole
KETOCONAZOLE
Encube
May 19, 2021ANDA214548 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE
Unichem
May 7, 2021ANDA214092 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA
Sciegen Pharms
March 19, 2021ANDA213486 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Graviti Pharms
February 26, 2021ANDA210559 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Indchemie Health
February 19, 2021ANDA210220 Cefdinir
CEFDINIR
Alkem Labs Ltd
February 11, 2021ANDA208412 Prednisone
PREDNISONE
Strides Pharma
January 26, 2021ANDA214492 Zonisamide
ZONISAMIDE
Unichem
January 13, 2021ANDA214603 Gemfibrozil
GEMFIBROZIL
Ascent Pharms Inc
December 10, 2020ANDA212977 Omeprazole
OMEPRAZOLE
Xiromed
December 3, 2020ANDA205129 Celecoxib
CELECOXIB
Sciegen Pharms
December 2, 2020ANDA211735 Penicillamine
PENICILLAMINE
Granules
November 27, 2020ANDA205130 Levetiracetam
LEVETIRACETAM
Sciegen Pharms
November 25, 2020ANDA211143 Metoprolol
METOPROLOL SUCCINATE
Alkem Labs Ltd
November 6, 2020ANDA205541 Metoprolol
METOPROLOL SUCCINATE
Hetero Labs Ltd III
November 3, 2020ANDA203825 Nebivolol
NEBIVOLOL HYDROCHLORIDE
Hetero Labs Ltd III
October 23, 2020ANDA211298 Tadalafil
TADALAFIL
Umedica
October 22, 2020ANDA213929 Leucovorin calcium
LEUCOVORIN CALCIUM
Leading
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 15, 2020ANDA214284 Amantadine
AMANTADINE HYDROCHLORIDE
Alembic
October 1, 2020ANDA207849 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE
Xiromed
August 28, 2020ANDA212982 Clobetasol propionate
CLOBETASOL PROPIONATE
Encube
August 25, 2020ANDA209302 Sildenafil
SILDENAFIL CITRATE
Umedica
August 24, 2020ANDA209954 Albuterol sulfate
ALBUTEROL SULFATE
Lupin
August 21, 2020ANDA213186 Ramelteon
RAMELTEON
Granules
August 19, 2020ANDA213853 Atorvastatin
ATORVASTATIN CALCIUM
Umedica
June 24, 2020ANDA213386 Prednisone
PREDNISONE
Amneal
June 19, 2020ANDA211832 Terbutaline sulfate
TERBUTALINE SULFATE
Twi Pharms
June 12, 2020ANDA213864 Fenofibrate
FENOFIBRATE
Mankind Pharma
May 21, 2020ANDA212044 Amantadine
AMANTADINE HYDROCHLORIDE
Rubicon Research
May 20, 2020ANDA212544 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Msn
May 8, 2020ANDA213794 Ibuprofen
IBUPROFEN
Aurobindo Pharma Ltd
April 23, 2020ANDA213185 Trospium chloride
TROSPIUM CHLORIDE
Granules
April 10, 2020ANDA212650 Ramelteon
RAMELTEON
Pharmazone
March 18, 2020ANDA209553 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE
Yiling
March 2, 2020ANDA207178 Sildenafil
SILDENAFIL CITRATE
Appco
February 24, 2020ANDA203760 Albuterol sulfate
ALBUTEROL SULFATE
Padagis Us
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 11, 2020ANDA213412 Chlorthalidone
CHLORTHALIDONE
Alkem Labs Ltd
February 7, 2020ANDA211364 Clomipramine hydrochloride
CLOMIPRAMINE HYDROCHLORIDE
Leading
January 27, 2020ANDA210986 Diclofenac
DICLOFENAC SODIUM
Encube
January 24, 2020ANDA213343 Methotrexate
METHOTREXATE SODIUM
Accord Hlthcare
December 12, 2019ANDA212019 Bumetanide
BUMETANIDE
Rising
November 15, 2019ANDA211575 Prednisone
PREDNISONE
Novitium Pharma
November 14, 2019ANDA210907 Buspirone
BUSPIRONE HYDROCHLORIDE
Unichem
October 30, 2019ANDA212199 Naproxen
NAPROXEN SODIUM
Sciegen Pharms
October 9, 2019ANDA211343 Doxycycline
DOXYCYCLINE HYCLATE
Changzhou Pharm
October 8, 2019ANDA206912 Pregabalin
PREGABALIN
Hetero Labs Ltd III
October 7, 2019ANDA209402 Doxycycline
DOXYCYCLINE HYCLATE
Changzhou Pharm
September 13, 2019ANDA212624 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE
Ajanta Pharma Ltd
September 10, 2019ANDA212418 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Elite Labs Inc
September 6, 2019ANDA209876 Colchicine
COLCHICINE
DR Reddys
August 27, 2019ANDA211701 Solifenacin succinate
SOLIFENACIN SUCCINATE
Unichem
July 24, 2019ANDA212557 Nystatin
NYSTATIN
Torrent
July 19, 2019ANDA207799 Pregabalin
PREGABALIN
Alkem Labs Ltd
July 19, 2019ANDA208677 Pregabalin
PREGABALIN
Sciegen Pharms
July 19, 2019ANDA209357 Pregabalin
PREGABALIN
Msn
July 19, 2019ANDA209743 Pregabalin
PREGABALIN
Amneal Pharms Co
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 4, 2019ANDA211829 Ranolazine
RANOLAZINE
Sciegen Pharms
May 20, 2019ANDA202551 Solifenacin succinate
SOLIFENACIN SUCCINATE
Watson Labs Inc
May 20, 2019ANDA209333 Solifenacin succinate
SOLIFENACIN SUCCINATE
Qilu
May 20, 2019ANDA210224 Solifenacin succinate
SOLIFENACIN SUCCINATE
Alkem Labs Ltd
April 30, 2019ANDA211604 Nitroglycerin
NITROGLYCERIN
Natco
April 29, 2019ANDA204800 Felodipine
FELODIPINE
Yung Shin Pharm
April 17, 2019ANDA208250 Azithromycin
AZITHROMYCIN
Cspc Ouyi
April 2, 2019ANDA206803 Selegiline
SELEGILINE HYDROCHLORIDE
Rising
March 27, 2019ANDA211603 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE
Aurobindo Pharma Ltd
March 26, 2019ANDA209167 Tadalafil
TADALAFIL
Accord Hlthcare
March 26, 2019ANDA209250 Tadalafil
TADALAFIL
Unichem
March 26, 2019ANDA209654 Tadalafil
TADALAFIL
Ajanta Pharma Ltd
March 8, 2019ANDA211064 Folic acid
FOLIC ACID
Rising
March 1, 2019ANDA205056 Perphenazine
PERPHENAZINE
Rising
February 26, 2019ANDA210000 Azithromycin
AZITHROMYCIN
Bionpharma
February 26, 2019ANDA210001 Azithromycin
AZITHROMYCIN
Bionpharma
February 22, 2019ANDA211518 Benzonatate
BENZONATATE
Ascent Pharms Inc
February 11, 2019ANDA208358 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Cadila
February 8, 2019ANDA211933 Atorvastatin
ATORVASTATIN CALCIUM
Msn
January 18, 2019ANDA209713 Levothyroxine
LEVOTHYROXINE SODIUM
Lupin
January 14, 2019ANDA203561 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Sciegen Pharms
December 21, 2018ANDA209288 Atorvastatin
ATORVASTATIN CALCIUM
Alkem Labs Ltd
December 19, 2018ANDA206948 Benzonatate
BENZONATATE
Puracap Pharm LLC
December 19, 2018ANDA207206 Metoprolol
METOPROLOL SUCCINATE
Visum Pharm
December 11, 2018ANDA210958 Lidocaine
LIDOCAINE
Strides Pharma
December 7, 2018ANDA204276 Ergocalciferol
ERGOCALCIFEROL
Puracap Pharm LLC
November 23, 2018ANDA209828 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Macleods Pharms
November 23, 2018ANDA211469 Lidocaine
LIDOCAINE
Alembic
November 9, 2018ANDA206037 Anastrozole
ANASTROZOLE
Pharmobedient
November 7, 2018ANDA211487 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Ascent Pharms Inc
November 5, 2018ANDA207402 Clindamycin
CLINDAMYCIN HYDROCHLORIDE
Micro Labs
October 31, 2018ANDA209587 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Lgm Pharma
October 31, 2018ANDA210497 Bupropion
BUPROPION HYDROCHLORIDE
Accord Hlthcare
October 25, 2018ANDA208249 Azithromycin
AZITHROMYCIN
Cspc Ouyi
October 22, 2018ANDA206145 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Alkem Labs Ltd
October 12, 2018ANDA206401 Sildenafil
SILDENAFIL CITRATE
Ajanta Pharma Ltd
October 5, 2018ANDA209852 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Teva Pharms USA
July 31, 2018ANDA211147 Azithromycin
AZITHROMYCIN
Zydus Lifesciences
July 27, 2018ANDA210893 Diclofenac
DICLOFENAC SODIUM
Padagis Israel
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 22, 2018ANDA208921 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE
Pharmobedient
June 22, 2018ANDA209314 Potassium chloride
POTASSIUM CHLORIDE
Yichang Humanwell
June 20, 2018ANDA209603 Labetalol
LABETALOL HYDROCHLORIDE
Appco
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 11, 2018ANDA203962 Sildenafil
SILDENAFIL CITRATE
Aurobindo Pharma Ltd
June 8, 2018ANDA209421 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Strides Pharma
May 31, 2018ANDA207774 Doxycycline
DOXYCYCLINE HYCLATE
Zydus Lifesciences
May 24, 2018ANDA207222 Chlorthalidone
CHLORTHALIDONE
Umedica
May 24, 2018ANDA208516 Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Sunny
May 18, 2018ANDA209535 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Macleods Pharms
May 14, 2018ANDA204072 Methylprednisolone
METHYLPREDNISOLONE
Tianjin Tianyao
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
April 30, 2018ANDA204776 Celecoxib
CELECOXIB
Micro Labs
April 24, 2018ANDA208644 Rabeprazole sodium
RABEPRAZOLE SODIUM
Alkem Labs Ltd
April 23, 2018ANDA206751 Methylprednisolone
METHYLPREDNISOLONE
Zydus Pharms
April 9, 2018ANDA207531 Azithromycin
AZITHROMYCIN
Epic Pharma LLC
March 30, 2018ANDA207687 Atorvastatin
ATORVASTATIN CALCIUM
Accord Hlthcare
March 23, 2018ANDA203894 Metoprolol
METOPROLOL SUCCINATE
Zydus Pharms
March 20, 2018ANDA200959 Sevelamer carbonate
SEVELAMER CARBONATE
Quagen
March 16, 2018ANDA209313 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Granules
March 7, 2018ANDA210401 Acyclovir
ACYCLOVIR
Pharmobedient
February 23, 2018ANDA209438 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Hetero Labs Ltd III
February 20, 2018ANDA208347 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Lupin
February 6, 2018ANDA204106 Metoprolol
METOPROLOL SUCCINATE
Novast Labs
January 26, 2018ANDA090513 Emtricitabine and tenofovir disoproxil fumarate
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Aurobindo Pharma
January 23, 2018ANDA210071 Celecoxib
CELECOXIB
Cspc Ouyi
January 12, 2018ANDA209688 Potassium chloride
POTASSIUM CHLORIDE
Twi Pharms
January 9, 2018ANDA208348 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Lupin
December 29, 2017ANDA206152 Piroxicam
PIROXICAM
Micro Labs
December 22, 2017ANDA203572 Lorazepam
LORAZEPAM
Aurobindo Pharma
December 21, 2017ANDA209234 Ezetimibe
EZETIMIBE
Alkem Labs Ltd
December 19, 2017ANDA207803 Fenofibrate
FENOFIBRATE
Bostal
November 28, 2017ANDA209102 Baclofen
BACLOFEN
Rubicon Research
November 22, 2017ANDA208898 Rosuvastatin
ROSUVASTATIN CALCIUM
Msn
November 20, 2017ANDA209734 Acetazolamide
ACETAZOLAMIDE
Strides Pharma
November 6, 2017ANDA204901 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Prinston Inc
October 26, 2017ANDA207057 Gabapentin
GABAPENTIN
Cspc Ouyi
October 20, 2017ANDA205229 Progesterone
PROGESTERONE
Xiromed
October 10, 2017ANDA205253 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE
Zydus Pharms
October 6, 2017ANDA209114 Nystatin
NYSTATIN
Cosette
October 4, 2017ANDA206242 Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE
Eugia Pharma
September 28, 2017ANDA209582 Doxycycline
DOXYCYCLINE
Zydus Pharms
September 19, 2017ANDA206391 Nitroglycerin
NITROGLYCERIN
Glenmark Speclt
September 18, 2017ANDA208848 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Encube
September 14, 2017ANDA207211 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Macleods Pharms
September 14, 2017ANDA209966 Modafinil
MODAFINIL
Cadila
September 8, 2017ANDA206923 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE
Accord Hlthcare
August 31, 2017ANDA207466 Metaxalone
METAXALONE
Sciegen Pharms
August 25, 2017ANDA209838 Ezetimibe
EZETIMIBE
Aurobindo Pharma
August 16, 2017ANDA206261 Acyclovir
ACYCLOVIR
Carlsbad
August 11, 2017ANDA207405 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE
Alkem Labs Ltd
August 7, 2017ANDA207875 Ipratropium bromide and albuterol sulfate
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
Sun Pharm
July 28, 2017ANDA209165 Doxycycline
DOXYCYCLINE
Alembic
July 21, 2017ANDA207857 Albuterol sulfate
ALBUTEROL SULFATE
Sun Pharm
July 21, 2017ANDA208507 Methocarbamol
METHOCARBAMOL
Regcon Holdings
July 17, 2017ANDA201270 Dexamethasone
DEXAMETHASONE
Pharmobedient
June 30, 2017ANDA207224 Bupropion
BUPROPION HYDROCHLORIDE
Anbison Lab
June 28, 2017ANDA207444 Tobramycin
TOBRAMYCIN
Somerset Theraps LLC
June 20, 2017ANDA206136 Piroxicam
PIROXICAM
Strides Pharma
June 15, 2017ANDA203695 Metaxalone
METAXALONE
Actavis Labs Fl Inc
June 12, 2017ANDA203931 Ezetimibe
EZETIMIBE
Sandoz
June 7, 2017ANDA209047 Amantadine
AMANTADINE HYDROCHLORIDE
Strides Pharma
May 31, 2017ANDA208170 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Rubicon Research
May 5, 2017ANDA206173 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Cadila Pharms Ltd
April 24, 2017ANDA204798 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL
Aurobindo Pharma
April 24, 2017ANDA206763 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL
Alkem Labs Ltd
March 27, 2017ANDA205300 Atorvastatin
ATORVASTATIN CALCIUM
Teva Pharms USA
March 24, 2017ANDA207099 Gabapentin
GABAPENTIN
Rising
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 10, 2017ANDA207810 Lidocaine
LIDOCAINE
Alkem Labs Ltd
March 7, 2017ANDA207835 Rizatriptan benzoate
RIZATRIPTAN BENZOATE
Unichem
March 3, 2017ANDA208590 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Encube
February 16, 2017ANDA208963 Fluconazole
FLUCONAZOLE
Zydus Pharms
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
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 6, 2016ANDA207476 Omeprazole and sodium bicarbonate
OMEPRAZOLE AND SODIUM BICARBONATE
Sciegen Pharms
November 25, 2016ANDA204161 Metoprolol
METOPROLOL SUCCINATE
Actavis Elizabeth
November 23, 2016ANDA202413 Ibuprofen
IBUPROFEN
Shandong Xinhua
November 22, 2016ANDA204770 Metaxalone
METAXALONE
Lannett Co Inc
November 17, 2016ANDA207068 Pravastatin sodium
PRAVASTATIN SODIUM
Accord Hlthcare
November 1, 2016ANDA204216 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Gland
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 21, 2016ANDA206574 Dutasteride
DUTASTERIDE
Ascent Pharms Inc
September 20, 2016ANDA203375 Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Acella
September 19, 2016ANDA203512 Spironolactone
SPIRONOLACTONE
Accord Hlthcare
September 16, 2016ANDA202696 Valsartan
VALSARTAN
Macleods Pharms Ltd
September 15, 2016ANDA205823 Quinapril
QUINAPRIL HYDROCHLORIDE
Prinston Inc
September 15, 2016ANDA208451 Eszopiclone
ESZOPICLONE
Aurobindo Pharma
September 13, 2016ANDA208301 Diclofenac
DICLOFENAC SODIUM
Glenmark Pharms Ltd
September 9, 2016ANDA206498 Lidocaine
LIDOCAINE
Glenmark Pharms Ltd
September 2, 2016ANDA206116 Diclofenac
DICLOFENAC SODIUM
Amneal Pharms
August 26, 2016ANDA206556 Bupropion
BUPROPION HYDROCHLORIDE
Invagen Pharms
August 26, 2016ANDA208191 Nitroglycerin
NITROGLYCERIN
DR Reddys
August 23, 2016ANDA203824 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Hikma Pharms
July 19, 2016ANDA079170 Rosuvastatin
ROSUVASTATIN CALCIUM
Aurobindo Pharma Ltd
July 19, 2016ANDA079172 Rosuvastatin
ROSUVASTATIN CALCIUM
Glenmark Speclt
June 29, 2016ANDA203702 Ceftriaxone sodium
CEFTRIAXONE
Qilu Antibiotics
June 27, 2016ANDA207289 Doxycycline
DOXYCYCLINE HYCLATE
Amneal Pharms
June 20, 2016ANDA204883 Sildenafil
SILDENAFIL CITRATE
Rubicon Research
June 17, 2016ANDA204838 Aripiprazole
ARIPIPRAZOLE
Amneal Pharms
June 15, 2016ANDA202935 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Strides Pharma Intl
May 31, 2016ANDA208278 Amantadine
AMANTADINE HYDROCHLORIDE
Zydus Pharms
May 27, 2016ANDA206121 Oxybutynin
OXYBUTYNIN CHLORIDE
Unique
May 19, 2016ANDA205519 Atorvastatin
ATORVASTATIN CALCIUM
Sciegen Pharms
April 29, 2016ANDA090295 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Pharmazone
April 28, 2016ANDA206298 Diclofenac
DICLOFENAC SODIUM
Sun Pharma Canada
March 25, 2016ANDA204313 Acyclovir
ACYCLOVIR
Cadila
March 16, 2016ANDA204590 Celecoxib
CELECOXIB
Macleods Pharms
March 9, 2016ANDA077342 Sildenafil
SILDENAFIL CITRATE
Teva
March 1, 2016ANDA205794 Bupropion
BUPROPION HYDROCHLORIDE
Sciegen Pharms
February 29, 2016ANDA207138 Oxybutynin
OXYBUTYNIN CHLORIDE
Accord Hlthcare
February 18, 2016ANDA204989 Gabapentin
RELGAABI
Sciegen Pharms
February 18, 2016ANDA205115 Doxycycline
DOXYCYCLINE
Zydus Pharms
February 16, 2016ANDA201722 Nitrofurantoin
NITROFURANTOIN
Sun Pharm Industries
February 4, 2016ANDA205101 Gabapentin
GABAPENTIN
Sciegen Pharms
February 1, 2016ANDA205318 Lidocaine
LIDOCAINE
Encube
January 26, 2016ANDA205119 Pantoprazole sodium
PANTOPRAZOLE SODIUM
Amneal Pharms
January 13, 2016ANDA205415 Pindolol
PINDOLOL
Mpp Pharma
December 28, 2015ANDA203661 Cefazolin
CEFAZOLIN SODIUM
Qilu Antibiotics
December 22, 2015ANDA206530 Famotidine
FAMOTIDINE
Aurobindo Pharma Ltd
December 2, 2015ANDA206493 Diclofenac
DICLOFENAC SODIUM
Actavis Mid Atlantic
November 20, 2015ANDA203118 Dutasteride
DUTASTERIDE
Amneal Pharms
November 18, 2015ANDA204237 Rabeprazole sodium
RABEPRAZOLE SODIUM
Rubicon Research
November 18, 2015NDA208411 Naloxone hydrochloride
NARCAN
Emergent
October 30, 2015ANDA202894 Clotrimazole and betamethasone dipropionate
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Glenmark Speclt
October 30, 2015ANDA205150 Telmisartan
TELMISARTAN
Adaptis
October 26, 2015ANDA203179 Calcium acetate
CALCIUM ACETATE
Mpp Pharma
October 8, 2015ANDA203908 Aripiprazole
ARIPIPRAZOLE
Aurobindo Pharma
October 8, 2015ANDA204290 Montelukast
MONTELUKAST SODIUM
Unichem
September 28, 2015ANDA203584 Clarithromycin
CLARITHROMYCIN
Hec Pharm
September 25, 2015ANDA078279 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
DR Reddys
September 23, 2015ANDA207446 Celecoxib
CELECOXIB
Cipla
September 15, 2015ANDA091625 Ibuprofen
IBUPROFEN
Granules
September 4, 2015ANDA205082 Desoximetasone
DESOXIMETASONE
Actavis Mid Atlantic
August 28, 2015ANDA078032 Escitalopram
ESCITALOPRAM OXALATE
Prinston Inc
August 26, 2015ANDA203197 Duloxetine
DULOXETINE HYDROCHLORIDE
Alkem Labs Ltd
August 21, 2015ANDA204519 Celecoxib
CELECOXIB
Alembic
August 20, 2015ANDA204132 Diclofenac
DICLOFENAC SODIUM
Lupin
August 19, 2015ANDA203270 Omeprazole
OMEPRAZOLE
Aurobindo Pharma
August 12, 2015ANDA203835 Losartan potassium
LOSARTAN POTASSIUM
Hetero Labs Ltd V
July 31, 2015ANDA202765 Benzonatate
BENZONATATE
Cspc-Nbp Pharm
July 31, 2015ANDA203328 Montelukast
MONTELUKAST SODIUM
Ajanta Pharma Ltd
July 31, 2015ANDA203346 Alprazolam
ALPRAZOLAM
Aurobindo Pharma
July 31, 2015ANDA203432 Montelukast
MONTELUKAST SODIUM
Ajanta Pharma Ltd
July 8, 2015ANDA202769 Diclofenac
DICLOFENAC SODIUM
Pai Holdings Pharm
June 29, 2015ANDA204003 Desvenlafaxine
DESVENLAFAXINE SUCCINATE
Alembic
June 26, 2015ANDA078560 Ezetimibe
EZETIMIBE
Glenmark Pharms Ltd
June 9, 2015ANDA204821 Valsartan
VALSARTAN
Prinston Inc
June 2, 2015ANDA201408 Guanfacine
GUANFACINE HYDROCHLORIDE
Twi Pharms
June 2, 2015ANDA204197 Celecoxib
CELECOXIB
Apotex
May 26, 2015ANDA202304 Bupropion
BUPROPION HYDROCHLORIDE
Prinston Inc
May 15, 2015ANDA065398 Azithromycin
AZITHROMYCIN
Lupin
April 28, 2015ANDA201519 Aripiprazole
ARIPIPRAZOLE
Torrent
April 8, 2015ANDA203047 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE
Hetero Labs Ltd V
March 16, 2015ANDA204597 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Sciegen Pharms
February 24, 2015ANDA203965 Miglitol
MIGLITOL
Orient Pharma
February 23, 2015ANDA077006 Tolterodine tartrate
TOLTERODINE TARTRATE
Ivax Sub Teva Pharms
February 11, 2015ANDA200562 Celecoxib
CELECOXIB
Watson Labs Inc
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 5, 2014ANDA205019 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Nuvo Pharm
November 26, 2014ANDA203623 Sildenafil
SILDENAFIL CITRATE
Hetero Labs Ltd V
November 26, 2014ANDA203818 Diclofenac
DICLOFENAC SODIUM
Sun Pharma Canada
November 26, 2014ANDA204785 Acetaminophen, caffeine, dihydrocodeine bitartrate
TREZIX
Key Therap
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 30, 2014ANDA203037 Montelukast
MONTELUKAST SODIUM
Pharmobedient
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 15, 2014ANDA204030 Amoxicillin
AMOXICILLIN
Aurobindo Pharma Ltd
September 15, 2014ANDA204165 Clopidogrel
CLOPIDOGREL BISULFATE
Sciegen Pharms
September 10, 2014ANDA202438 Famciclovir
FAMCICLOVIR
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 27, 2014ANDA203139 Megestrol acetate
MEGESTROL ACETATE
Twi Pharms
August 25, 2014ANDA202330 Buspirone
BUSPIRONE HYDROCHLORIDE
Strides Pharma
August 20, 2014ANDA204279 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Heritage
August 19, 2014ANDA204314 Acyclovir
ACYCLOVIR
Zydus Pharms
August 15, 2014ANDA202862 Olanzapine
OLANZAPINE
Macleods Pharms Ltd
August 6, 2014ANDA203068 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Aurobindo Pharma Ltd
July 15, 2014ANDA205292 Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Padagis Us
June 11, 2014ANDA202824 Doxazosin
DOXAZOSIN MESYLATE
Accord Hlthcare
June 11, 2014ANDA203088 Duloxetine
DULOXETINE HYDROCHLORIDE
Breckenridge
June 10, 2014ANDA090877 Risedronate
RISEDRONATE SODIUM
Apotex
June 4, 2014ANDA202446 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE
Accord Hlthcare
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 31, 2014ANDA203494 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Aurobindo Pharma Ltd
March 5, 2014ANDA204234 Doxycycline
DOXYCYCLINE
Lupin
January 27, 2014ANDA203374 Carisoprodol
CARISOPRODOL
Sciegen Pharms
January 23, 2014ANDA091134 Etodolac
ETODOLAC
Zydus Pharms
January 22, 2014ANDA203458 Metronidazole
METRONIDAZOLE
Unichem
January 17, 2014ANDA201567 Bupropion
BUPROPION HYDROCHLORIDE
Zydus Pharms
December 23, 2013ANDA203370 Lamotrigine
LAMOTRIGINE
Torrent
December 17, 2013ANDA090776 Duloxetine
DULOXETINE HYDROCHLORIDE
Actavis Elizabeth
December 17, 2013ANDA203814 Sildenafil
SILDENAFIL CITRATE
Macleods Pharms
December 11, 2013ANDA090778 Duloxetine
DULOXETINE HYDROCHLORIDE
Aurobindo Pharma Ltd
November 27, 2013ANDA202180 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE
Torrent
November 8, 2013ANDA090678 Rabeprazole sodium
RABEPRAZOLE SODIUM
Lannett Co Inc
November 8, 2013ANDA202376 Rabeprazole sodium
RABEPRAZOLE SODIUM
Torrent
November 5, 2013ANDA091643 Finasteride
FINASTERIDE
Accord Hlthcare
October 29, 2013ANDA203834 Acyclovir
ACYCLOVIR
Hetero Labs Ltd V
October 21, 2013ANDA203245 Amlodipine
AMLODIPINE BESYLATE
Unichem
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 16, 2013ANDA200900 Progesterone
PROGESTERONE
Bionpharma
July 15, 2013ANDA201972 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN
Aurolife Pharma LLC
July 12, 2013ANDA203244 Gabapentin
GABAPENTIN
Strides Pharma
July 1, 2013ANDA203062 Rizatriptan benzoate
RIZATRIPTAN BENZOATE
Aurobindo Pharma Ltd
June 21, 2013ANDA203399 Metaxalone
METAXALONE
Amneal Pharms
June 3, 2013ANDA201507 Hydroxyzine
HYDROXYZINE PAMOATE
Heritage Pharma
May 28, 2013ANDA202871 Metoprolol
METOPROLOL TARTRATE
Alembic Pharms Ltd
May 13, 2013ANDA090867 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE
Sun Pharm Inds Inc
May 6, 2013ANDA203154 Allopurinol
ALLOPURINOL
Accord Hlthcare
May 3, 2013ANDA200770 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE
Strides Pharma
April 30, 2013ANDA202433 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE
Aurobindo Pharma Ltd
April 29, 2013ANDA202725 Quinapril
QUINAPRIL HYDROCHLORIDE
Aurobindo Pharma Ltd
April 26, 2013ANDA090297 Levalbuterol
LEVALBUTEROL HYDROCHLORIDE
Teva Pharms USA
April 19, 2013ANDA203145 Valsartan and hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE
Macleods Pharms Ltd
April 15, 2013ANDA202800 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Aurolife Pharma LLC
March 21, 2013ANDA078946 Valsartan and hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE
Lupin Ltd
March 21, 2013ANDA201662 Valsartan and hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE
Alembic
March 21, 2013ANDA202519 Valsartan and hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE
Aurobindo Pharma Ltd
February 28, 2013ANDA202025 Sildenafil
SILDENAFIL CITRATE
Amneal Pharms
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 7, 2013ANDA078380 Sildenafil
SILDENAFIL CITRATE
Teva Pharms
December 31, 2012ANDA202490 Rizatriptan benzoate
RIZATRIPTAN BENZOATE
Aurobindo Pharma Ltd
December 28, 2012NDA202155 Apixaban
ELIQUIS
Bristol Myers Squibb
November 29, 2012ANDA200295 Liothyronine sodium
LIOTHYRONINE SODIUM
Sigmapharm Labs LLC
November 28, 2012ANDA090168 Benztropine mesylate
BENZTROPINE MESYLATE
Leading
November 28, 2012ANDA091283 Tizanidine
TIZANIDINE HYDROCHLORIDE
Unichem Labs Ltd
November 6, 2012ANDA091479 Sildenafil
SILDENAFIL CITRATE
Torrent Pharms Ltd
October 24, 2012ANDA040903 Imipramine
IMIPRAMINE HYDROCHLORIDE
Leading
October 16, 2012ANDA202764 Gabapentin
GABAPENTIN
Invagen Pharms
October 3, 2012ANDA202254 Irbesartan
IRBESARTAN
Macleods Pharms Ltd
September 28, 2012ANDA201807 Indomethacin
INDOMETHACIN
Hetero Labs Ltd III
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, 2012ANDA202556 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Accord Hlthcare
September 21, 2012ANDA202717 Montelukast
MONTELUKAST SODIUM
Accord Hlthcare
September 13, 2012ANDA200243 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Lannett Co Inc
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 5, 2012ANDA202239 Amlodipine besylate and benazepril hydrochloride
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Aurobindo Pharma Ltd
August 15, 2012ANDA078889 Metoprolol
METOPROLOL SUCCINATE
Reddys
August 3, 2012ANDA090984 Montelukast
MONTELUKAST SODIUM
Torrent Pharms Ltd
August 3, 2012ANDA200405 Montelukast
MONTELUKAST SODIUM
Lannett Co Inc
August 3, 2012ANDA201515 Montelukast
MONTELUKAST SODIUM
Torrent Pharms Ltd
August 3, 2012ANDA202468 Montelukast
MONTELUKAST SODIUM
Aurobindo Pharma Ltd
July 26, 2012ANDA202677 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN
Alvogen
July 25, 2012ANDA065489 Clarithromycin
CLARITHROMYCIN
Aurobindo
June 29, 2012ANDA202759 Glimepiride
GLIMEPIRIDE
Aurobindo Pharma Ltd
May 29, 2012ANDA090548 Atorvastatin
ATORVASTATIN CALCIUM
Apotex Inc
May 17, 2012ANDA076999 Clopidogrel
CLOPIDOGREL BISULFATE
Teva
May 17, 2012ANDA090540 Clopidogrel
CLOPIDOGREL BISULFATE
Aurobindo Pharma Ltd
May 1, 2012ANDA091244 Testosterone cypionate
TESTOSTERONE CYPIONATE
Hikma Farmaceutica
April 23, 2012ANDA090798 Olanzapine
OLANZAPINE
Apotex Inc
April 13, 2012ANDA200294 Meclizine hydrochloride
MECLIZINE HYDROCHLORIDE
Epic Pharma LLC
April 11, 2012ANDA201013 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Aurolife Pharma LLC
April 3, 2012ANDA201506 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE
Jubilant Generics
March 30, 2012ANDA077369 Irbesartan and hydrochlorothiazide
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Teva
March 27, 2012ANDA077745 Quetiapine
QUETIAPINE FUMARATE
Teva Pharms
March 27, 2012ANDA091388 Quetiapine
QUETIAPINE FUMARATE
Aurobindo Pharma Ltd
March 27, 2012ANDA202152 Quetiapine
QUETIAPINE FUMARATE
Accord Hlthcare
March 2, 2012ANDA077561 Ziprasidone
ZIPRASIDONE HYDROCHLORIDE
Apotex
February 24, 2012ANDA090356 Naltrexone hydrochloride
NALTREXONE HYDROCHLORIDE
Sun Pharm
February 17, 2012ANDA091617 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Alembic Pharms Ltd
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 20, 2011ANDA091605 Doxycycline
DOXYCYCLINE
Heritage
December 20, 2011ANDA201090 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Aurobindo Pharma Ltd
December 20, 2011ANDA201091 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Aurobindo Pharma Ltd
December 9, 2011ANDA201407 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Lannett Co Inc
December 7, 2011ANDA201384 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Sun Pharm
November 30, 2011ANDA076477 Atorvastatin
ATORVASTATIN CALCIUM
Sun Pharm Inds Ltd
November 28, 2011ANDA202075 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Strides Pharma
October 31, 2011ANDA200629 Naproxen
NAPROXEN SODIUM
Aurobindo Pharma Ltd
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 26, 2011ANDA090695 Loxapine
LOXAPINE SUCCINATE
Lannett Co Inc
September 19, 2011ANDA091325 Norethindrone
NORETHINDRONE
Lupin Ltd
September 19, 2011ANDA091432 Naproxen
NAPROXEN
Nuvo Pharms Inc
August 29, 2011ANDA200503 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Lupin Ltd
August 24, 2011ANDA201003 Risperidone
RISPERIDONE
Ajanta Pharma Ltd
August 22, 2011ANDA090199 Levocetirizine dihydrochloride
LEVOCETIRIZINE DIHYDROCHLORIDE
Teva Pharms
August 3, 2011ANDA090700 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Glenmark Pharms Ltd
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 20, 2011ANDA201043 Levofloxacin
LEVOFLOXACIN
Aurobindo Pharma Ltd
June 13, 2011ANDA091083 Nabumetone
NABUMETONE
Watson Labs
June 8, 2011ANDA090480 Mupirocin
MUPIROCIN
Glenmark Pharms
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, 2011ANDA090289 Letrozole
LETROZOLE
Teva Pharms
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 22, 2011ANDA201006 Latanoprost
LATANOPROST
Bausch and Lomb
March 7, 2011ANDA078423 Fluconazole
FLUCONAZOLE
Ani Pharms
February 28, 2011ANDA078048 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Kvk Tech
February 28, 2011ANDA090937 Glyburide
GLYBURIDE
Heritage
February 24, 2011ANDA090385 Levocetirizine dihydrochloride
LEVOCETIRIZINE DIHYDROCHLORIDE
Glenmark Pharms Ltd
January 20, 2011ANDA078281 Pantoprazole sodium
PANTOPRAZOLE SODIUM
Lannett Co Inc
January 12, 2011ANDA091211 Atovaquone and proguanil hydrochloride
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
Glenmark Pharms Ltd
December 22, 2010ANDA091276 Indomethacin
INDOMETHACIN
Glenmark Pharms Ltd
December 21, 2010ANDA090796 Ibuprofen
IBUPROFEN
Pharmazone
December 20, 2010ANDA090836 Cephalexin
CEPHALEXIN
Alkem Labs Ltd
December 17, 2010ANDA090858 Gabapentin
GABAPENTIN
Alkem
December 14, 2010ANDA078932 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Alembic Pharms Ltd
December 1, 2010ANDA090066 Diclofenac
DICLOFENAC SODIUM
Unique
October 15, 2010ANDA091269 Lansoprazole
LANSOPRAZOLE
DR Reddys Labs Ltd
October 6, 2010ANDA078243 Losartan potassium
LOSARTAN POTASSIUM
Zydus Pharms USA Inc
October 6, 2010ANDA090083 Losartan potassium
LOSARTAN POTASSIUM
Aurobindo Pharma
October 6, 2010ANDA090382 Losartan potassium
LOSARTAN POTASSIUM
Strides Pharma
October 6, 2010ANDA091629 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Aurobindo Pharma
August 3, 2010ANDA090455 Ergocalciferol
ERGOCALCIFEROL
Onesource
July 23, 2010ANDA090478 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Invagen Pharms
July 22, 2010ANDA091209 Norethindrone
NORETHINDRONE
Glenmark Pharms Ltd
July 15, 2010ANDA090931 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE
Sun Pharm Inds Ltd
June 28, 2010ANDA076565 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Teva
June 28, 2010ANDA090568 Anastrozole
ANASTROZOLE
Accord Hlthcare
June 23, 2010ANDA078728 Glipizide and metformin hydrochloride
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Heritage
June 10, 2010ANDA090456 Mycophenolate mofetil
MYCOPHENOLATE MOFETIL
Strides Pharma
June 7, 2010ANDA065496 Cefuroxime axetil
CEFUROXIME AXETIL
Alkem Labs Ltd
June 4, 2010ANDA040659 Meclizine hydrochloride
MECLIZINE HYDROCHLORIDE
Jubilant Cadista
June 4, 2010ANDA077714 Terbinafine hydrochloride
TERBINAFINE HYDROCHLORIDE
Breckenridge Pharm
May 24, 2010ANDA090682 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE
Aurobindo Pharma
April 22, 2010ANDA090564 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Granules India
April 12, 2010ANDA090469 Ondansetron
ONDANSETRON
Aurobindo Pharma
April 7, 2010ANDA078414 Amlodipine
AMLODIPINE BESYLATE
Oxford Pharms
April 6, 2010ANDA077157 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Teva Pharms
April 6, 2010ANDA078866 Bupropion
BUPROPION HYDROCHLORIDE
Sun Pharm
February 26, 2010ANDA040858 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE
Heritage Pharms Inc
February 23, 2010ANDA090121 Finasteride
FINASTERIDE
Accord Hlthcare
February 16, 2010ANDA090624 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Aurobindo Pharma
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 10, 2009ANDA077255 Lansoprazole
LANSOPRAZOLE
Teva Pharms
November 6, 2009ANDA090200 Methocarbamol
METHOCARBAMOL
Hetero Labs Ltd III
November 5, 2009ANDA076109 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Apotex
November 5, 2009ANDA076583 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Sandoz
November 5, 2009ANDA078434 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Chartwell Rx
September 25, 2009ANDA090702 Lithium carbonate
LITHIUM CARBONATE
Hetero Labs Ltd III
September 18, 2009ANDA078504 Baclofen
BACLOFEN
Northstar Hlthcare
September 17, 2009ANDA078906 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Glenmark Pharms Ltd
August 26, 2009ANDA065442 Clindamycin
CLINDAMYCIN HYDROCHLORIDE
Aurobindo Pharma
August 26, 2009ANDA078895 Clonidine
CLONIDINE HYDROCHLORIDE
Unichem
August 18, 2009ANDA078635 Bisoprolol fumarate
BISOPROLOL FUMARATE
Unichem
August 10, 2009ANDA065461 Tacrolimus
TACROLIMUS
Sandoz
August 10, 2009ANDA076554 Sumatriptan
SUMATRIPTAN SUCCINATE
Sun Pharm Inds Ltd
August 10, 2009ANDA076847 Sumatriptan
SUMATRIPTAN SUCCINATE
DR Reddys Labs Inc
August 10, 2009ANDA078284 Sumatriptan
SUMATRIPTAN SUCCINATE
Orbion Pharms
August 10, 2009ANDA078295 Sumatriptan
SUMATRIPTAN SUCCINATE
Sun Pharm Inds
August 10, 2009ANDA078327 Sumatriptan
SUMATRIPTAN SUCCINATE
Aurobindo Pharma
July 29, 2009NDA022352 Colchicine
COLCRYS
Takeda Pharms USA
July 6, 2009ANDA078917 Bicalutamide
BICALUTAMIDE
Accord Hlthcare
July 6, 2009ANDA079110 Bicalutamide
BICALUTAMIDE
Sun Pharm
June 18, 2009ANDA077789 Chlorhexidine gluconate
CHLORHEXIDINE GLUCONATE
Pharmobedient
May 22, 2009ANDA078916 Famotidine
FAMOTIDINE
Alembic Pharms Ltd
May 4, 2009ANDA078925 Amlodipine
AMLODIPINE BESYLATE
Alkem
April 30, 2009ANDA077954 Azelastine hydrochloride
AZELASTINE HYDROCHLORIDE
Apotex Inc
April 17, 2009ANDA078490 Omeprazole
OMEPRAZOLE
DR Reddys Labs Ltd
March 27, 2009ANDA076343 Topiramate
TOPIRAMATE
Cipla Ltd
March 27, 2009ANDA077627 Topiramate
TOPIRAMATE
Glenmark Pharms Ltd
March 27, 2009ANDA078235 Topiramate
TOPIRAMATE
Zydus Pharms USA Inc
March 27, 2009ANDA079162 Topiramate
TOPIRAMATE
Invagen Pharms
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
February 27, 2009ANDA078246 Buspirone
BUSPIRONE HYDROCHLORIDE
Aurobindo Pharma Ltd
February 25, 2009ANDA078559 Ofloxacin
OFLOXACIN
Fdc Ltd
February 9, 2009ANDA076572 Sumatriptan
SUMATRIPTAN SUCCINATE
Sun Pharm Inds Ltd
February 6, 2009ANDA078593 Sumatriptan
SUMATRIPTAN SUCCINATE
Wockhardt Bio AG
February 5, 2009ANDA078329 Ibuprofen
IBUPROFEN
Strides Pharma
January 15, 2009ANDA078154 Levetiracetam
LEVETIRACETAM
Lupin
January 12, 2009ANDA040796 Folic acid
FOLIC ACID
Leading
November 25, 2008ANDA078853 Divalproex sodium
DIVALPROEX SODIUM
Orbion Pharms
October 16, 2008ANDA078040 Risperidone
RISPERIDONE
Zydus Pharms USA Inc
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
August 15, 2008ANDA077285 Bupropion
BUPROPION HYDROCHLORIDE
Watson Labs Inc
August 4, 2008ANDA090124 Alendronate sodium
ALENDRONATE SODIUM
Aurobindo Pharma
July 24, 2008ANDA065329 Ceftriaxone sodium
CEFTRIAXONE
Acs Dobfar
June 30, 2008ANDA077568 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE
Fdc Ltd
June 20, 2008ANDA076601 Cetirizine
CETIRIZINE HYDROCHLORIDE
Taro
June 13, 2008ANDA077653 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Zydus Pharms USA
June 9, 2008ANDA077626 Ramipril
RAMIPRIL
Lupin
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 28, 2008ANDA078541 Mometasone furoate
MOMETASONE FUROATE
Glenmark Pharms
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 18, 2008ANDA078218 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Chartwell Rx
April 17, 2008ANDA078321 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Cspc Ouyi
April 15, 2008ANDA076407 Ofloxacin
OFLOXACIN
Sentiss
March 31, 2008ANDA040886 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Kvk Tech
March 21, 2008ANDA040875 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Kvk Tech
March 17, 2008ANDA076128 Ofloxacin
OFLOXACIN
Bausch and Lomb Inc
March 11, 2008ANDA065470 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE
Aurobindo Pharma
February 28, 2008ANDA040751 Imipramine
IMIPRAMINE HYDROCHLORIDE
Oxford Pharms
February 26, 2008ANDA078155 Simvastatin
SIMVASTATIN
Accord Hlthcare
January 31, 2008ANDA078619 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Aurobindo Pharma
January 31, 2008ANDA078787 Gabapentin
GABAPENTIN
Aurobindo Pharma
January 7, 2008ANDA065434 Cefdinir
CEFDINIR
Aurobindo Pharma
December 31, 2007ANDA076749 Ipratropium bromide and albuterol sulfate
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Nephron
December 17, 2007ANDA078302 Buspirone
BUSPIRONE HYDROCHLORIDE
Oxford Pharms
December 14, 2007ANDA040734 Methimazole
METHIMAZOLE
Heritage Pharma
December 14, 2007ANDA065473 Cefdinir
CEFDINIR
Aurobindo Pharma
November 27, 2007ANDA040778 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN
Amneal Pharms Ny
November 1, 2007ANDA078296 Lovastatin
LOVASTATIN
Lupin
October 22, 2007ANDA075576 Omeprazole
OMEPRAZOLE
DR Reddys Labs Ltd
October 22, 2007ANDA076048 Omeprazole
OMEPRAZOLE
Apotex
October 17, 2007NDA022122 Diclofenac
VOLTAREN ARTHRITIS PAIN
Haleon Us Holdings
October 12, 2007NDA022145 Raltegravir
ISENTRESS, ISENTRESS HD
Msd Sub Merck
October 9, 2007ANDA077802 Oxcarbazepine
OXCARBAZEPINE
Glenmark Pharms Ltd
September 28, 2007ANDA076527 Ofloxacin
OFLOXACIN
Apotex Inc
September 26, 2007ANDA077073 Amlodipine
AMLODIPINE BESYLATE
Cipla
September 12, 2007ANDA077538 Fluticasone propionate
FLUTICASONE PROPIONATE
Apotex
September 11, 2007ANDA077739 Metoprolol
METOPROLOL TARTRATE
Aurobindo Pharma
September 5, 2007ANDA076373 Carvedilol
CARVEDILOL
Teva
September 5, 2007ANDA077614 Carvedilol
CARVEDILOL
Zydus Pharms USA Inc
September 5, 2007ANDA078251 Carvedilol
CARVEDILOL
Glenmark Pharms Ltd
September 5, 2007ANDA078332 Carvedilol
CARVEDILOL
Aurobindo Pharma
September 5, 2007ANDA078384 Carvedilol
CARVEDILOL
Regcon Holdings
August 24, 2007ANDA078457 Quinapril
QUINAPRIL HYDROCHLORIDE
Invagen Pharms
August 23, 2007ANDA078181 Glimepiride
GLIMEPIRIDE
Accord Hlthcare
August 22, 2007ANDA077666 Mirtazapine
MIRTAZAPINE
Apotex
August 17, 2007ANDA077903 Zolpidem tartrate
ZOLPIDEM TARTRATE
Torrent Pharms
August 13, 2007ANDA065358 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Sandoz Inc
August 10, 2007ANDA078494 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE
Actavis Elizabeth
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 25, 2007ANDA040749 Benzonatate
BENZONATATE
Thepharmanetwork LLC
July 25, 2007ANDA078406 Paroxetine
PAROXETINE HYDROCHLORIDE
Aurobindo Pharma
July 12, 2007ANDA078043 Amlodipine
AMLODIPINE BESYLATE
Lupin
July 2, 2007ANDA077533 Terbinafine hydrochloride
TERBINAFINE HYDROCHLORIDE
Invagen Pharms
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 13, 2007ANDA077715 Bupropion
BUPROPION HYDROCHLORIDE
Actavis Labs Fl Inc
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 4, 2007ANDA065332 Cefdinir
CEFDINIR
Teva Pharms
April 26, 2007ANDA077859 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE
Aurobindo Pharma
April 23, 2007ANDA076410 Zolpidem tartrate
ZOLPIDEM TARTRATE
Teva
April 23, 2007ANDA077214 Zolpidem tartrate
ZOLPIDEM TARTRATE
Pharmazone
April 23, 2007ANDA077322 Zolpidem tartrate
ZOLPIDEM TARTRATE
Sandoz
April 19, 2007ANDA078214 Danazol
DANAZOL
Lannett
April 6, 2007ANDA065330 Cefdinir
CEFDINIR
Chartwell Rx
March 30, 2007ANDA040627 Benzonatate
BENZONATATE
Thepharmanetwork LLC
March 28, 2007ANDA078250 Naproxen
NAPROXEN
Glenmark Pharms Ltd
March 27, 2007ANDA078216 Citalopram
CITALOPRAM HYDROBROMIDE
Torrent Pharms
March 26, 2007ANDA065378 Amoxicillin
AMOXICILLIN
Sandoz
March 26, 2007ANDA065387 Amoxicillin
AMOXICILLIN
Sandoz
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 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
December 28, 2006ANDA065334 Amoxicillin
AMOXICILLIN
Aurobindo
December 20, 2006ANDA077691 Simvastatin
SIMVASTATIN
Aurobindo Pharma
December 20, 2006ANDA077927 Meloxicam
MELOXICAM
Unichem
December 15, 2006ANDA077415 Bupropion
BUPROPION HYDROCHLORIDE
Impax Labs
December 7, 2006ANDA077918 Meloxicam
MELOXICAM
Yung Shin Pharm
October 23, 2006ANDA076341 Pravastatin sodium
PRAVASTATIN SODIUM
Apotex
September 27, 2006ANDA077912 Lisinopril and hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Lupin
September 13, 2006ANDA077443 Atenolol
ATENOLOL
Unique
September 5, 2006ANDA040684 Phenytoin
EXTENDED PHENYTOIN SODIUM
Taro
August 29, 2006ANDA040750 Spironolactone
SPIRONOLACTONE
Oxford Pharms
August 25, 2006ANDA040736 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Amneal Pharms Ny
August 25, 2006ANDA040746 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Amneal Pharms Ny
August 18, 2006ANDA077662 Gabapentin
GABAPENTIN
Glenmark Pharms Ltd
July 31, 2006ANDA040712 Promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE
Kvk Tech
July 27, 2006ANDA077836 Gemfibrozil
GEMFIBROZIL
Invagen Pharms
July 19, 2006ANDA077929 Meloxicam
MELOXICAM
Cipla
July 6, 2006ANDA065246 Azithromycin
AZITHROMYCIN
Pliva
July 5, 2006ANDA040616 Warfarin sodium
WARFARIN SODIUM
Pliva
June 28, 2006ANDA077856 Clonazepam
CLONAZEPAM
Prinston Inc
June 20, 2006ANDA077690 Quinapril
QUINAPRIL HYDROCHLORIDE
Lupin
June 19, 2006ANDA065322 Amoxicillin
AMOXICILLIN
Hikma
June 19, 2006ANDA065325 Amoxicillin
AMOXICILLIN
Hikma
May 31, 2006ANDA065259 Cefdinir
CEFDINIR
Lupin
May 10, 2006NDA021928 Varenicline tartrate
CHANTIX
Pf Prism Cv
April 24, 2006ANDA076056 Pravastatin sodium
PRAVASTATIN SODIUM
Aurobindo Pharma USA
April 21, 2006ANDA040560 Theophylline
THEOPHYLLINE
Mpp Pharma
March 29, 2006ANDA065255 Amoxicillin
AMOXICILLIN
Hikma
March 17, 2006ANDA077634 Zonisamide
ZONISAMIDE
Sun Pharm Inds (In)
February 22, 2006ANDA076504 Fluticasone propionate
FLUTICASONE PROPIONATE
Hikma
February 14, 2006ANDA040649 Promethazine hydrochloride and dextromethorphan hydrobromide
PROMETHAZINE DM
Pai Holdings
February 3, 2006ANDA076820 Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE
Amneal Pharms
January 31, 2006NDA021908 Lubiprostone
AMITIZA
Sucampo Pharma LLC
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
November 25, 2005ANDA065229 Cephalexin
CEPHALEXIN
Lupin
November 21, 2005ANDA077127 Nifedipine
NIFEDIPINE
Osmotica Pharm Us
November 18, 2005ANDA040596 Promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE
Zydus Pharms USA
November 16, 2005ANDA065253 Cephalexin
CEPHALEXIN
Aurobindo Pharma
November 14, 2005ANDA065211 Azithromycin
AZITHROMYCIN
Sandoz
November 14, 2005ANDA065212 Azithromycin
AZITHROMYCIN
Sandoz
November 14, 2005ANDA065223 Azithromycin
AZITHROMYCIN
Pliva
November 14, 2005ANDA065225 Azithromycin
AZITHROMYCIN
Pliva
November 9, 2005ANDA065256 Amoxicillin
AMOXICILLIN
Aurobindo
November 9, 2005ANDA065271 Amoxicillin
AMOXICILLIN
Aurobindo
November 9, 2005ANDA077293 Furosemide
FUROSEMIDE
Leading
October 7, 2005ANDA076817 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Vista Pharms
October 6, 2005ANDA077091 Glimepiride
GLIMEPIRIDE
DR Reddys Labs Ltd
September 29, 2005ANDA077309 Acyclovir
ACYCLOVIR
Apotex
September 28, 2005ANDA075677 Acyclovir
ACYCLOVIR
Apotex
September 28, 2005ANDA077246 Danazol
DANAZOL
Lannett Co Inc
September 23, 2005ANDA065170 Mupirocin
MUPIROCIN
Sun Pharma Canada
September 9, 2005ANDA077321 Lisinopril
LISINOPRIL
Lupin
September 2, 2005NDA021774 Zolpidem tartrate
AMBIEN CR
Cosette
August 25, 2005ANDA065136 Clarithromycin
CLARITHROMYCIN
Sandoz
August 17, 2005ANDA065234 Cephalexin
CEPHALEXIN
Lupin
July 13, 2005ANDA065228 Amoxicillin
AMOXICILLIN
Sandoz
June 6, 2005ANDA040611 Prednisone
PREDNISONE
Jubilant Cadista
May 9, 2005ANDA065169 Ceftriaxone sodium
CEFTRIAXONE
Sandoz
May 2, 2005ANDA077147 Clonazepam
CLONAZEPAM
Accord Hlthcare
April 25, 2005ANDA076913 Prednisolone
PREDNISOLONE SODIUM PHOSPHATE
Pharm Assoc
April 11, 2005ANDA076942 Ketoconazole
KETOCONAZOLE
Cosette Pharms Nc
April 6, 2005ANDA075360 Gabapentin
GABAPENTIN
Granules
April 5, 2005ANDA077066 Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Sandoz
March 23, 2005ANDA075477 Gabapentin
GABAPENTIN
Cspc Ouyi
March 11, 2005NDA021730 Levalbuterol
XOPENEX HFA
Lupin
February 24, 2005ANDA040586 Primidone
PRIMIDONE
Oxford Pharms
January 27, 2005ANDA076899 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Amneal Pharms Ny
January 25, 2005ANDA065191 Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Hikma Pharms
January 14, 2005ANDA077095 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Aurobindo
December 28, 2004ANDA040604 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Epic Pharma LLC
December 21, 2004ANDA076679 Mometasone furoate
MOMETASONE FUROATE
Sun Pharma Canada
December 20, 2004ANDA075317 Terazosin hydrochloride
TERAZOSIN HYDROCHLORIDE
Jubilant Cadista
October 29, 2004NDA021457 Albuterol sulfate
PROAIR HFA
Teva Branded Pharm
October 28, 2004ANDA077031 Citalopram
CITALOPRAM HYDROBROMIDE
Aurobindo
October 22, 2004ANDA076921 Mirtazapine
MIRTAZAPINE
Aurobindo
September 23, 2004ANDA076925 Ibuprofen
IBUPROFEN
Padagis Us
September 10, 2004ANDA076639 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE
Unique
June 9, 2004ANDA076126 Ciprofloxacin
CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE
Carlsbad
May 25, 2004ANDA065089 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Chartwell Rx
May 14, 2004ANDA076451 Fluticasone propionate
FLUTICASONE PROPIONATE
Fougera Pharms
May 14, 2004ANDA076513 Ofloxacin
OFLOXACIN
Apotex Inc
May 14, 2004ANDA076622 Ofloxacin
OFLOXACIN
Bausch and Lomb
March 16, 2004ANDA076593 Ciprofloxacin
CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE
Aiping Pharm Inc
March 12, 2004ANDA065162 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Chartwell Rx
February 11, 2004ANDA076118 Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE
Prinston Inc
January 16, 2004ANDA076533 Tizanidine
TIZANIDINE HYDROCHLORIDE
Apotex
December 9, 2003ANDA076592 Betamethasone dipropionate
BETAMETHASONE DIPROPIONATE
Padagis Israel
November 7, 2003ANDA065085 Mupirocin
MUPIROCIN
Teva
November 7, 2003ANDA065123 Mupirocin
MUPIROCIN
Padagis Israel
November 7, 2003ANDA075563 Sotalol hydrochloride
SOTALOL HYDROCHLORIDE
Oxford Pharms
October 23, 2003ANDA040526 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Sun Pharm Industries
September 29, 2003ANDA076416 Tizanidine
TIZANIDINE HYDROCHLORIDE
Sun Pharm Inds Inc
September 12, 2003ANDA075350 Gabapentin
GABAPENTIN
Actavis Elizabeth
July 1, 2003ANDA076510 Desoximetasone
DESOXIMETASONE
Padagis Israel
May 30, 2003ANDA076380 Norethindrone acetate and ethinyl estradiol
JUNEL 1/20
Barr Labs
March 13, 2003ANDA076174 Etodolac
ETODOLAC
Taro
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 18, 2002ANDA075638 Ketoconazole
KETOZOLE
Sun Pharma Canada
December 4, 2002ANDA065119 Amoxicillin
AMOXICILLIN
Chartwell Rx
December 3, 2002ANDA076004 Etodolac
ETODOLAC
Apotex
November 1, 2002ANDA075410 Omeprazole
OMEPRAZOLE
Lannett Co Inc
October 30, 2002ANDA065101 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Chartwell Rx
October 28, 2002ANDA075882 Flecainide acetate
FLECAINIDE ACETATE
Ani Pharms
October 24, 2002NDA021116 Levothyroxine
THYRO-TABS
Alvogen
October 21, 2002ANDA076225 Norethindrone
ERRIN
DR Reddys Labs SA
September 26, 2002ANDA076140 Sotalol hydrochloride
SOTALOL HYDROCHLORIDE
Apotex
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 20, 2002ANDA076003 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Amneal Pharms
June 5, 2002ANDA075991 Lovastatin
LOVASTATIN
Carlsbad
May 9, 2002ANDA075388 Buspirone
BUSPIRONE HYDROCHLORIDE
Oxford Pharms
April 10, 2002ANDA075604 Potassium chloride
POTASSIUM CHLORIDE
Actavis Labs Fl Inc
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
February 12, 2002ANDA075281 Diclofenac
DICLOFENAC SODIUM
Aurobindo Pharma USA
January 29, 2002ANDA075452 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Teva
January 29, 2002ANDA076001 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Teva Pharms USA
December 18, 2001ANDA075927 Naproxen
NAPROXEN
Amneal Pharms Ny
December 17, 2001ANDA075551 Lovastatin
LOVASTATIN
Teva
November 14, 2001ANDA075682 Ibuprofen
IBUPROFEN
DR Reddys
October 12, 2001ANDA064163 Gentamicin sulfate
GENTAK
Pharmobedient
August 29, 2001ANDA040362 Prednisone
PREDNISONE
Jubilant Cadista
June 13, 2001ANDA075795 Glipizide
GLIPIZIDE
Apotex
May 31, 2001ANDA040419 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Specgx LLC
April 19, 2001NDA020983 Albuterol sulfate
VENTOLIN HFA
Glaxosmithkline
April 16, 2001ANDA075511 Famotidine
FAMOTIDINE
Ivax Sub Teva Pharms
April 16, 2001ANDA075718 Famotidine
FAMOTIDINE
DR Reddys Labs Ltd
April 16, 2001ANDA075805 Famotidine
FAMOTIDINE
Carlsbad
February 2, 2001ANDA065061 Clindamycin
CLINDAMYCIN HYDROCHLORIDE
Sun Pharm Inds Ltd
January 31, 2001ANDA075855 Oxaprozin
OXAPROZIN
DR Reddys Labs Ltd
January 23, 2001ANDA075657 Enalapril maleate
ENALAPRIL MALEATE
Taro
December 1, 2000ANDA065055 Doxycycline
DOXYCYCLINE
Strides Pharma Intl
November 30, 2000ANDA065062 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE
Torrent
October 20, 2000ANDA040409 Hydrocodone bitartrate and acetaminophen
ANEXSIA 5/325
Specgx LLC
October 18, 2000ANDA075580 Doxazosin
DOXAZOSIN MESYLATE
Apotex
September 29, 2000NDA020833 Fluticasone propionate
FLOVENT DISKUS 100, FLOVENT DISKUS 250, FLOVENT DISKUS 50
Glaxo Grp Ltd
August 24, 2000NDA021077 Fluticasone propionate and salmeterol
ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, ADVAIR DISKUS 500/50
Glaxo Grp Ltd
August 21, 2000NDA021210 Levothyroxine
UNITHROID
Stevens J
July 31, 2000ANDA075665 Etodolac
ETODOLAC
Teva
July 26, 2000ANDA040400 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Specgx LLC
May 8, 2000ANDA075520 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE
Taro
May 1, 2000ANDA075429 Sotalol hydrochloride
SOTALOL HYDROCHLORIDE
Teva
May 1, 2000NDA021134 Nitroglycerin
NITROSTAT
Viatris
February 15, 2000ANDA040327 Orphenadrine citrate
ORPHENADRINE CITRATE
Sandoz
February 11, 2000ANDA075492 Diclofenac
DICLOFENAC SODIUM
Vpna
September 16, 1999ANDA075126 Etodolac
ETODOLAC
Ani Pharms
June 16, 1999ANDA075282 Cromolyn sodium
CROMOLYN SODIUM
Sandoz
April 30, 1999ANDA075382 Acyclovir
ACYCLOVIR
Carlsbad
February 26, 1999ANDA040230 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Lannett
January 26, 1999ANDA075090 Acyclovir
ACYCLOVIR
Regcon Holdings
December 17, 1998ANDA065006 Polymyxin b sulfate and trimethoprim sulfate
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Epic Pharma LLC
November 20, 1998ANDA075229 Diclofenac
DICLOFENAC POTASSIUM
Rubicon Research
November 13, 1998ANDA075185 Diclofenac
DICLOFENAC SODIUM
Carlsbad
October 5, 1998ANDA075150 Clonazepam
CLONAZEPAM
Aurobindo Pharma USA
August 3, 1998ANDA075133 Labetalol
LABETALOL HYDROCHLORIDE
Watson Labs
June 19, 1998ANDA040284 Orphenadrine citrate
ORPHENADRINE CITRATE
Lupin
June 8, 1998ANDA074415 Sucralfate
SUCRALFATE
Chartwell Rx
April 13, 1998ANDA064211 Polymyxin b sulfate and trimethoprim sulfate
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Sandoz
March 25, 1998ANDA074909 Alprazolam
ALPRAZOLAM
Sandoz
March 25, 1998ANDA074978 Ibuprofen
IBUPROFEN
Actavis Mid Atlantic
February 27, 1998ANDA040268 Prochlorperazine
PROCOMP
Jubilant Cadista
November 26, 1997ANDA040039 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Taro
October 31, 1997ANDA040189 Methylprednisolone
METHYLPREDNISOLONE
Jubilant Cadista
October 31, 1997ANDA074891 Acyclovir
ACYCLOVIR
Heritage
October 22, 1997ANDA040197 Estradiol
ESTRADIOL
Barr Labs Inc
September 17, 1997ANDA074880 Albuterol sulfate
ALBUTEROL SULFATE
Nephron
June 5, 1997ANDA074821 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Sandoz
May 16, 1997ANDA074754 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Teva
March 7, 1997ANDA040188 Carisoprodol
CARISOPRODOL
Oxford Pharms
February 28, 1997ANDA074673 Guanfacine
GUANFACINE HYDROCHLORIDE
Epic Pharma LLC
February 14, 1997ANDA064120 Polymyxin b sulfate and trimethoprim sulfate
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Bausch and Lomb Inc
December 27, 1996NDA020504 Hydrochlorothiazide
MICROZIDE
Teva Branded Pharm
November 21, 1996ANDA074700 Bumetanide
BUMETANIDE
Sandoz
September 30, 1996ANDA074392 Clobetasol propionate
CLOBETASOL PROPIONATE
Fougera Pharms Inc
September 10, 1996ANDA074569 Clonazepam
CLONAZEPAM
Teva
August 28, 1996ANDA064065 Neomycin sulfate, polymyxin b sulfate and hydrocortisone
OTICAIR
Bausch and Lomb Inc
August 15, 1996NDA020503 Albuterol sulfate
PROVENTIL-HFA
Kindeva
August 9, 1996ANDA040159 Medroxyprogesterone acetate
MEDROXYPROGESTERONE ACETATE
Barr
July 30, 1996ANDA074623 Lactulose
LACTULOSE
Pharm Assoc
July 18, 1996ANDA064030 Erythromycin
ERYTHROMYCIN
Sentiss
July 15, 1996ANDA040156 Hydroxyzine
HYDROXYZINE PAMOATE
Impax Labs Inc
May 31, 1996NDA050725 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AUGMENTIN '200', AUGMENTIN '400'
Us Antibiotics
March 29, 1996ANDA070848 Sucralfate
SUCRALFATE
Teva
March 26, 1996ANDA074514 Diclofenac
DICLOFENAC SODIUM
Actavis Elizabeth
February 13, 1996NDA050720 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AUGMENTIN '875'
Us Antibiotics
January 31, 1996ANDA064096 Tobramycin
AKTOB
Epic Pharma LLC
December 29, 1995ANDA064053 Neomycin sulfate, polymyxin b sulfate and hydrocortisone
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Bausch and Lomb Inc
December 29, 1995ANDA074112 Alprazolam
ALPRAZOLAM
Sandoz
September 13, 1995ANDA064135 Neomycin sulfate, polymyxin b sulfate and dexamethasone
DEXASPORIN
Bausch and Lomb Inc
August 31, 1995ANDA064093 Gentamicin sulfate
GENTAMICIN SULFATE
Sciegen Pharms
August 29, 1995ANDA074388 Glyburide
GLYBURIDE
Teva
May 31, 1995ANDA074185 Diltiazem
DILTIAZEM HYDROCHLORIDE
Teva
April 27, 1995ANDA074453 Metoprolol
METOPROLOL TARTRATE
Adaptis
March 27, 1995ANDA074132 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE
Teva
February 27, 1995ANDA074223 Glipizide
GLIPIZIDE
Watson Labs Teva
January 18, 1995ANDA074056 Atenolol
ATENOLOL
Teva
January 4, 1995ANDA074447 Flurbiprofen
FLURBIPROFEN SODIUM
Bausch and Lomb
December 28, 1994ANDA040066 Sulfacetamide sodium
SULFACETAMIDE SODIUM
Bausch and Lomb
November 28, 1994ANDA074378 Glipizide
GLIPIZIDE
Oxford Pharms
September 30, 1994ANDA040037 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Sun Pharma Canada
September 30, 1994ANDA064076 Amoxicillin
AMOXICILLIN
Sandoz
July 29, 1994ANDA064067 Erythromycin
ERYTHROMYCIN
Bausch and Lomb Inc
July 25, 1994ANDA064063 Neomycin sulfate, polymyxin b sulfate and dexamethasone
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
Bausch and Lomb Inc
May 17, 1994ANDA074151 Cimetidine
CIMETIDINE
Teva
May 11, 1994ANDA064048 Gentamicin sulfate
GENTAMICIN SULFATE
Bausch and Lomb Inc
April 29, 1994ANDA064054 Gentamicin sulfate
GENTAMICIN SULFATE
Cosette Pharms Nc
November 29, 1993ANDA064052 Tobramycin
TOBRAMYCIN
Bausch and Lomb Inc
August 31, 1993ANDA072640 Clotrimazole
CLOTRIMAZOLE
Sun Pharma Canada
June 30, 1993NDA020215 Isosorbide mononitrate
MONOKET
Omnivium Pharms
January 29, 1993ANDA064022 Nystatin
NYSTATIN
Sun Pharma Canada
January 29, 1993ANDA081297 Benzonatate
BENZONATATE
Bionpharma
January 28, 1993ANDA073652 Nitrofurantoin
NITROFURANTOIN
Impax Labs Inc
December 22, 1992ANDA064013 Amoxicillin
AMOXICILLIN
Chartwell Rx
March 30, 1992ANDA073556 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE
DR Reddys Labs SA
January 24, 1992ANDA073457 Atenolol
ATENOLOL
Mylan
January 10, 1992NDA019962 Metoprolol
TOPROL-XL
Melinta Therap
December 30, 1991ANDA063181 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE
Watson Labs Teva
December 24, 1991NDA020064 Nitrofurantoin (monohydrate/macrocrystals)
MACROBID
Almatica
October 31, 1991ANDA072926 Lorazepam
LORAZEPAM
Watson Labs
March 25, 1991ANDA072711 Sulindac
SULINDAC
Epic Pharma
December 31, 1990NDA019992 Ciprofloxacin
CILOXAN
Sandoz
July 31, 1989ANDA062938 Neomycin sulfate, polymyxin b sulfate and dexamethasone
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
Padagis Us
November 14, 1988ANDA071655 Oxybutynin
OXYBUTYNIN CHLORIDE
Teva Pharms USA
November 14, 1988ANDA071826 Minoxidil
MINOXIDIL
Ph Health
September 30, 1988ANDA089805 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Strides Pharma Intl
September 12, 1988ANDA071745 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE
Teva Pharms
August 12, 1988ANDA062752 Tetracycline hydrochloride
TETRACYCLINE HYDROCHLORIDE
Chartwell Tetra
July 21, 1988ANDA072234 Baclofen
BACLOFEN
Ivax Sub Teva Pharms
July 21, 1988ANDA072235 Baclofen
BACLOFEN
Ivax Sub Teva Pharms
May 4, 1988ANDA089853 Chlorzoxazone
CHLORZOXAZONE
Aurobindo Pharma Ltd
May 4, 1988ANDA089859 Chlorzoxazone
CHLORZOXAZONE
Watson Labs
March 10, 1988ANDA089682 Hydrocortisone
HYDROCORTISONE
Actavis Mid Atlantic
December 11, 1987ANDA071523 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE
Teva Pharms USA
December 11, 1987ANDA071524 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE
Teva Pharms USA
November 13, 1987ANDA062840 Nystatin
NYSTATIN
Actavis Mid Atlantic
April 21, 1987ANDA071456 Temazepam
TEMAZEPAM
Novel Labs Inc
April 21, 1987ANDA071457 Temazepam
TEMAZEPAM
Novel Labs Inc
March 3, 1987ANDA071344 Minoxidil
MINOXIDIL
Watson Labs
February 13, 1987ANDA062702 Cephalexin
CEPHALEXIN
Teva
February 13, 1987ANDA062703 Cephalexin
CEPHALEXIN
Teva
January 21, 1987ANDA089175 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Pharmobedient
January 9, 1987ANDA071450 Allopurinol
ALLOPURINOL
Sun Pharm Industries
December 10, 1986ANDA071321 Diazepam
DIAZEPAM
Ivax Sub Teva Pharms
December 10, 1986ANDA071322 Diazepam
DIAZEPAM
Ivax Sub Teva Pharms
October 1, 1986ANDA070994 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Watson Labs
August 4, 1986ANDA070322 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE
Innogenix
July 23, 1986ANDA089424 Spironolactone
SPIRONOLACTONE
Sun Pharm Industries
July 10, 1986ANDA062676 Doxycycline
DOXYCYCLINE HYCLATE
Sun Pharm Industries
January 10, 1986ANDA088618 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Pliva
January 10, 1986ANDA088619 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Pliva
December 24, 1985NDA018998 Enalapril maleate
VASOTEC
Bausch
December 23, 1985NDA018810 Silver sulfadiazine
THERMAZENE
Thepharmanetwork LLC
December 19, 1985ANDA070069 Betamethasone valerate
BETA-VAL
Cosette Pharms Nc
November 6, 1985ANDA062488 Neomycin sulfate, polymyxin b sulfate and hydrocortisone
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Sandoz
July 29, 1985ANDA070184 Metoclopramide
METOCLOPRAMIDE HYDROCHLORIDE
Teva
December 14, 1984NDA019048 Desonide
DESOWEN
Galderma Labs LP
December 13, 1984ANDA062535 Tobramycin
TOBREX
Sandoz
December 6, 1984ANDA070027 Metronidazole
METRONIDAZOLE
Teva Pharms USA
December 6, 1984ANDA070033 Metronidazole
METRONIDAZOLE
Pliva
September 28, 1984NDA018832 Allopurinol
ALLOPURINOL
Watson Labs
September 28, 1984NDA018877 Allopurinol
ALLOPURINOL
Watson Labs
September 11, 1984ANDA062500 Doxycycline
DOXYCYCLINE HYCLATE
Chartwell
September 11, 1984ANDA062505 Doxycycline
DOXYCYCLINE HYCLATE
Chartwell
June 15, 1984ANDA088496 Hydroxyzine
HYDROXYZINE PAMOATE
Barr
March 19, 1984ANDA088042 Triamcinolone acetonide
TRIDERM
Crown Labs
December 22, 1983ANDA062474 Nystatin
NYSTATIN
Heritage
December 15, 1983ANDA088481 Dexamethasone
DEXAMETHASONE
Alvogen
August 31, 1983NDA018861 Betamethasone valerate
BETAMETHASONE VALERATE
Fougera
August 25, 1983ANDA062423 Neomycin sulfate, polymyxin b sulfate and hydrocortisone
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Sandoz
April 28, 1983ANDA088237 Dexamethasone
DEXAMETHASONE
Key Therap
April 21, 1983ANDA085025 Hydrocortisone
HYDROCORTISONE
Padagis Us
February 2, 1983ANDA062421 Doxycycline
DOXYCYCLINE HYCLATE
Actavis Labs Fl Inc
December 1, 1982ANDA061931 Amoxicillin
AMOXICILLIN, AMOXICILLIN PEDIATRIC
Chartwell Rx
April 12, 1982ANDA087294 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Chartwell Rx
December 14, 1981ANDA087479 Hydroxyzine
HYDROXYZINE PAMOATE
Sandoz
November 5, 1981ANDA087385 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Padagis Us
October 16, 1981NDA018276 Alprazolam
XANAX
Upjohn
August 17, 1981ANDA086724 Lidocaine
LIDOCAINE
Sun Pharma Canada
November 5, 1980ANDA087059 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Oxford Pharms
November 5, 1980ANDA087068 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Oxford Pharms
July 2, 1980ANDA062196 Gentamicin sulfate
GENTAMICIN SULFATE
Sandoz
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
July 3, 1979ANDA086841 Dapsone
DAPSONE
Everest Life Sci
July 3, 1979ANDA086842 Dapsone
DAPSONE
Everest Life Sci
October 23, 1978ANDA086242 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE
Heritage
July 19, 1978ANDA084612 Dexamethasone
DEXAMETHASONE
Hikma
March 9, 1978ANDA085692 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Fougera Pharms
January 20, 1978ANDA085182 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Heritage
November 30, 1977ANDA085027 Hydrocortisone
HYDROCORTISONE
Padagis Us
November 12, 1976ANDA085162 Prednisone
PREDNISONE
Watson Labs
November 11, 1976ANDA085161 Prednisone
PREDNISONE
Watson Labs
August 17, 1976ANDA085223 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Watson Labs
July 28, 1976ANDA085082 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Watson Labs
May 25, 1976ANDA061966 Nystatin
NYSTATIN
Cosette Pharms Nc
September 30, 1974ANDA084285 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Lannett
September 19, 1973ANDA083426 Promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE
Watson Labs
January 12, 1973ANDA083177 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Ivax Sub Teva Pharms
August 24, 1972ANDA080937 Isoniazid
ISONIAZID
Genus Lifesciences
January 17, 1972ANDA080356 Prednisone
PREDNISONE
Watson Labs
June 5, 1970NDA016620 Nitrofurantoin
MACRODANTIN
Almatica
July 31, 1968ANDA060456 Penicillin v potassium
PENICILLIN-VK
Chartwell Rx
July 3, 1968ANDA060711 Penicillin v potassium
PENICILLIN-VK
Chartwell Rx
February 1, 1965NDA014901 Triamcinolone acetonide
KENALOG-40, KENALOG-80
Apothecon
July 19, 1963NDA050065 Neomycin sulfate, polymyxin b sulfate and dexamethasone
MAXITROL
Sandoz
February 14, 1957NDA010721 Meclizine hydrochloride
ANTIVERT
Casper Pharma LLC
April 18, 1955NDA009768 Hydroxychloroquine sulfate
PLAQUENIL
Advanz Pharma
—ANDA040602 Hydroxyzine—
—ANDA070924 Clonidine—
—ANDA070925 Clonidine—
—ANDA076180 Lisinopril—
—ANDA084283 Prednisone—
—ANDA086414 Triamcinolone acetonide—
—ANDA086989 Methocarbamol—
—ANDA087916 Dexamethasone—

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

Recall timeline

No recall of these products (by NDC code) appears in the FDA enforcement reports.

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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