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Drug company (FDA labeler)

Preferred Pharmaceuticals Inc.

NDC labeler code: 68788

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

889Products (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
June 5, 2025ANDA218321 Fluticasone propionate
FLUTICASONE PROPIONATE
Rubicon Research
October 15, 2024ANDA216328 Ofloxacin
OFLOXACIN
Somerset Theraps LLC
September 20, 2024ANDA215388 Clopidogrel
CLOPIDOGREL BISULFATE
Msn
September 19, 2024ANDA218531 Enalapril maleate
ENALAPRIL MALEATE
Unique Pharm
August 7, 2024ANDA218920 Tizanidine
TIZANIDINE HYDROCHLORIDE
Rising
August 6, 2024ANDA217400 Famotidine
FAMOTIDINE
Msn
May 21, 2024ANDA212447 Albuterol sulfate
ALBUTEROL SULFATE
Armstrong Pharms
May 7, 2024ANDA217566 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Annora Pharma
February 20, 2024ANDA218138 Lidocaine
LIDOCAINE HYDROCHLORIDE VISCOUS
Pai Holdings Pharm
February 7, 2024ANDA216282 Dexamethasone
DEXAMETHASONE
Zydus Lifesciences
January 22, 2024ANDA217917 Fluvoxamine maleate
FLUVOXAMINE MALEATE
Bionpharma
January 18, 2024ANDA214287 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Quagen
December 20, 2023ANDA217669 Famotidine
FAMOTIDINE
Contract Pharmacal
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 12, 2023ANDA214344 Atorvastatin
ATORVASTATIN CALCIUM
Hetero Labs Ltd V
September 6, 2023ANDA217334 Estradiol
ESTRADIOL
Novitium Pharma
August 17, 2023ANDA217652 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Graviti Pharms
August 14, 2023ANDA217396 Losartan potassium
LOSARTAN POTASSIUM
Msn
August 4, 2023ANDA217916 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Bionpharma
August 3, 2023ANDA217748 Allopurinol
ALLOPURINOL
Hetero Labs Ltd V
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
May 31, 2023ANDA216800 Bupropion
BUPROPION HYDROCHLORIDE
Annora Pharma
May 19, 2023ANDA217411 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE
Rising
May 18, 2023ANDA217390 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Granules
May 3, 2023ANDA215705 Sucralfate
SUCRALFATE
Zydus Lifesciences
April 21, 2023ANDA217128 Metronidazole
METRONIDAZOLE
Zydus Lifesciences
April 19, 2023ANDA217001 Dexamethasone
DEXAMETHASONE
Bionpharma
April 4, 2023ANDA217478 Prochlorperazine
PROCHLORPERAZINE MALEATE
Bionpharma
March 28, 2023ANDA216780 Lidocaine
LIDOCAINE HYDROCHLORIDE
Rubicon Research
March 10, 2023ANDA216957 Clindamycin
CLINDAMYCIN HYDROCHLORIDE
Glenmark Pharms Ltd
March 1, 2023NDA209471 Acetaminophen and ibuprofen
COMBOGESIC
Aft Pharms Us
February 23, 2023ANDA215959 Losartan potassium
LOSARTAN POTASSIUM
Granules
February 23, 2023ANDA216759 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Bionpharma
February 3, 2023ANDA213040 Diclofenac
DICLOFENAC SODIUM
Aurolife Pharma LLC
January 5, 2023ANDA215713 Tretinoin
TRETINOIN
Sun Pharma Canada
December 30, 2022ANDA215697 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE
Mankind Pharma
December 21, 2022ANDA211417 Levothyroxine
LEVOTHYROXINE SODIUM
Macleods Pharms
November 28, 2022ANDA216044 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE
Unique
November 23, 2022ANDA215886 Ofloxacin
OFLOXACIN
Mankind Pharma
November 23, 2022ANDA216436 Atorvastatin
ATORVASTATIN CALCIUM
Biocon Pharma
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 27, 2022ANDA216798 Fenofibrate
FENOFIBRATE
Aurobindo Pharma
September 21, 2022ANDA208021 Diclofenac
DICLOFENAC SODIUM
Lupin Pharms
August 11, 2022ANDA210609 Tadalafil
TADALAFIL
Prinston Inc
August 8, 2022ANDA215604 Dexamethasone
DEXAMETHASONE
Novitium Pharma
July 27, 2022ANDA212351 Diclofenac
DICLOFENAC SODIUM
Alembic
July 13, 2022ANDA214181 Nystatin and triamcinolone acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Macleods Pharms
July 7, 2022ANDA213273 Enalapril maleate
ENALAPRIL MALEATE
Prinston Inc
May 10, 2022ANDA207588 Levothyroxine
LEVOTHYROXINE SODIUM
Watson Labs Teva
May 6, 2022ANDA207714 Diclofenac
DICLOFENAC SODIUM
Apotex
March 28, 2022ANDA215672 Prednisone
PREDNISONE
Aurobindo Pharma Ltd
March 23, 2022ANDA215788 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Pharmazone
March 10, 2022ANDA214346 Nystatin
NYSTATIN
Pharmazone
March 7, 2022ANDA214443 Allopurinol
ALLOPURINOL
Harman Finochem
February 25, 2022ANDA214643 Divalproex sodium
DIVALPROEX SODIUM
Unichem
February 23, 2022ANDA216211 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Rubicon Research
February 9, 2022ANDA211320 Chlorthalidone
CHLORTHALIDONE
Adaptis
February 8, 2022ANDA214330 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Novitium Pharma
February 2, 2022ANDA215568 Bupropion
BUPROPION HYDROCHLORIDE
Granules
January 7, 2022ANDA215630 Famotidine
FAMOTIDINE
Vkt Pharma
December 3, 2021ANDA213320 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Harman Finochem
November 4, 2021ANDA215767 Famotidine
FAMOTIDINE
Annora Pharma
October 14, 2021ANDA215106 Dexamethasone
DEXAMETHASONE
Amneal
October 8, 2021ANDA215585 Diclofenac
DICLOFENAC POTASSIUM
Ingenus Pharms LLC
October 1, 2021ANDA214957 Gabapentin
GABAPENTIN
Ascent Pharms Inc
August 10, 2021ANDA213566 Nystatin
NYSTATIN
Macleods Pharms
August 3, 2021ANDA211890 Ibuprofen and famotidine
IBUPROFEN AND FAMOTIDINE
Alkem Labs Ltd
July 27, 2021ANDA212482 Lidocaine and prilocaine
LIDOCAINE AND PRILOCAINE
Padagis Us
July 13, 2021ANDA214099 Baclofen
BACLOFEN
Aurobindo Pharma Ltd
June 1, 2021ANDA207085 Albuterol sulfate
ALBUTEROL SULFATE
Sandoz
May 20, 2021ANDA212443 Ketoconazole
KETOCONAZOLE
Encube
May 19, 2021ANDA214548 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE
Unichem
May 10, 2021ANDA214956 Gabapentin
GABAPENTIN
Ascent Pharms Inc
March 19, 2021ANDA213486 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Graviti Pharms
March 11, 2021ANDA212438 Clindamycin
CLINDAMYCIN PHOSPHATE
Encube
March 5, 2021ANDA214374 Baclofen
BACLOFEN
Rising
February 19, 2021ANDA210220 Cefdinir
CEFDINIR
Alkem Labs Ltd
February 19, 2021ANDA210534 Cefdinir
CEFDINIR
Alkem Labs Ltd
February 11, 2021ANDA208412 Prednisone
PREDNISONE
Strides Pharma
January 13, 2021ANDA214603 Gemfibrozil
GEMFIBROZIL
Ascent Pharms Inc
December 17, 2020ANDA203433 Fluticasone propionate and salmeterol
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Hikma
December 3, 2020ANDA205129 Celecoxib
CELECOXIB
Sciegen Pharms
November 27, 2020ANDA214129 Chlorthalidone
CHLORTHALIDONE
Ajanta Pharma Ltd
November 25, 2020ANDA213302 Atenolol and chlorthalidone
ATENOLOL AND CHLORTHALIDONE
Unichem
November 18, 2020ANDA213859 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Guangzhou Novaken
October 21, 2020ANDA214452 Potassium chloride
POTASSIUM CHLORIDE
Granules
October 19, 2020ANDA212399 Levothyroxine
LEVOTHYROXINE SODIUM
Accord Hlthcare
October 2, 2020ANDA212949 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
Cspc Ouyi
August 28, 2020ANDA212982 Clobetasol propionate
CLOBETASOL PROPIONATE
Encube
August 25, 2020ANDA209302 Sildenafil
SILDENAFIL CITRATE
Umedica
August 24, 2020ANDA206463 Lidocaine
LIDOCAINE
Amneal
August 24, 2020ANDA209954 Albuterol sulfate
ALBUTEROL SULFATE
Lupin
August 12, 2020ANDA213967 Methocarbamol
METHOCARBAMOL
Aurobindo Pharma Ltd
July 9, 2020ANDA212067 Baclofen
BACLOFEN
Unichem
July 6, 2020ANDA213324 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Unichem
June 12, 2020ANDA213864 Fenofibrate
FENOFIBRATE
Mankind Pharma
May 27, 2020ANDA212784 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Ajanta Pharma Ltd
May 27, 2020ANDA213798 Tizanidine
TIZANIDINE HYDROCHLORIDE
Rubicon Research
May 20, 2020ANDA212544 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Msn
May 8, 2020ANDA212289 Azelastine hydrochloride
AZELASTINE HYDROCHLORIDE
Aurobindo Pharma Ltd
May 8, 2020ANDA213794 Ibuprofen
IBUPROFEN
Aurobindo Pharma Ltd
April 15, 2020ANDA207798 Carbamazepine
CARBAMAZEPINE
Umedica
April 8, 2020ANDA209959 Albuterol sulfate
ALBUTEROL SULFATE
Cipla
March 18, 2020ANDA209553 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE
Yiling
February 21, 2020ANDA212517 Naproxen
NAPROXEN
Sciegen Pharms
February 20, 2020ANDA213413 Diphenoxylate hydrochloride and atropine sulfate
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Leading
February 18, 2020ANDA204206 Naproxen and esomeprazole magnesium
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
DR Reddys
February 11, 2020ANDA213412 Chlorthalidone
CHLORTHALIDONE
Alkem Labs Ltd
January 27, 2020ANDA210986 Diclofenac
DICLOFENAC SODIUM
Encube
November 21, 2019ANDA213136 Atenolol
ATENOLOL
Unichem
November 15, 2019ANDA211295 Clobetasol propionate
CLOBETASOL PROPIONATE
Encube
November 14, 2019ANDA210907 Buspirone
BUSPIRONE HYDROCHLORIDE
Unichem
October 30, 2019ANDA212199 Naproxen
NAPROXEN SODIUM
Sciegen Pharms
October 18, 2019ANDA209286 Divalproex sodium
DIVALPROEX SODIUM
Lupin
October 8, 2019ANDA206912 Pregabalin
PREGABALIN
Hetero Labs Ltd III
October 7, 2019ANDA209366 Acyclovir
ACYCLOVIR
Adaptis
October 7, 2019ANDA209402 Doxycycline
DOXYCYCLINE HYCLATE
Changzhou Pharm
September 6, 2019ANDA212197 Albuterol sulfate
ALBUTEROL SULFATE
Quagen
August 9, 2019ANDA211825 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Unichem
August 6, 2019ANDA211627 Chlorthalidone
CHLORTHALIDONE
Unichem
July 24, 2019ANDA212557 Nystatin
NYSTATIN
Torrent
July 19, 2019ANDA207799 Pregabalin
PREGABALIN
Alkem Labs Ltd
July 19, 2019ANDA208677 Pregabalin
PREGABALIN
Sciegen Pharms
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
April 24, 2019ANDA206381 Rosuvastatin
ROSUVASTATIN CALCIUM
Sciegen Pharms
April 17, 2019ANDA208250 Azithromycin
AZITHROMYCIN
Cspc Ouyi
April 9, 2019ANDA207626 Rosuvastatin
ROSUVASTATIN CALCIUM
Umedica
April 5, 2019ANDA203410 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Micro Labs Ltd India
April 3, 2019ANDA211303 Permethrin
PERMETHRIN
Encube Ethicals
March 27, 2019ANDA212196 Tizanidine
TIZANIDINE HYDROCHLORIDE
Alkem Labs Ltd
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 26, 2019ANDA211839 Tadalafil
TADALAFIL
Torrent
March 15, 2019ANDA205974 Acyclovir
ACYCLOVIR
Zydus Lifesciences
March 12, 2019ANDA210267 Tizanidine
TIZANIDINE HYDROCHLORIDE
Ingenus Pharms LLC
March 12, 2019ANDA210614 Nifedipine
NIFEDIPINE
Novast Labs
March 12, 2019ANDA211820 Allopurinol
ALLOPURINOL
Unichem
March 8, 2019ANDA211064 Folic acid
FOLIC ACID
Rising
February 22, 2019ANDA211518 Benzonatate
BENZONATATE
Ascent Pharms Inc
February 21, 2019ANDA207105 Aripiprazole
ARIPIPRAZOLE
Alkem Labs Ltd
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
January 4, 2019ANDA203379 Glyburide
GLYBURIDE
Cadila Pharms Ltd
December 19, 2018ANDA206948 Benzonatate
BENZONATATE
Puracap Pharm LLC
December 19, 2018ANDA207206 Metoprolol
METOPROLOL SUCCINATE
Visum Pharm
December 19, 2018ANDA210921 Potassium chloride
POTASSIUM CHLORIDE
Aurobindo Pharma
December 7, 2018ANDA204276 Ergocalciferol
ERGOCALCIFEROL
Puracap Pharm LLC
November 23, 2018ANDA211469 Lidocaine
LIDOCAINE
Alembic
November 23, 2018ANDA211542 Temazepam
TEMAZEPAM
Alembic
November 9, 2018ANDA210897 Budesonide
BUDESONIDE
Lupin
October 31, 2018ANDA209587 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Lgm Pharma
October 31, 2018ANDA210497 Bupropion
BUPROPION HYDROCHLORIDE
Accord Hlthcare
October 26, 2018ANDA207465 Metoprolol
METOPROLOL SUCCINATE
Cipla
October 26, 2018ANDA211285 Progesterone
PROGESTERONE
Eugia Pharma
October 25, 2018ANDA208249 Azithromycin
AZITHROMYCIN
Cspc Ouyi
October 12, 2018ANDA206401 Sildenafil
SILDENAFIL CITRATE
Ajanta Pharma Ltd
October 3, 2018ANDA210971 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE
Novitium Pharma
September 26, 2018ANDA211106 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Abhai LLC
August 27, 2018ANDA209882 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Laurus
July 31, 2018ANDA211147 Azithromycin
AZITHROMYCIN
Zydus Lifesciences
July 16, 2018ANDA208767 Clindamycin
CLINDAMYCIN PHOSPHATE
Zydus Lifesciences
July 5, 2018ANDA207370 Azithromycin
AZITHROMYCIN
Aurobindo Pharma Ltd
July 5, 2018ANDA207398 Azithromycin
AZITHROMYCIN
Aurobindo Pharma Ltd
June 22, 2018ANDA208921 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE
Pharmobedient
June 18, 2018ANDA209912 Atorvastatin
ATORVASTATIN CALCIUM
Graviti Pharms
June 11, 2018ANDA091448 Sildenafil
SILDENAFIL CITRATE
Torrent
June 11, 2018ANDA202659 Sildenafil
SILDENAFIL CITRATE
Hetero Labs Ltd V
June 8, 2018ANDA209421 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Strides Pharma
June 7, 2018ANDA208834 Etodolac
ETODOLAC
Amneal Pharms Co
May 31, 2018ANDA208205 Nystatin and triamcinolone acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Lupin
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
April 24, 2018ANDA208644 Rabeprazole sodium
RABEPRAZOLE SODIUM
Alkem Labs Ltd
April 9, 2018ANDA207531 Azithromycin
AZITHROMYCIN
Epic Pharma LLC
March 7, 2018ANDA210401 Acyclovir
ACYCLOVIR
Pharmobedient
March 6, 2018ANDA206069 Armodafinil
ARMODAFINIL
Aurobindo Pharma Ltd
January 23, 2018ANDA210071 Celecoxib
CELECOXIB
Cspc Ouyi
January 9, 2018ANDA208348 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Lupin
December 22, 2017ANDA203572 Lorazepam
LORAZEPAM
Aurobindo Pharma
December 22, 2017ANDA209335 Oxybutynin
OXYBUTYNIN CHLORIDE
Abhai LLC
November 22, 2017ANDA208898 Rosuvastatin
ROSUVASTATIN CALCIUM
Msn
November 16, 2017ANDA205710 Budesonide
BUDESONIDE
Cipla
November 6, 2017ANDA204901 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Prinston Inc
October 10, 2017ANDA205253 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE
Zydus Pharms
September 18, 2017ANDA208848 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Encube
September 14, 2017ANDA209113 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Zydus Pharms
August 31, 2017ANDA207466 Metaxalone
METAXALONE
Sciegen Pharms
August 30, 2017ANDA205868 Lansoprazole
LANSOPRAZOLE
Adaptis
August 16, 2017ANDA207196 Modafinil
MODAFINIL
Appco
July 21, 2017ANDA207857 Albuterol sulfate
ALBUTEROL SULFATE
Sun Pharm
June 28, 2017ANDA207444 Tobramycin
TOBRAMYCIN
Somerset Theraps LLC
May 31, 2017ANDA208170 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Rubicon Research
May 5, 2017ANDA206173 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Cadila Pharms Ltd
May 3, 2017ANDA207882 Telmisartan
TELMISARTAN
Prinston Inc
April 12, 2017ANDA207479 Bupropion
BUPROPION HYDROCHLORIDE
Sciegen Pharms
February 24, 2017ANDA208578 Oseltamivir phosphate
OSELTAMIVIR PHOSPHATE
Zydus Pharms
February 16, 2017ANDA208963 Fluconazole
FLUCONAZOLE
Zydus Pharms
February 8, 2017ANDA203550 Methocarbamol
METHOCARBAMOL
Pharmobedient
January 24, 2017ANDA204170 Zolpidem tartrate
ZOLPIDEM TARTRATE
Sun Pharm
January 12, 2017ANDA205592 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Cosette Pharms Nc
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 29, 2016ANDA204720 Glipizide
GLIPIZIDE
Unique
December 20, 2016ANDA203559 Prednisolone
PREDNISOLONE SODIUM PHOSPHATE
Edenbridge Pharms
November 23, 2016ANDA202413 Ibuprofen
IBUPROFEN
Shandong Xinhua
November 22, 2016ANDA204770 Metaxalone
METAXALONE
Lannett Co Inc
November 16, 2016ANDA206560 Metronidazole
METRONIDAZOLE
Cadila
October 31, 2016ANDA207616 Rosuvastatin
ROSUVASTATIN CALCIUM
Hetero Labs Ltd V
September 15, 2016ANDA208451 Eszopiclone
ESZOPICLONE
Aurobindo Pharma
September 13, 2016ANDA208301 Diclofenac
DICLOFENAC SODIUM
Glenmark Pharms Ltd
September 12, 2016ANDA206174 Aripiprazole
ARIPIPRAZOLE
Ajanta Pharma Ltd
September 9, 2016ANDA206498 Lidocaine
LIDOCAINE
Glenmark Pharms Ltd
September 2, 2016ANDA206116 Diclofenac
DICLOFENAC SODIUM
Amneal Pharms
July 28, 2016ANDA204467 Allopurinol
ALLOPURINOL
Regcon Holdings
July 25, 2016ANDA203203 Lansoprazole
LANSOPRAZOLE
Xiromed
July 19, 2016ANDA079172 Rosuvastatin
ROSUVASTATIN CALCIUM
Glenmark Speclt
July 12, 2016ANDA204598 Fenofibrate
FENOFIBRATE
Hetero Labs Ltd III
April 28, 2016ANDA206298 Diclofenac
DICLOFENAC SODIUM
Sun Pharma Canada
March 16, 2016ANDA204590 Celecoxib
CELECOXIB
Macleods Pharms
March 1, 2016ANDA205794 Bupropion
BUPROPION HYDROCHLORIDE
Sciegen Pharms
February 18, 2016ANDA204989 Gabapentin
RELGAABI
Sciegen Pharms
February 4, 2016ANDA205101 Gabapentin
GABAPENTIN
Sciegen Pharms
January 11, 2016ANDA205564 Levocetirizine dihydrochloride
LEVOCETIRIZINE DIHYDROCHLORIDE
Macleods Pharms
November 30, 2015ANDA206528 Memantine hydrochloride
MEMANTINE HYDROCHLORIDE
Ajanta Pharma Ltd
November 18, 2015ANDA204237 Rabeprazole sodium
RABEPRAZOLE SODIUM
Rubicon Research
October 30, 2015ANDA205150 Telmisartan
TELMISARTAN
Adaptis
October 8, 2015ANDA204290 Montelukast
MONTELUKAST SODIUM
Unichem
September 25, 2015ANDA078279 Esomeprazole
ESOMEPRAZOLE MAGNESIUM
DR Reddys
August 28, 2015ANDA078032 Escitalopram
ESCITALOPRAM OXALATE
Prinston Inc
August 20, 2015ANDA204132 Diclofenac
DICLOFENAC SODIUM
Lupin
August 12, 2015ANDA203835 Losartan potassium
LOSARTAN POTASSIUM
Hetero Labs Ltd V
August 7, 2015ANDA206297 Lidocaine
LIDOCAINE
Amneal Pharms
July 31, 2015ANDA203346 Alprazolam
ALPRAZOLAM
Aurobindo Pharma
June 29, 2015ANDA204003 Desvenlafaxine
DESVENLAFAXINE SUCCINATE
Alembic
June 29, 2015ANDA204028 Desvenlafaxine
DESVENLAFAXINE SUCCINATE
Rubicon Research
June 29, 2015ANDA204172 Desvenlafaxine
DESVENLAFAXINE SUCCINATE
Lupin
May 22, 2015ANDA204093 Montelukast
MONTELUKAST SODIUM
Hetero Labs Ltd V
April 28, 2015ANDA201519 Aripiprazole
ARIPIPRAZOLE
Torrent
April 28, 2015ANDA202101 Aripiprazole
ARIPIPRAZOLE
Alembic
March 16, 2015ANDA204597 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Sciegen Pharms
January 30, 2015ANDA202929 Eszopiclone
ESZOPICLONE
Macleods Pharms
January 8, 2015ANDA202801 Levofloxacin
LEVOFLOXACIN
Hetero Labs Ltd V
December 5, 2014ANDA205019 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Nuvo Pharm
November 26, 2014ANDA203818 Diclofenac
DICLOFENAC SODIUM
Sun Pharma Canada
October 31, 2014ANDA091672 Omeprazole
OMEPRAZOLE
Glenmark Pharms Ltd
October 31, 2014ANDA203854 Paroxetine
PAROXETINE
Prinston Inc
October 28, 2014ANDA200981 Metoprolol
METOPROLOL TARTRATE
Rubicon Research
September 25, 2014ANDA205008 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE
Nuvo Pharm
September 15, 2014ANDA204165 Clopidogrel
CLOPIDOGREL BISULFATE
Sciegen Pharms
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 20, 2014ANDA204279 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE
Heritage
August 15, 2014ANDA202862 Olanzapine
OLANZAPINE
Macleods Pharms Ltd
July 7, 2014ANDA090032 Telmisartan
TELMISARTAN
Glenmark Pharms Ltd
June 11, 2014ANDA203088 Duloxetine
DULOXETINE HYDROCHLORIDE
Breckenridge
April 15, 2014ANDA091166 Eszopiclone
ESZOPICLONE
Glenmark Pharms Ltd
January 27, 2014ANDA202437 Folic acid
FOLIC ACID
Cadila Pharms Ltd
January 22, 2014ANDA203458 Metronidazole
METRONIDAZOLE
Unichem
December 11, 2013ANDA090694 Duloxetine
DULOXETINE HYDROCHLORIDE
Lupin
November 8, 2013ANDA202376 Rabeprazole sodium
RABEPRAZOLE SODIUM
Torrent
November 5, 2013ANDA203687 Finasteride
FINASTERIDE
Aurobindo Pharma Ltd
October 29, 2013ANDA203834 Acyclovir
ACYCLOVIR
Hetero Labs Ltd V
October 21, 2013ANDA203245 Amlodipine
AMLODIPINE BESYLATE
Unichem
October 11, 2013ANDA090549 Penicillin v potassium
PENICILLIN V POTASSIUM
Hikma Pharms
September 11, 2013ANDA078970 Zolpidem tartrate
ZOLPIDEM TARTRATE
Lupin
September 11, 2013ANDA203769 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Sciegen Pharms
August 16, 2013ANDA200900 Progesterone
PROGESTERONE
Bionpharma
June 3, 2013ANDA201507 Hydroxyzine
HYDROXYZINE PAMOATE
Heritage Pharma
May 6, 2013ANDA203154 Allopurinol
ALLOPURINOL
Accord Hlthcare
April 30, 2013ANDA202433 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE
Aurobindo Pharma Ltd
April 17, 2013ANDA202112 Glimepiride
GLIMEPIRIDE
Regcon Holdings
March 4, 2013ANDA202202 Warfarin sodium
WARFARIN SODIUM
Amneal Pharms
February 13, 2013ANDA200268 Pioglitazone
PIOGLITAZONE HYDROCHLORIDE
Aurobindo Pharma Ltd
February 12, 2013ANDA201504 Quetiapine
QUETIAPINE FUMARATE
Alkem Labs Ltd
February 6, 2013ANDA202467 Pioglitazone
PIOGLITAZONE HYDROCHLORIDE
Macleods Pharms Ltd
January 31, 2013ANDA091281 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Twi Pharms Inc
November 29, 2012ANDA200295 Liothyronine sodium
LIOTHYRONINE SODIUM
Sigmapharm Labs LLC
November 28, 2012ANDA091283 Tizanidine
TIZANIDINE HYDROCHLORIDE
Unichem Labs Ltd
October 1, 2012ANDA201336 Fluoxetine
FLUOXETINE HYDROCHLORIDE
Heritage
September 27, 2012ANDA202910 Irbesartan
IRBESARTAN
Hetero Labs Ltd V
September 26, 2012ANDA078963 Modafinil
MODAFINIL
Orbion Pharms
September 17, 2012ANDA202640 Meclizine hydrochloride
MECLIZINE HYDROCHLORIDE
Aurobindo Pharma USA
September 11, 2012ANDA078777 Escitalopram
ESCITALOPRAM OXALATE
Graviti Pharms
September 11, 2012ANDA090939 Escitalopram
ESCITALOPRAM OXALATE
Torrent Pharms Ltd
September 7, 2012ANDA077652 Levofloxacin
LEVOFLOXACIN
Zydus Lifesciences
September 5, 2012ANDA202239 Amlodipine besylate and benazepril hydrochloride
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Aurobindo Pharma Ltd
August 3, 2012ANDA201515 Montelukast
MONTELUKAST SODIUM
Torrent Pharms Ltd
July 31, 2012ANDA078404 Budesonide
BUDESONIDE
Impax Labs Inc
July 25, 2012ANDA065489 Clarithromycin
CLARITHROMYCIN
Aurobindo
June 29, 2012ANDA202759 Glimepiride
GLIMEPIRIDE
Aurobindo Pharma Ltd
May 30, 2012ANDA202230 Losartan potassium
LOSARTAN POTASSIUM
Macleods Pharms Ltd
April 23, 2012ANDA076255 Olanzapine
OLANZAPINE
DR Reddys Labs Ltd
March 27, 2012ANDA091388 Quetiapine
QUETIAPINE FUMARATE
Aurobindo Pharma Ltd
March 27, 2012ANDA201109 Quetiapine
QUETIAPINE FUMARATE
Lupin Ltd
March 12, 2012ANDA090070 Divalproex sodium
DIVALPROEX SODIUM
Reddys
March 7, 2012ANDA202068 Methimazole
METHIMAZOLE
Rising
January 20, 2012ANDA091568 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Aurobindo Pharma Ltd
January 20, 2012ANDA091569 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Aurobindo Pharma Ltd
January 18, 2012ANDA201991 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Adaptis
December 23, 2011ANDA090856 Fenofibrate
FENOFIBRATE
Lupin Ltd
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 6, 2011ANDA091368 Clonidine
CLONIDINE HYDROCHLORIDE
Alembic Pharms Ltd
October 6, 2011ANDA090170 Lamotrigine
LAMOTRIGINE
Unichem Labs Ltd
August 29, 2011ANDA200503 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Lupin Ltd
August 3, 2011ANDA090700 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Glenmark Pharms Ltd
July 21, 2011ANDA090007 Gabapentin
GABAPENTIN
Pharmazone
June 29, 2011ANDA090692 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Lupin Ltd
June 8, 2011ANDA090480 Mupirocin
MUPIROCIN
Glenmark Pharms
June 6, 2011ANDA091497 Losartan potassium
LOSARTAN POTASSIUM
Prinston Inc
May 31, 2011ANDA078662 Donepezil hydrochloride
DONEPEZIL HYDROCHLORIDE
Strides Pharma
May 31, 2011ANDA090056 Donepezil hydrochloride
DONEPEZIL HYDROCHLORIDE
Aurobindo
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
January 19, 2011ANDA077619 Pantoprazole sodium
PANTOPRAZOLE SODIUM
DR Reddys Labs Ltd
December 22, 2010ANDA091276 Indomethacin
INDOMETHACIN
Glenmark Pharms Ltd
December 20, 2010ANDA090836 Cephalexin
CEPHALEXIN
Alkem Labs Ltd
December 14, 2010ANDA091491 Levetiracetam
LEVETIRACETAM
Zhejiang Jingxin
December 1, 2010ANDA090066 Diclofenac
DICLOFENAC SODIUM
Unique
October 15, 2010ANDA091269 Lansoprazole
LANSOPRAZOLE
DR Reddys Labs Ltd
October 8, 2010ANDA090515 Levetiracetam
LEVETIRACETAM
Hetero Labs Ltd III
October 6, 2010ANDA078243 Losartan potassium
LOSARTAN POTASSIUM
Zydus Pharms USA Inc
October 6, 2010ANDA091629 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Aurobindo Pharma
August 31, 2010ANDA091042 Phendimetrazine tartrate
PHENDIMETRAZINE TARTRATE
Kvk Tech
August 20, 2010ANDA040879 Hydrocortisone
HYDROCORTISONE
Rising
August 3, 2010ANDA090455 Ergocalciferol
ERGOCALCIFEROL
Onesource
July 1, 2010ANDA040771 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Rising
June 7, 2010ANDA090061 Finasteride
FINASTERIDE
Hetero Labs Ltd III
May 24, 2010ANDA090682 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE
Aurobindo Pharma
May 21, 2010ANDA078245 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Lupin Ltd
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, 2010ANDA078414 Amlodipine
AMLODIPINE BESYLATE
Oxford Pharms
February 25, 2010ANDA090135 Ropinirole
ROPINIROLE HYDROCHLORIDE
Glenmark Pharms Ltd
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 9, 2009ANDA090485 Tramadol hydrochloride and acetaminophen
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Amneal Pharms
November 10, 2009ANDA090763 Lansoprazole
LANSOPRAZOLE
Mylan Pharms Inc
November 6, 2009ANDA090200 Methocarbamol
METHOCARBAMOL
Hetero Labs Ltd III
September 17, 2009ANDA078906 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Glenmark Pharms Ltd
September 17, 2009ANDA090374 Zaleplon
ZALEPLON
Orbion Pharms
August 26, 2009ANDA078895 Clonidine
CLONIDINE HYDROCHLORIDE
Unichem
August 18, 2009ANDA078635 Bisoprolol fumarate
BISOPROLOL FUMARATE
Unichem
August 10, 2009ANDA078284 Sumatriptan
SUMATRIPTAN SUCCINATE
Orbion Pharms
August 10, 2009ANDA078327 Sumatriptan
SUMATRIPTAN SUCCINATE
Aurobindo Pharma
June 18, 2009ANDA077789 Chlorhexidine gluconate
CHLORHEXIDINE GLUCONATE
Pharmobedient
June 3, 2009ANDA079009 Glyburide and metformin hydrochloride
GLYBURIDE AND METFORMIN HYDROCHLORIDE
Heritage
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 27, 2009ANDA078870 Cetirizine
CETIRIZINE HYDROCHLORIDE
Pharmazone
April 17, 2009ANDA078490 Omeprazole
OMEPRAZOLE
DR Reddys Labs Ltd
March 27, 2009ANDA078235 Topiramate
TOPIRAMATE
Zydus Pharms USA Inc
March 27, 2009ANDA090162 Topiramate
TOPIRAMATE
Unichem Labs Ltd
February 5, 2009ANDA078329 Ibuprofen
IBUPROFEN
Strides Pharma
January 27, 2009ANDA077633 Lamotrigine
LAMOTRIGINE
Zydus Pharms USA
January 15, 2009ANDA078154 Levetiracetam
LEVETIRACETAM
Lupin
December 16, 2008ANDA077839 Albuterol sulfate
ALBUTEROL SULFATE
Ritedose Corp
November 25, 2008ANDA078853 Divalproex sodium
DIVALPROEX SODIUM
Orbion Pharms
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 4, 2008ANDA076768 Alendronate sodium
ALENDRONATE SODIUM
Cipla
July 29, 2008ANDA078597 Divalproex sodium
DIVALPROEX SODIUM
Sun Pharm Inds
June 30, 2008ANDA077568 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE
Fdc Ltd
June 20, 2008ANDA076601 Cetirizine
CETIRIZINE HYDROCHLORIDE
Taro
June 17, 2008ANDA078398 Cetirizine
CETIRIZINE HYDROCHLORIDE
Padagis Us
June 6, 2008ANDA078989 Zaleplon
ZALEPLON
Unichem
June 2, 2008ANDA078955 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE
Ipca Labs Ltd
May 22, 2008ANDA078212 Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE
Aurobindo Pharma
May 12, 2008ANDA078722 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Sun Pharm Inds Ltd
April 17, 2008ANDA078321 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Cspc Ouyi
March 13, 2008ANDA078902 Paroxetine
PAROXETINE HYDROCHLORIDE
Mylan
March 11, 2008ANDA065470 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE
Aurobindo Pharma
January 11, 2008ANDA078069 Oxcarbazepine
OXCARBAZEPINE
Breckenridge Pharm
January 8, 2008ANDA078403 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE
Granules
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 20, 2007NDA021519 Fluvoxamine maleate
LUVOX
Ani Pharms
December 14, 2007ANDA040734 Methimazole
METHIMAZOLE
Heritage Pharma
December 14, 2007ANDA065473 Cefdinir
CEFDINIR
Aurobindo Pharma
November 14, 2007ANDA077870 Glyburide and metformin hydrochloride
GLYBURIDE AND METFORMIN HYDROCHLORIDE
Aurobindo Pharma
November 9, 2007ANDA065373 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Hikma Pharms
November 1, 2007ANDA078296 Lovastatin
LOVASTATIN
Lupin
October 31, 2007ANDA078512 Atenolol
ATENOLOL
Aurobindo Pharma
October 30, 2007ANDA078341 Finasteride
FINASTERIDE
Aurobindo Pharma
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 12, 2007ANDA077538 Fluticasone propionate
FLUTICASONE PROPIONATE
Apotex
September 5, 2007ANDA077614 Carvedilol
CARVEDILOL
Zydus Pharms USA Inc
September 5, 2007ANDA078165 Carvedilol
CARVEDILOL
Rubicon Research
August 17, 2007ANDA077903 Zolpidem tartrate
ZOLPIDEM TARTRATE
Torrent Pharms
August 13, 2007ANDA065358 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Sandoz Inc
July 31, 2007ANDA078539 Ondansetron
ONDANSETRON HYDROCHLORIDE
Aurobindo Pharma
July 12, 2007ANDA078043 Amlodipine
AMLODIPINE BESYLATE
Lupin
July 2, 2007ANDA078297 Terbinafine hydrochloride
TERBINAFINE HYDROCHLORIDE
Aurobindo Pharma
June 27, 2007ANDA078152 Ondansetron
ONDANSETRON
Glenmark Pharms Ltd
June 8, 2007ANDA040597 Benzonatate
BENZONATATE
Zydus Pharms USA
June 8, 2007ANDA077863 Diclofenac
DICLOFENAC SODIUM
Unique
May 29, 2007ANDA065392 Cefadroxil
CEFADROXIL
Lupin
May 11, 2007ANDA077987 Pravastatin sodium
PRAVASTATIN SODIUM
Glenmark Pharms Ltd
May 11, 2007ANDA078103 Simvastatin
SIMVASTATIN
Lupin
May 4, 2007ANDA065332 Cefdinir
CEFDINIR
Teva Pharms
April 26, 2007ANDA077859 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE
Aurobindo Pharma
April 23, 2007ANDA077322 Zolpidem tartrate
ZOLPIDEM TARTRATE
Sandoz
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, 2007ANDA065387 Amoxicillin
AMOXICILLIN
Sandoz
March 16, 2007ANDA040702 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Leading
March 7, 2007ANDA077584 Paroxetine
PAROXETINE HYDROCHLORIDE
Zydus Pharms USA
February 6, 2007ANDA077206 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE
Aurobindo Pharma
February 6, 2007ANDA077670 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE
Lupin
February 1, 2007NDA021777 Cyclobenzaprine hydrochloride
AMRIX
Teva Pharms Intl
January 31, 2007NDA021234 Diclofenac epolamine
FLECTOR
Ibsa
January 25, 2007ANDA065352 Cefadroxil
CEFADROXIL
Aurobindo Pharma
December 28, 2006ANDA065334 Amoxicillin
AMOXICILLIN
Aurobindo
December 20, 2006ANDA077927 Meloxicam
MELOXICAM
Unichem
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
August 29, 2006ANDA040750 Spironolactone
SPIRONOLACTONE
Oxford Pharms
August 11, 2006ANDA076465 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE
Heritage
July 19, 2006ANDA077921 Meloxicam
MELOXICAM
Zydus Pharms USA
July 6, 2006ANDA065246 Azithromycin
AZITHROMYCIN
Pliva
June 28, 2006ANDA077856 Clonazepam
CLONAZEPAM
Prinston Inc
June 19, 2006ANDA065322 Amoxicillin
AMOXICILLIN
Hikma
June 19, 2006ANDA065325 Amoxicillin
AMOXICILLIN
Hikma
May 31, 2006ANDA065259 Cefdinir
CEFDINIR
Lupin
May 22, 2006ANDA077447 Mometasone furoate
MOMETASONE FUROATE
Cosette Pharms Nc
May 19, 2006ANDA065264 Cefdinir
CEFDINIR
Lupin
April 24, 2006ANDA076056 Pravastatin sodium
PRAVASTATIN SODIUM
Aurobindo Pharma USA
April 19, 2006ANDA077563 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE
Jubilant Cadista
March 29, 2006ANDA065255 Amoxicillin
AMOXICILLIN
Hikma
March 29, 2006ANDA065308 Cefuroxime axetil
CEFUROXIME AXETIL
Aurobindo Pharma
March 17, 2006ANDA077634 Zonisamide
ZONISAMIDE
Sun Pharm Inds (In)
February 22, 2006ANDA076504 Fluticasone propionate
FLUTICASONE PROPIONATE
Hikma
January 17, 2006ANDA076143 Bupropion
BUPROPION HYDROCHLORIDE
Apotex
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 9, 2005ANDA065256 Amoxicillin
AMOXICILLIN
Aurobindo
November 9, 2005ANDA065271 Amoxicillin
AMOXICILLIN
Aurobindo
November 9, 2005ANDA077293 Furosemide
FUROSEMIDE
Leading
August 17, 2005ANDA065234 Cephalexin
CEPHALEXIN
Lupin
July 13, 2005ANDA065228 Amoxicillin
AMOXICILLIN
Sandoz
April 25, 2005ANDA076913 Prednisolone
PREDNISOLONE SODIUM PHOSPHATE
Pharm Assoc
April 11, 2005ANDA076942 Ketoconazole
KETOCONAZOLE
Cosette Pharms Nc
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 21, 2004ANDA076679 Mometasone furoate
MOMETASONE FUROATE
Sun Pharma Canada
December 20, 2004ANDA075317 Terazosin hydrochloride
TERAZOSIN HYDROCHLORIDE
Jubilant Cadista
October 22, 2004ANDA076921 Mirtazapine
MIRTAZAPINE
Aurobindo
June 23, 2004ANDA076479 Econazole nitrate
ECONAZOLE NITRATE
Padagis Israel
May 14, 2004ANDA076513 Ofloxacin
OFLOXACIN
Apotex Inc
May 14, 2004ANDA076622 Ofloxacin
OFLOXACIN
Bausch and Lomb
May 14, 2004NDA021433 Fluticasone propionate
FLOVENT HFA
Glaxo Grp Ltd
March 16, 2004ANDA076593 Ciprofloxacin
CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE
Aiping Pharm Inc
February 11, 2004ANDA076118 Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE
Prinston Inc
January 16, 2004ANDA076533 Tizanidine
TIZANIDINE HYDROCHLORIDE
Apotex
December 9, 2003ANDA076543 Betamethasone dipropionate
BETAMETHASONE DIPROPIONATE
Sun Pharma Canada
December 9, 2003ANDA076592 Betamethasone dipropionate
BETAMETHASONE DIPROPIONATE
Padagis Israel
November 7, 2003ANDA065123 Mupirocin
MUPIROCIN
Padagis Israel
August 18, 2003ANDA076453 Lidocaine and prilocaine
LIDOCAINE AND PRILOCAINE
Fougera Pharms
January 29, 2003ANDA040489 Methocarbamol
METHOCARBAMOL
Oxford Pharms
January 28, 2003ANDA075757 Omeprazole
OMEPRAZOLE
Sandoz
December 4, 2002ANDA065119 Amoxicillin
AMOXICILLIN
Chartwell Rx
December 3, 2002ANDA076004 Etodolac
ETODOLAC
Apotex
November 26, 2002ANDA076005 Econazole nitrate
ECONAZOLE NITRATE
Sun Pharma Canada
October 29, 2002ANDA065096 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM
Chartwell Rx
October 24, 2002NDA021116 Levothyroxine
THYRO-TABS
Alvogen
July 12, 2002ANDA040256 Prednisone
PREDNISONE
Ph Health
July 3, 2002ANDA076286 Tizanidine
TIZANIDINE HYDROCHLORIDE
DR Reddys Labs Inc
July 1, 2002ANDA076164 Lisinopril
LISINOPRIL
Prinston Inc
July 1, 2002ANDA076230 Lisinopril and hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Prinston Inc
June 25, 2002ANDA075968 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE
Graviti Pharms
June 5, 2002ANDA075991 Lovastatin
LOVASTATIN
Carlsbad
March 18, 2002ANDA076067 Mometasone furoate
MOMETASONE FUROATE
Padagis Us
February 27, 2002ANDA075948 Carbamazepine
CARBAMAZEPINE
Apotex
December 18, 2001ANDA075927 Naproxen
NAPROXEN
Amneal Pharms Ny
November 14, 2001ANDA075682 Ibuprofen
IBUPROFEN
DR Reddys
July 25, 2001ANDA075671 Megestrol acetate
MEGESTROL ACETATE
Strides Pharma Intl
June 13, 2001ANDA075795 Glipizide
GLIPIZIDE
Apotex
May 31, 2001ANDA040419 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Specgx LLC
May 29, 2001ANDA075673 Clotrimazole and betamethasone dipropionate
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Taro
May 7, 2001ANDA075902 Fluvoxamine maleate
FLUVOXAMINE MALEATE
Apotex
April 16, 2001ANDA075718 Famotidine
FAMOTIDINE
DR Reddys Labs Ltd
January 30, 2001ANDA075614 Terazosin hydrochloride
TERAZOSIN HYDROCHLORIDE
Heritage Pharma Avet
October 18, 2000ANDA075580 Doxazosin
DOXAZOSIN MESYLATE
Apotex
October 6, 2000ANDA075468 Clonazepam
CLONAZEPAM
Rubicon Research
July 28, 2000ANDA075667 Terazosin hydrochloride
TERAZOSIN HYDROCHLORIDE
Bionpharma
September 7, 1999ANDA040319 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Aurobindo Pharma USA
June 30, 1999ANDA075008 Fluocinonide
FLUOCINONIDE
Sun Pharma Canada
June 16, 1999ANDA075282 Cromolyn sodium
CROMOLYN SODIUM
Sandoz
March 19, 1999NDA020612 Lidocaine
LIDODERM
Teikoku Pharma USA
February 26, 1999ANDA040230 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE
Lannett
December 29, 1998ANDA040275 Estradiol
ESTRADIOL
Epic Pharma LLC
December 24, 1998ANDA075264 Tretinoin
TRETINOIN
Padagis Us
November 13, 1998ANDA075185 Diclofenac
DICLOFENAC SODIUM
Carlsbad
October 5, 1998ANDA075150 Clonazepam
CLONAZEPAM
Aurobindo Pharma USA
August 6, 1998ANDA075219 Diclofenac
DICLOFENAC POTASSIUM
Teva
June 19, 1998ANDA040284 Orphenadrine citrate
ORPHENADRINE CITRATE
Lupin
March 11, 1998ANDA075074 Etodolac
ETODOLAC
Taro Pharm Inds
February 14, 1997ANDA064120 Polymyxin b sulfate and trimethoprim sulfate
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Bausch and Lomb Inc
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 29, 1996ANDA074580 Clotrimazole
CLOTRIMAZOLE
Sun Pharma Canada
June 17, 1996ANDA074722 Indapamide
INDAPAMIDE
Actavis Elizabeth
March 29, 1996ANDA070848 Sucralfate
SUCRALFATE
Teva
February 13, 1996NDA050720 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AUGMENTIN '875'
Us Antibiotics
September 13, 1995ANDA064135 Neomycin sulfate, polymyxin b sulfate and dexamethasone
DEXASPORIN
Bausch and Lomb Inc
August 29, 1995ANDA074388 Glyburide
GLYBURIDE
Teva
February 27, 1995ANDA074223 Glipizide
GLIPIZIDE
Watson Labs Teva
December 28, 1994ANDA040066 Sulfacetamide sodium
SULFACETAMIDE SODIUM
Bausch and Lomb
November 28, 1994ANDA074378 Glipizide
GLIPIZIDE
Oxford Pharms
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 11, 1994ANDA064048 Gentamicin sulfate
GENTAMICIN SULFATE
Bausch and Lomb Inc
November 29, 1993ANDA064052 Tobramycin
TOBRAMYCIN
Bausch and Lomb Inc
September 23, 1993ANDA073449 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Watson Labs
March 30, 1992ANDA073556 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE
DR Reddys Labs SA
February 14, 1992ANDA073085 Fluocinonide
FLUOCINONIDE
Cosette Pharms Nc
December 31, 1990NDA019992 Ciprofloxacin
CILOXAN
Sandoz
November 14, 1988ANDA071826 Minoxidil
MINOXIDIL
Ph Health
September 30, 1988ANDA089828 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE
Strides Pharma Intl
September 12, 1988ANDA071745 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE
Teva Pharms
August 18, 1988NDA050592 Tobramycin and dexamethasone
TOBRADEX
Sandoz
August 12, 1988ANDA062752 Tetracycline hydrochloride
TETRACYCLINE HYDROCHLORIDE
Chartwell Tetra
April 6, 1988ANDA071972 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE
Impax Labs Inc
April 5, 1988ANDA071881 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Heritage
January 6, 1988ANDA072041 Betamethasone valerate
DERMABET
Sun Pharma Canada
April 21, 1987ANDA071456 Temazepam
TEMAZEPAM
Novel Labs Inc
April 21, 1987ANDA071457 Temazepam
TEMAZEPAM
Novel Labs Inc
February 13, 1987ANDA062702 Cephalexin
CEPHALEXIN
Teva
October 24, 1986ANDA018659 Allopurinol
ALLOPURINOL
Mylan
October 1, 1986ANDA070730 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Sun Pharma Canada
August 4, 1986ANDA070322 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE
Innogenix
July 23, 1986ANDA089424 Spironolactone
SPIRONOLACTONE
Sun Pharm Industries
December 23, 1985NDA018810 Silver sulfadiazine
THERMAZENE
Thepharmanetwork LLC
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
November 9, 1984ANDA088799 Hydrocortisone
HYDROCORTISONE
Taro
March 19, 1984ANDA088042 Triamcinolone acetonide
TRIDERM
Crown Labs
December 22, 1983ANDA062474 Nystatin
NYSTATIN
Heritage
August 31, 1983NDA018861 Betamethasone valerate
BETAMETHASONE VALERATE
Fougera
August 31, 1983NDA018865 Betamethasone valerate
BETAMETHASONE VALERATE
Fougera
April 21, 1983ANDA085025 Hydrocortisone
HYDROCORTISONE
Padagis Us
January 7, 1983NDA018615 Sulfamethoxazole and trimethoprim
SULFATRIM, SULFATRIM PEDIATRIC
Pharm Assoc
February 25, 1982NDA018578 Silver sulfadiazine
SSD, SSD AF
DR Reddys
December 14, 1981ANDA087479 Hydroxyzine
HYDROXYZINE PAMOATE
Sandoz
October 30, 1981NDA018333 Sucralfate
CARAFATE
Abbvie
August 17, 1981ANDA086724 Lidocaine
LIDOCAINE
Sun Pharma Canada
October 16, 1978ANDA080704 Ergocalciferol
VITAMIN D
Bionpharma
March 9, 1978ANDA085692 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Fougera Pharms
January 20, 1978ANDA085182 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Heritage
May 25, 1975NDA060613 Neomycin sulfate, polymyxin b sulfate and hydrocortisone
CASPORYN HC
Casper Pharma LLC
December 24, 1974ANDA061837 Tetracycline hydrochloride
TETRACYCLINE HYDROCHLORIDE
Watson Labs
March 9, 1973ANDA080706 Hydrocortisone
ALA-CORT
Crown Labs
April 21, 1972ANDA080352 Prednisone
PREDNISONE
Hikma
July 31, 1968ANDA060456 Penicillin v potassium
PENICILLIN-VK
Chartwell Rx
February 14, 1957NDA010721 Meclizine hydrochloride
ANTIVERT
Casper Pharma LLC
—ANDA040600 Hydroxyzine—
—ANDA076180 Lisinopril—
—ANDA078220 Baclofen—
—ANDA084613 Dexamethasone—
—ANDA209727 Prednisone—

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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