FDA All Approvals February 2
Post# of 63700
Posted On: 02/10/2014 5:24:13 PM
FDA All Approvals | ||
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| Drug Name and FDA Appl. # | Suppl. # | Active Ingredients | Company | Approval Type | Approval Date |
|---|---|---|---|---|---|
| PEPCID (NDA # 019462) | 038 | FAMOTIDINE | MARATHON PHARMS | Labeling Revision | 02/03/2014 |
| TRUSOPT (NDA # 020408) | 050 | DORZOLAMIDE HYDROCHLORIDE | MERCK | Labeling Revision | 02/03/2014 |
| ELIGARD (NDA # 021379) | 027 | LEUPROLIDE ACETATE | TOLMAR THERAP | Manufacturing Change or Addition | 02/03/2014 |
| LUNESTA (NDA # 021476) | 028 | ESZOPICLONE | SUNOVION PHARMS INC | Labeling Revision | 02/03/2014 |
| MODAFINIL (ANDA # 077667) | 000 | MODAFINIL | APOTEX INC | Approval | 02/03/2014 |
| BIVALIRUDIN (ANDA # 090816) | 000 | BIVALIRUDIN | HOSPIRA INC | Tentative Approval | 02/03/2014 |
| GLYCOPYRROLATE (ANDA # 091182) | 000 | GLYCOPYRROLATE | STASON PHARMS | Approval | 02/03/2014 |
| SELFEMRA (ANDA # 200151) | 000 | FLUOXETINE | TEVA PHARMS USA | Approval | 02/03/2014 |
| LAMIVUDINE AND ZIDOVUDINE (ANDA # 203259) | 000 | LAMIVUDINE; ZIDOVUDINE | HETERO LABS LTD V | Approval | 02/03/2014 |
| PRIMAQUINE PHOSPHATE (ANDA # 203924) | 000 | PRIMAQUINE PHOSPHATE | ALVOGEN INC | Approval | 02/03/2014 |
| EPANED KIT (NDA # 204308) | 001 | ENALAPRIL MALEATE | SILVERGATE PHARMS | Manufacturing Change or Addition | 02/03/2014 |
| SANDOSTATIN (NDA # 019667) | 059 | OCTREOTIDE ACETATE | NOVARTIS | Manufacturing Change or Addition | 02/04/2014 |
| EXTRANEAL (NDA # 021321) | 030 | ICODEXTRIN | BAXTER HLTHCARE | Manufacturing Change or Addition | 02/04/2014 |
| OXYCONTIN (NDA # 022272) | 015 | OXYCODONE HYDROCHLORIDE | PURDUE PHARMA LP | Manufacturing Change or Addition | 02/04/2014 |
| SIMPONI ARIA (BLA # 125433) | 002 | GOLIMUMAB | JANSSEN BIOTECH | Labeling Revision | 02/04/2014 |
| LAMIVUDINE; ZIDOVUDINE (NDA # 204914) | 000 | LAMIVUDINE; ZIDOVUDINE | MYLAN LABS | Tentative Approval | 02/04/2014 |
| PYLERA (NDA # 050786) | 011 | BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE | APTALIS PHARMA US | Manufacturing Change or Addition | 02/05/2014 |
| DOXERCALCIFEROL (ANDA # 200926) | 000 | DOXERCALCIFEROL | SANDOZ | Approval | 02/05/2014 |
| MORPHINE SULFATE (ANDA # 201011) | 000 | MORPHINE SULFATE | CARACO | Approval | 02/05/2014 |
| LEVONORGESTREL AND ETHINYL ESTRADIOL (ANDA # 201108) | 000 | ETHINYL ESTRADIOL; LEVONORGESTREL | HAUPT PHARMA | Approval | 02/05/2014 |
| DISULFIRAM (ANDA # 202652) | 000 | DISULFIRAM | ROXANE | Approval | 02/05/2014 |
| PHENTERMINE HYDROCHLORIDE (ANDA # 202846) | 000 | PHENTERMINE HYDROCHLORIDE | INVAGEN PHARMS | Approval | 02/05/2014 |
| PHENTERMINE HYDROCHLORIDE (ANDA # 202942) | 000 | PHENTERMINE HYDROCHLORIDE | INVAGEN PHARMS | Approval | 02/05/2014 |
| ILEVRO (NDA # 203491) | 003 | NEPAFENAC | ALCON RES LTD | Manufacturing Change or Addition | 02/05/2014 |
| FLUDEOXYGLUCOSE F18 (ANDA # 203935) | 000 | FLUDEOXYGLUCOSE F-18 | WUSM CYCLOTRON | Approval | 02/05/2014 |
| FLUDEOXYGLUCOSE F18 (ANDA # 203946) | 000 | FLUDEOXYGLUCOSE F-18 | ESSENTIAL ISOTOPES | Approval | 02/05/2014 |
| IMURAN (NDA # 016324) | 037 | AZATHIOPRINE | PROMETHEUS LABS | Labeling Revision | 02/06/2014 |
| ANADROL-50 (NDA # 016848) | 023 | OXYMETHOLONE | MEDA PHARMS | Manufacturing Change or Addition | 02/06/2014 |
| IMURAN (NDA # 017391) | 016 | AZATHIOPRINE SODIUM | PROMETHEUS LABS | Labeling Revision | 02/06/2014 |
| CISPLATIN (NDA # 018057) | 082 | CISPLATIN | HQ SPCLT PHARMA | Manufacturing Change or Addition | 02/06/2014 |
| PLATINOL (NDA # 018057) | 082 | CISPLATIN | HQ SPCLT PHARMA | Manufacturing Change or Addition | 02/06/2014 |
| PLATINOL-AQ (NDA # 018057) | 082 | CISPLATIN | HQ SPCLT PHARMA | Manufacturing Change or Addition | 02/06/2014 |
| BUPRENEX (NDA # 018401) | 018 | BUPRENORPHINE HYDROCHLORIDE | RECKITT BENCKISER | Manufacturing Change or Addition | 02/06/2014 |
| ALOXI (NDA # 021372) | 017 | PALONOSETRON HYDROCHLORIDE | HELSINN HLTHCARE | Labeling Revision | 02/06/2014 |
| ARIPIPRAZOLE (ANDA # 078583) | 000 | ARIPIPRAZOLE | APOTEX INC | Tentative Approval | 02/06/2014 |
| PRAMIPEXOLE DIHYDROCHLORIDE (ANDA # 202206) | 000 | PRAMIPEXOLE DIHYDROCHLORIDE | ANCHEN PHARMS | Approval | 02/06/2014 |
| ZELBORAF (NDA # 202429) | 005 | VEMURAFENIB | HOFFMANN LA ROCHE | Labeling Revision | 02/06/2014 |
| RITALIN (NDA # 010187) | 076 | METHYLPHENIDATE HYDROCHLORIDE | NOVARTIS | Manufacturing Change or Addition | 02/07/2014 |
| ETHAMOLIN (NDA # 019357) | 018 | ETHANOLAMINE OLEATE | QOL MEDCL | Manufacturing Change or Addition | 02/07/2014 |
| AGRYLIN (NDA # 020333) | 021 | ANAGRELIDE HYDROCHLORIDE | SHIRE LLC | Labeling Revision | 02/07/2014 |
| VIBATIV (NDA # 022110) | 007 | TELAVANCIN HYDROCHLORIDE | THERAVANCE INC | Labeling Revision | 02/07/2014 |
| OZURDEX (NDA # 022315) | 008 | DEXAMETHASONE | ALLERGAN | Labeling Revision | 02/07/2014 |
| CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER (NDA # 050796) | 018 | CEFTRIAXONE SODIUM | B BRAUN | Manufacturing Change or Addition | 02/07/2014 |
| BUSPIRONE HYDROCHLORIDE (ANDA # 078888) | 000 | BUSPIRONE HYDROCHLORIDE | ZYDUS PHARMS USA INC | Approval | 02/07/2014 |
| VICTRELIS (NDA # 202258) | 013 | BOCEPREVIR | MERCK SHARP DOHME | Labeling Revision | 02/07/2014 |
| ZYTIGA (NDA # 202379) | 008 | ABIRATERONE ACETATE | JANSSEN BIOTECH | Manufacturing Change or Addition | 02/07/2014 |
| ZOLEDRONIC ACID (NDA # 203231) | 001 | ZOLEDRONIC ACID | ACS DOBFAR INFO SA | Manufacturing Change or Addition | 02/07/2014 |
| AMMONIA N 13 (ANDA # 204506) | 000 | AMMONIA N-13 | WA UNIV SCH MED | Approval | 02/07/2014 |
| VIVITROL (NDA # 021897) | 024 | NALTREXONE | ALKERMES | Manufacturing Change or Addition | 02/09/2014 |
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