FDA All Approvals February

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FDA All Approvals
February 2014


This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs * during the selected month. It includes tentative approvals and original approvals.  Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. * Not all biologics are in Drugs@FDA.

This report was produced on February 10, 2014.

Click on a column header to re-sort the table.
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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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