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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - March 2012

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1FENOFIBRATE CAPSULES, 43 MG AND 130 MG      DR REDDY'S LABORATORIES, S.A.ANTARA CAPSULES3/1/2012 
2ZIPRASIDONE HYDROCHLORIDE CAPSULES, 20 MG (BASE), 40 MG (BASE), 60 MG (BASE) AND 80 MG (BASE)    LUPIN LIMITEDGEODON CAPSULES3/2/2012 
3ZIPRASIDONE HYDROCHLORIDE CAPSULES, 20 MG (BASE), 40 MG (BASE), 60 MG (BASE) AND 80 MG (BASE)    APOTEX INC.GEODON CAPSULES3/2/2012 
4ZIPRASIDONE HYDROCHLORIDE CAPSULES, 20 MG (BASE), 40 MG (BASE), 60 MG (BASE) AND 80- MG (BASE)    DR. REDDY'S LABORATORIES LIMITEDGEODON CAPSULES3/2/2012 
5GLYCOPYRROLATE TABLETS USP, 1.5 MG       NEXGEN PHARMA, INC.ROBINUL FORTE TABLETS3/12/2012 
6ESCITALOPRAM OXALATE ORAL SOLUTION, 5 MG (BASE)/5 ML       AMNEAL PHARMACEUTICALSLEXAPRO ORAL SOLUTION3/14/2012 
7ESCITALOPRAM TABLETS USP, 5 MG, 10 MG AND 20 MG     IVAX PHARMACEUTICALS, INC.LEXAPRO TABLETS3/14/2012 
8IBANDRONATE SODIUM TABLETS, 150 MG (BASE) (ONCE-MONTHLY)      APOTEX INC.BONIVA TABLETS3/19/2012 
9IBANDRONATE SODIUM TABLETS, 150 MG (BASE) (ONCE-MONTHLY)      ORCHID HEALTHCAREBONIVA TABLETS3/19/2012 
10IBANDRONATE SODIUM TABLETS, 150 MG (BASE) (ONCE-MONTHLY)      MYLAN PHARMACEUTICALS, INC.BONIVA TABLETS3/19/2012 
11QUETIAPINE FUMARATE TABLETS, 25 MG (BASE), 50 MG (BASE), 100 MG (BASE), 200 MG (BASE), 300 MG (BASE) AND 400 MG (BASE)  ACCORD HEALTHCARE, INC.SEROQUEL TABLETS3/27/2012 
12QUETIAPINE FUMARATE TABLETS, 25 MG (BASE), 50 MG (BASE), 100 MG (BASE), 200 MG (BASE), 300 MG (BASE) AND 400 MG (BASE)  SUN PHARMA GLOBAL FZESEROQUEL TABLETS3/27/2012 
13QUETIAPINE FUMARATE TABLETS, 25 MG (BASE), 50 MG (BASE), 100 MG (BASE), 150 MG (BASE), 200 MG (BASE), 300 MG (BASE) AND 400 MG (BASE) DR. REDDY'S LABORATORIES, INC.SEROQUEL TALBETS3/27/2012 
14QUETIAPINE FUMARATE TABLETS, 25 MG (BASE), 50 MG (BASE), 100 MG (BASE) 150 MG (BASE), 200 MG (BASE), 300 MG (BASE) AND 400 MG (BASE) AUROBINDO PHARMA LIMITEDSEROQUEL TABLETS3/27/2012 
15QUETIAPINE FUMARATE TABLETS, 25 MG (BASE), 50 MG (BASE), 100 MG (BASE), 200 MG (BASE), 300 MG (BASE) AND 400 MG (BASE)  APOTEX INC.SEROQUEL TABLETS3/27/2012 
16QUETIAPINE FUMARATE TABLETS, 25 MG (BASE), 50 MG (BASE), 100 MG (BASE), 150 MG (BASE), 200 MG (BASE), 300 MG (BASE) AND 400 MG (BASE) TEVA PHARMACEUTICALS USASEROQUEL TABLETS3/27/2012 
17QUETIAPINE FUMARATE TABLETS, 25 MG (BASE)       ROXANE LABORATORIES, INC.SEROQUEL TABLETS3/27/2012 
18QUETIAPINE FUMARATE TABLETS, 50 MG (BASE), 100 MG (BASE), 200 MG (BASE), 300 MG (BASE) AND 400 MG (BASE)   ROXANE LABORATORIES, INC.SEROQUEL TABLETS3/27/2012 
19QUETIAPINE FUMARATE TABLETS, 25 MG (BASE), 50 MG (BASE), 100 MG (BASE), 200 MG (BASE), 300 MG (BASE) AND 400 MG (BASE)  TORRENT PHARMACEUTICALS, INC.SEROQUEL TABLETS3/27/2012 
20QUETIAPINE FUMARATE TABLETS, 25 MG (BASE), 50 MG (BASE), 100 MG (BASE), 200 MG (BASE), 300 MG (BASE) AND 400 MG (BASE)  LUPIN LIMITEDSEROQUEL TABLETS3/27/2012 
21QUETIAPINE FUMARATE TABLETS, 25 MG (BASE)       MYLAN PHARMACEUTICALS, INC.SEROQUEL TABLETS3/27/2012 
22IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP, 150 MG/12.5 MG, 300 MG/12.5 MG AND 300 MG/25 MG     TEVA PHARMACEUTICALS USAAVALIDE TABLETS3/30/2012 
23IRBESARTAN TABLETS USP, 75 MG, 150 MG AND 300 MG     TEVA PHARMACEUTICALS USAAVAPRO TABLETS3/30/2012