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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - January 2013

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE TABLETS, 30 MG/2 MG AND 30 MG/4 MG      SANDOZ, INC.DUETACT TABLETS1/4/2013 
2CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE OINTMENT, 0.005%/0.064%       TOLMAR INC.TACLONEX OINTMENT1/14/2013 
3MORPHINE SULFATE EXTENDED-RELEASE CAPSULES USP, 30 MG, 45 MG, 60 MG, 75 MG, 90 MG AND 120 MG  ACTAVIS ELIZABETH, LLCAVINZA EXTENDED-RELEASE CAPSULES1/16/2013 
4FEXOFENADINE HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS, 30 MG       DR. REDDY'S LABORATORIES LIMITEDCHILDREN'S ALLEGRA ALLERGY & ALLEGRA HIVES1/18/2013 
5NAPHAZOLINE HCL & PHENIRAMINE MALEATE OPHTHALMIC SOLUTION US 0.025%/0.3% (OTC)       AKORN INC.VISINE-A OPHTHAMLIC SOLUTION1/24/2013 
6MUPIROCIN CREAM USP, 2%       GLENMARK GENERICS LTD.BACTROBAN CREAM1/24/2013 
7ROSIGLITAZONE MALEATE TABLETS, 2 MG (BASE), 4 MG (BASE) AND 8 MG (BASE)     TEVA PHARMACEUTICALS USA, INC.AVANDIA TABLETS1/25/2013