Drugs

First-Time Generic Drug Approvals - January 2013

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

 

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