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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - October 2011

  Generic Drug Name Generic Manufacturer Brand Name Approval Date
1 FLUOCINOLONE ACETONIDE TOPICAL OIL (EAR DROPS), 0.01%        IDENTI PHARMACEUTICALS, INC. DERMOTIC EAR DROPS, 0.01% 10/17/2011 
2 FLUOCINOLONE ACETONIDE TOPICAL OIL (BODY OIL), 0.01%        IDENTI PHARMACEUTICALS, INC. DERMA-SMOOTHE/ FS TOPICAL OIL (BODY OIL) 10/17/2011 
3 DIETHYLPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 75 MG        LANNETT COMPANY, INC. TENUATE DOSPAN, 75 MG TABLETS 10/24/2011 
4 OLANZAPINE TABLETS USP, 2.5 MG, 5 MG, 7.5 MG, 10 MG AND 15 MG    TEVA PHARMACEUTICALS USA ZYPREXA TABLETS 10/24/2011 
5 OLANZAPINE FOR INJECTION, 10 MG/SINGLE-USE VIAL        INNOPHARMA LLC ZYPREXA IM INJECTION 10/24/2011 
6 OLANZAPINE ORALLY DISINTEGRATING TABLETS, 5 MG, 10 MG, 15 MG AND 20 MG     PAR PHARMACEUTICAL, INC. ZYPREXA ZYDUS ODT 10/24/2011 
7 OLANZAPINE ORALLY DISINTEGRATING TALBETS, 5 MG, 10 MG, 15 MG AND 20 MG     DR. REDDY'S LABORATORIES LIMITED ZYPREXA ZYDUS 10/24/2011 
8 OLANZAPINE TABLETS USP, 20 MG        DR. REDDY'S LABORATORIES LIMITED ZYPREXA TABLETS 10/24/2011 
9 OLANZAPINE ORALLY DISINTEGRATING TABLETS, 5 MG, 10 MG, 15 MG AND 20 MG     APOTEX INC. ZYPREXA ZYDIS 10/24/2011 
10 MEMANTINE HYDROCHLORIDE TABLETS, 5 MG AND 10 MG       TEVA PHARMACEUTICALS USA NAMENDA TABLETS 10/25/2011 
11 LEVONORGESTREL & ETHINYL ESTRADIOL TABLETS AND ETHINYL ESTR 0.1 MG/0.02 MG; 0.01 MG        WATSON LABORATORIES, INC. LE SEASONIQUE TABLETS 10/25/2011 
12 LEVONORGESTREL & ETHINYL ESTRADIOL USP AND ETHINYL ESTRADIOL 0.1 MG/0.02 MG AND 0.01 MG        LUPIN LIMITED LOSEASONIQUE TABLETS 10/26/2011 
13 CROMOLYN SODIUM ORAL SOLUTION (CONCENTRATE), 100 MG/5 ML        PACK PHARMACEUTICALS LLC GASTROCROM ORAL CONCENTRATE 10/27/2011 
14 EPINASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.05%        PHARMAFORCE INC. ELESTAT OPHTHALMIC SOLUTION 10/31/2011