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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - August 2013

  Generic Drug Name Generic Manufacturer Brand Name Tentative Approval Date Approval Date
1 BUPROPION HYDROBROMIDE EXTENDED-RELEASE TABLETS, 174 MG AND 522 MG       WATSON LABORATORIES, INC. - FLORIDA APLENZIN EXTENDED-RELEASE TABLETS 8/13/2013   
2 NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS, 375 MG/20 MG (BASE) AND 500 MG/20 MG (BASE)       DR. REDDY'S LABORATORIES LIMITED VIMOVO DELAYED-RELEASE TABLETS 8/12/2013   
3 NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/0.05 MG        FAMY CARE LTD. OVCON-50 TABLETS   8/5/2013 
4 GATIFLOXACIN OPHTHALMIC SOLUTION, 0.5%        LUPIN LIMITED ZYMAXID OPHTHALMIC SOLUTION   8/28/2013 
5 DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES 30 MG        MYLAN PHARMACEUTICALS, INC. FOCALIN XR EXTENDED-RELEASE CAPSULES   8/28/2013 
6 ADEFOVIR DIPIVOXIL TABLETS, 10 MG        SIGMAPHARM LABORATORIES, LLC HEPSERA TABLETS   8/29/2013 
7 ADENOSINE INJECTION USP, 3 MG/ML; PACKAGED IN 60 MG/20 ML AND 90 MG/30 ML SINGLE-DOSE VIALS      TEVA PHARMACEUTICALS, USA ADENOSCAN INJECTION   8/29/2013 
8 LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, AMOXICILLIN CAPSULES USP, AND CLARITHROMYCIN TABLETS USP, 30 MG/500 MG/500 MG      TEVA PHARMACEUTICALS USA PREVPAC   8/30/2013 
9 DOXERCALCIFEROL INJECTION, 2 MCG/ML; PACKAGED IN 4 MCG/2 ML SINGLE-USE AMPULES      INNOPHARMA INC. HECTOROL INJECTION   8/30/2013