Drugs

First-Time Generic Drug Approvals - August 2013

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1BUPROPION HYDROBROMIDE EXTENDED-RELEASE TABLETS, 174 MG AND 522 MG      WATSON LABORATORIES, INC. - FLORIDAAPLENZIN EXTENDED-RELEASE TABLETS 
2NAPROXEN AND ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS, 375 MG/20 MG (BASE) AND 500 MG/20 MG (BASE)      DR. REDDY'S LABORATORIES LIMITEDVIMOVO DELAYED-RELEASE TABLETS 
3NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/0.05 MG       FAMY CARE LTD.OVCON-50 TABLETS8/5/2013 
4GATIFLOXACIN OPHTHALMIC SOLUTION, 0.5%       LUPIN LIMITEDZYMAXID OPHTHALMIC SOLUTION8/28/2013 
5DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES 30 MG       MYLAN PHARMACEUTICALS, INC.FOCALIN XR EXTENDED-RELEASE CAPSULES8/28/2013 
6ADEFOVIR DIPIVOXIL TABLETS, 10 MG       SIGMAPHARM LABORATORIES, LLCHEPSERA TABLETS8/29/2013 
7ADENOSINE INJECTION USP, 3 MG/ML; PACKAGED IN 60 MG/20 ML AND 90 MG/30 ML SINGLE-DOSE VIALS     TEVA PHARMACEUTICALS, USAADENOSCAN INJECTION8/29/2013 
8LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, AMOXICILLIN CAPSULES USP, AND CLARITHROMYCIN TABLETS USP, 30 MG/500 MG/500 MG     TEVA PHARMACEUTICALS USAPREVPAC8/30/2013 
9DOXERCALCIFEROL INJECTION, 2 MCG/ML; PACKAGED IN 4 MCG/2 ML SINGLE-USE AMPULES     INNOPHARMA INC.HECTOROL INJECTION8/30/2013 

 

 

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