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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - November 2012

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1SILDENAFIL TABLETS, 20 MG       TORRENT PHARMACEUTICALS LIMITEDREVATIO TABLETS11/6/2012 
2SILDENAFIL TABLETS, 20 MG       APOTEX INC.REVATIO TABLETS11/6/2012 
3SILDENAFIL TABLETS, 20 MG       WATSON LABORATORIES, INC.REVATIO TABLETS11/6/2012 
4SILDENAFIL TABLETS, 20 MG       DR. REDDY'S LABORATORIES, INC.REVATIO TABLETS11/6/2012 
5ACETYLCYSTEINE INJECTION, 200 MG/ML; PACKAGED IN 6 G/30 ML SINGLE-USE VIALS     INNOPHARMA INC.ACETADOTE INJECTION11/7/2012 
6PANTOPRAZOLE SODIUM FOR INJECTION, 40 MG (BASE)/SINGLE-DOSE VIAL       AKORN INC.PROTONIX I.V. FOR INJECTION11/8/2012 
7CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS, 18.75 MG/75 MG/200 MG, 25 MG/100 MG/200 MG, 31.25 MG/125 MG/200 MG, 37.5 MG/150 MG/200 MG AND 50 MG/200 MG/200 MG   WOCKHARDT LIMITEDSTALEVO11/20/2012 
8CARBIDOPA, LEVODOPA AND ENTACAPONE TABLETS, 12.5 MG/50 MG/200 MG       WOCKHARDT LIMITEDSTALEVO-50 TABLETS11/20/2012 
9BETAMETHASONE VALERATE FOAM, 0.12%       COBREK PHARMACEUTICALS, INC.LUXIQ FOAM11/26/2012