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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - September 2012

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS, 80 MG/12.5 MG, 160 MG/12.5 MG, 160 MG/25 MG, 320 MG/12.5 MG AND 320 MG/25 MG   MYLAN PHARMACEUTICALS, INC.DIOVAN HCT TABLETS9/21/2012 
2APREPITANT CAPSULES, 40 MG, 80 MG AND 125 MG     SANDOZ INC.EMEND CAPSULES9/24/2012 
3AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS, 5 MG/160 MG/12.5 MG, 10 MG/160 MG/12.5 MG, 5 MG/160 MG/25 MG, 10 MG/160 MG/25 MG AND 10 MG/320 MG/25 MG   TEVA PHARMACEUTICALS, USAEXFORGE HCT TABLETS9/25/2012 
4QUININE SULFATE CAPSULES USP, 324 MG       TEVA PHARMACEUTICALS, USAQUALAQUIN CAPSULES9/28/2012 
5PROGESTERONE CAPSULES, 100 MG AND 200 MG      SOFGEN PHARMACEUTICALS, LLCPROMETRIUM CAPSULES9/28/2012