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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - January 2011

  Generic Drug Name   Generic Manufacturer Brand Name  Approval Date 
 1  FENTANYL BUCCAL TABLETS, 100 MCG, 200 MCG, 400 MCG, 600 MCG AND 800 MCG     WATSON LABORATORIES, INC.  CEPHALON, INC.  1/7/2011
 2  ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS, 250 MG/100 MG         GLENMARK GENERICS LIMITED  MALARONE TABLETS  1/12/2011
 3  GEMCITABINE FOR INJECTION USP, 200 MG/VIAL AND 1 GRAM/VIAL        TEVA PARENTERAL MEDICINES, INC.  GEMZAR FOR INJECTION  1/25/2011
 4  NISOLDIPINE EXTENDED-RELEASE TABLETS, 8.5 MG, 17 MG, 25.5 MG AND 34 MG      MYLAN PHARMACEUTICALS, INC.  SULAR EXTENDED-RELEASE TABLETS  1/26/2011