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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - June 2014

 Generic Drug NameGeneric ManufacturerBrand NameTentative Approval DateApproval Date
1LISDEXAMFETAMINE DIMESYLATE CAPSULES, 20 MG, 30 MG, 40 MG, 50 MG AND 70 MG   ROXANE LABORATORIES, INC.VYVANSE CAPSULES6/23/2014  
2DAPTOMYCIN FOR INJECTION USP, 500 MG/SINGLE-USE VIAL       HOSPIRA INC.CUBICIN FOR INJECTION6/16/2014  
3METHOXALEN CAPSULES USP, (SOFT GELATIN CAPSULES) 10 MG      STRIDES ARCOLAB LIMITEDOXSORALEN-ULTRA CAPSULES 6/5/2014 
4RISEDRONATE SODIUM TABLETS USP, 75 MG AND 150 MG      APOTEX INC.ACTONEL TABLETS 6/10/2014 
5ERLOTINIB TABLETS, 25 MG, 100 MG AND 150 MG     MYLAN PHARMACEUTICALS, INC.TARCEVA TABLETS 6/11/2014 
6CODEINE SULFATE TABLETS USP, 15 MG, 30 MG AND 60 MG     LANNETT HOLDINGS, INC.CODEINE SULFATE TABLETS, USP 6/13/2014 
7VALSARTAN TABLETS USP, 40 MG, 80 MG, 160 MG AND 320 MG    OHM LABORATORIES, INC.DIOVAN TABLETS 6/26/2014 
8ARGATOBAN INJECTION, 100 MG/ML; PACKAGED IN 250 MG/2.5 ML SINGLE-DOSE VIALS     PAR STERILE PRODUCTS, LLCACOVA INJECTION 6/30/2014 
9ARGATROBAN INJECTION, 100 MG/ML; PACKAGED IN 250 MG/2.5 ML SINGLE-DOSE VIALS     MYLAN INSTITUTIONAL LLCACOVA INJECTION 6/30/2014