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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - June 2011

  Generic Drug Name  Generic Manufacturer Brand Name Approval Date
 1  LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP, 0.09 MG/0.02 MG  WATSON LABORATORIES, INC. LYBREL TABLETS 6/6/2011
 2 CLOBETASOL PROPIONATE SHAMPOO, 0.05% ACTAVIS MID ATLANTIC, LLC CLOBEX SHAMPOO 6/7/2011
 3 CLOBETASOL PROPIONATE TOPICAL SOLUTION USP, (SPRAY) 0.05% PADDOCK LABORATORIES, INC. CLOBEX SPRAY 6/16/2011
 4 LEVOFLOXACIN INJECTION, 25 MG/ML; PACKAGED IN 500 MG/20 ML AND 750 MG/30 ML SINGLE-USE VIALS AKORN, INC. LEVAQUIN INJECTION 6/20/2011
 5 LEVOFLOXACIN TABLETS, 250 MG, 500 MG AND 750 MG AUROBINDO PHARMA LIMITED LEVAQUIN TABLETS 6/20/2011
 6 LEVOFLOXACIN TABLETS, 250 MG, 500 MG AND 750 MG SANDOZ, INC. LEVAQUIN TABLETS 6/20/2011
 7 LEVOFLOXACIN TABLETS, 250 MG, 500 MG MYLAN PHARMACEUTICALS, INC. LEVAQUIN TABLETS 6/20/2011
 8 LEVOFLOXACIN ORAL SOLUTION, 25 MG/ML HI-TECH PHARMACAL CO., INC. LEVAQUIN ORAL SOLUTION 6/20/2011
 9 LEVOFLOXACIN INJECTION, 25 MG/ML; PACKAGED IN 500 MG/20 ML AND 750 MG/30 ML SINGLE-USE VIALS SAGENT STRIDES, LLC LEVAQUIN INJECTION 6/20/2011
 10 LEVOFLOXACIN TABLETS, 250 MG, 500 MG, AND 750 MG TEVA PHARMACEUTICALS USA LEVAQUIN TABLETS 6/20/2011
 11 LEVOFLOXACIN TABLETS, 250 MG, 500 MG, AND 750 MG DR. REDDY'S LABORATORIES LIMITED LEVAQUIN TABLETS 6/20/2011
 12 LEVOFLOXACIN TABLETS, 250 MG, 500 MG, AND 750 MG TORRENT PHARMACEUTICALS LEVAQUIN TABLETS 6/20/2011
 13 LEVOFLOXACIN TABLETS, 250 MG, 500 MG, AND 750 MG WOCKHARDT LIMITED LEVAQUIN TABLETS 6/20/2011
 14 LEVOFLOXACIN TABLETS, 250 MG, 500 MG, AND 750 MG GLENMARK GENERICS LTD. LEVAQUIN TABLETS 6/20/2011
 15 SUMATRIPTAN SUCCINATE INJECTION, 6 MG (BASE)/0.5 ML; PACKAGED IN A SINGLE-DOSE SYRINGE WITH AUTOINJECTOR SUN PHARMA GLOBAL FZE IMITREX STATDOSE SYSTEM 6/21/2011
 16 FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL EXTENDED-RELEASE TABLETS USP, (OTC) 180 MG/240 MG (24-HOUR FORMULATION) DR. REDDY'S LABORATORIES LIMITED ALLEGRA-D 24 HOUR EXTENDED-RELEASE TABLETS 6/22/2011
 17 FLUCYTOSINE CAPSULES USP, 250 MG AND 500 MG SIGMAPHARM LABORATORIES, LLC ANCOBON CAPSULES, 250 MG AND 500 MG 6/28/2011