First-Time Generic Drug Approvals: June 2011

  • Ethinyl Estradiol and Levonorgestrel Tablets USP 0.02 mg/0.09 mg
    Approved: June 6, 2011 - Watson Laboratories, Inc.
    Generic for: Lybrel
  • Clobetasol Propionate Shampoo 0.05%
    Approved: June 7, 2011 - Actavis Mid Atlantic, LLC
    Generic for: Clobex Shampoo
  • Clobetasol Propionate Topical Solution USP, (Spray) 0.05%
    Approved: June 16, 2011 - Paddock Laboratories, Inc.
    Generic for: Clobex Spray
  • Levofloxacin Injection 25 mg/mL; packaged in 500 mg/20 mL and 750 mg/30 mL Single-Use Vials
    Approved: June 20, 2011 - Akorn, Inc.; Sagent Strides, LLC
    Generic for: Levaquin Injection
  • Levofloxacin Tablets 250 mg, 500 mg and 750 mg
    Approved: June 20, 2011 - Aurobindo Pharma Limited; Sandoz, Inc.; Mylan Pharmaceuticals, Inc.; Teva Pharmaceuticals USA; Dr. Reddy's Laboratories Limited; Torrent Pharmaceuticals; Wockhardt Limited; Glenmark Generics Ltd.
    Generic for: Levaquin Tablets
  • Levofloxacin Oral Solution 25 mg/mL
    Approved: June 20, 2011 - Hi-Tech Pharmacal Co., Inc.
    Generic for: Levaquin Oral Solution
  • Sumatriptan Succinate Injection 6 mg (base)/0.5 mL; packaged in a Single-Dose Syringe With Autoinjector
    Approved: June 21, 2011 - Sun Pharma Global FZE
    Generic for: Imitrex Statdose System
  • Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets USP, (OTC) 180 mg/240 mg (24-Hour Formulation)
    Approved: June 22, 2011 - Dr. Reddy's Laboratories Limited
    Generic for: Allegra-D 24 Hour Extended-Release Tablets
  • Flucytosine Capsules USP, 250 mg and 500 mg
    Approved: June 28, 2011 - Sigmapharm Laboratories, LLC
    Generic for: Ancobon
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