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

Generic Approvals Archive