First-Time Generic Drug Approvals: September 2007

• Carvedilol Tablets 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg
  Approved: September 5, 2007 - Dr. Reddy's Laboratories, Inc.; Mylan Pharmaceuticals, Inc.; Zydus Pharmaceuticals USA, Inc.; Lupin Limited; Caraco Pharmaceutical Laboratories Ltd.; Ranbaxy Laboratories Limited; Glenmark Pharmaceuticals Limited; Teva Pharmaceuticals USA
  Generic for: Coreg Tablets
• Ciclopirox Topical Solution (Nail Lacquer) 8%
  Approved: September 18, 2007 - G & W Laboratories, Inc.; Taro Pharmaceutical Industries, Ltd.; Watson Laboratories, Inc.; Actavis Mid Atlantic LLC; Hi-Tech Pharmacal Co., Inc.; Perrigo Company; Apotex Inc.; Tolmar Inc.; Synerx Pharma, LLC; Teva Pharmaceuticals USA
  Generic for: Penlac Nail Lacquer
• Hydrocodone Polistirex and Chlorpheniramine Polistirex 5 mg/4 mg and 10 mg/8 mg
  Approved: September 24, 2007 - Tyco Healthcare Mallinckrodt
  Generic for: Tussinonex Pennkinetic ER Suspension
• Albuterol Sulfate Inhalation Solution 0.021% (base) and 0.042% (base)
  Approved: September 25, 2007 - Watson Laboratories, Inc.
  Generic for: Accuneb Inhalation Solution
• Ofloxacin Otic Solution USP, 0.3%
  Approved: September 28, 2007 - Apotex Inc.
  Generic for: Floxin Otic Solution

Generic Approvals Archive