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

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