Generic Drug Approvals: December 2005

First Time Generic Approvals

  • Cabergoline Tablets 0.5 mg
    Approved: December 29, 2005 Par Pharmaceutical, Inc.
    Generic for: Dostinex Tablets
  • Zonisamide Capsules 25 mg, 50 mg and 100 mg
    Approved: December 22, 2005 Alphapharm Pty Ltd; Teva Pharmaceuticals USA; Apotex Inc.; Sandoz Inc.; Barr Laboratories, Inc.; Roxane Laboratories, Inc.; Dr. Reddy’s Laboratories Limited (100 mg only); Wockhardt Limited (100 mg only); Mylan Pharmaceuticals, Inc.; Mutual Pharmaceutical Company, Inc.
    Generic for: Zonegran Capsules
  • Azithromycin for Injection 500 mg/vial
    Approved: December 13, 2005 American Pharmaceutical Partners, Inc.
    Generic for: Zithromax For Injection
  • Cefprozil For Oral Suspension USP, 125 mg/5 mL and 250 mg/5 mL
    Approved: December 8, 2005 Teva Pharmaceuticals USA; Sandoz Inc.
    Generic for: Cefzil For Oral Suspension
  • Ribavirin Tablets 200 mg, 400 mg and 600 mg
    Approved: December 5, 2005 Three Rivers Pharmaceuticals, LLC; Zydus Pharmaceuticals USA, Inc. (200 mg only); Teva Pharmaceuticals, Inc. (200 mg only)
    Generic for: Copegus Tablets

Other Generic Approvals

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