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First-Time Generic Drug Approvals: March 2009

  • Carbamazepine Extended-Release Tablets USP 100 mg, 200 mg and 400 mg
    Approved: March 31, 2009 Taro Pharmaceuticals USA, Inc.
    Generic for: Tegretol-XR Tablets
  • Drospirenone and Ethinyl Estradiol Tablets 3 mg/0.02 mg (28-Day Regimen)
    Approved: March 30, 2009 Barr Laboratories, Inc.
    Generic for: Yaz Tablets
  • Topiramate Tablets 25 mg, 50 mg, 100 mg and 200 mg
    Approved: March 27, 2009 Torrent Pharmaceuticals Limited; Ranbaxy Laboratories Limited (not 50 mg); Par Pharmaceutical, Inc.; Cipla Limited; Mylan Pharmaceuticals Inc.; Apotex Inc.; Cobalt Laboratories; Glenmark Generics Limited; Roxane Laboratories, Inc.; Barr Laboratories, Inc. (not 50 mg); Sun Pharmaceutical Industries, Ltd.; Invagen Pharmaceuticals, Inc.; Aurobindo Pharma Limited; Unichem Laboratories Limited (not 200 mg); Zydus Pharmaceuticals USA, Inc.; Teva Pharmaceuticals USA
    Generic for: Topamax Tablets
  • Ibuprofen Capsules, 200 mg (Liquid Filled Capsule) (OTC)
    Approved: March 24, 2009 Banner Pharmacaps, Inc.
    Generic for: Advil Liqui-Gels Capsules
  • Levalbuterol Inhalation Solution USP, (Concentrate) 0.25% (1.25 mg/0.5mL)
    Approved: March 20, 2009 Dey LP
    Generic for: Xopenex Inhalation Solution (Concentrate)
  • Liothyronine Sodium Tablets USP 5 mcg, 25 mcg, and 50 mcg
    Approved: March 20, 2009 Coastal Pharmaceuticals
    Generic for: Cytomel Tablets
  • Apraclonidine Ophthalmic Solution USP 0.5% (base)
    Approved: March 12, 2009 Akorn, Inc.
    Generic for: Iopidine Ophthalmic Solution, 0.5%
  • Malathion Lotion USP 0.5%
    Approved: March 6, 2009 Synerx Pharma, LLC
    Generic for: Ovide Lotion, 0.5%

Generic Approvals Archive