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