First-Time Generic Drug Approvals: November 2009

• Ketorolac Tromethamine Ophthalmic Solution 0.5%
  Approved: November 5, 2009 Alcon Inc.; Akorn Inc.; Sun Pharma Global, Inc.
  Generic for: Acular Ophthalmic Solution
• Ketorolac Tromethamine Ophthalmic Solution 0.4%
  Approved: November 5, 2009 Apotex Inc.; Alcon Inc.; Akorn Inc.
  Generic for: Acular LS Ophthalmic Solution
• Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.005 mg
  Approved: November 6, 2009 Barr Laboratories, Inc.
  Generic for: Femhrt Tablets 1 mg/0.005 mg
• Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg
  Approved: November 10, 2009 Teva Pharmaceuticals USA; Matrix Laboratories Limited
  Generic for: Prevacid Delayed-Release Capsules
• Perindopril Erbumine Tablets 2 mg, 4 mg and 8 mg
  Approved: November 10, 2009 Aurobindo Pharma Limited; Roxane Laboratories, Inc.; IVAX Pharmaceuticals, Inc.
  Generic for: Aceon Tablets
• Tramadol Hydrochloride Extended-Release Tablets 100 mg and 200 mg
  Approved: November 13, 2009 Par Pharmaceutical, Inc.
  Generic for: Ultram ER Tablets, 100 mg and 200 mg
• Nicardipine Hydrochloride Injection 2.5 mg/mL; packaged in 25 mg/10 mL Single-Dise Vials
  Approved: November 17, 2009 Generamedix, Inc.; Pharmaforce, Inc.; Navinta, LLC; Sun Pharma Global, Inc.; Wockhardt Limited
  Generic for: Cardene I.V. Injection
• Nizatidine Oral Solution 15 mg/mL
  Approved: November 18, 2009 Amneal Pharmaceuticals
  Generic for: Axid Oral Solution

Generic Approvals Archive