First-Time Generic Drug Approvals: February 2009

• Risperidone Orally Disintegrating Tablets 0.5 mg and 2 mg
  Approved: February 24, 2009 Dr. Reddy's Laboratories Limited
  Generic for: Risperdal M-Tab (Orally Disintegrating Tablet)
• Sumatriptan Succinate Tablets 25 mg (base), 50 mg (base) and 100 mg (base)
  Approved: February 9, 2009 Teva Pharmaceuticals USA; Ranbaxy Laboratories Limited (100 mg (base) only)
  Generic for: Imitrex Tablets
• Sumatriptan Succinate Injection (Syringe) 4 mg (base)/0.5 mL and 6 mg (base)/0.5 mL; Pre-Filled Syringes
  Approved: February 6, 2009 Teva Parenteral Medicines
  Generic for: Imitrex Injection, Pre-Filled Syringes
• Sumatriptan Succinate Injection 4 mg (base)/0.5 mL and 6 mg (base)/0.5 mL; Single-Dose Vials
  Approved: February 6, 2009 Sandoz Canada, Inc.; Teva Parenteral Medicines (6 mg (base)/0.5 mL only); Bedford Laboratories (6 mg (base)/0.5 mL only)
  Generic for: Imitrex Injection, Single Dose Vials
• Minocycline Hydrochloride Extended-Release Tablets 45 mg (base), 90 mg (base) and 135 mg (base)
  Approved: February 3, 2009 Impax Laboratories, Inc.
  Generic for: Solodyn Tablets

Generic Approvals Archive