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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