First-Time Generic Drug Approvals: September 2009

  • Norethindrone Acetate & Ethinyl Estradiol Tablets USP, & Fe 1 mg/0.02 mg with 75 mg Ferrous Fumarate (24-Day Regimen)
    Approved: September 1, 2009 Watson Laboratotries, Inc.
    Generic for: Loestrin 24 Fe Tablets
  • Temazepam Capsules USP, 7.5 mg
    Approved: September 8, 2009 Mutual Pharmaceutical Company, Inc.
    Generic for: Restoril Capsules 7.5 mg
  • Nateglinide Tablets 60 mg and 120 mg
    Approved: September 9, 2009 Par Pharmaceutical, Inc.; Dr. Reddy's Laboratories; Teva Pharmaceuticals USA
    Generic for: Starlix Tablets
  • Piperacillin and Tazobactam for Injection 36 g (base)/4.5 g (base)/vial, (pharmacy bulk package)
    Approved: September 15, 2009 Orchid Healthcare
    Generic for: Zosyn for Injection (Pharmacy Bulk Package)
  • Piperacillin and Tazobactam for Injection 2 g (base)/250 mg (base)/vial, 3 g (base)/375 mg (base)/vial and 4 g (base)/500 mg (base)/vial
    Approved: September 15, 2009 Orchid Healthcare
    Generic for: Zosyn for Injection
Hide
(web1)