First-Time Generic Drug Approvals: December 2007

  • Fomepizole Injection 1 g/mL
    Approved: December 14, 2007 Pharmaforce, Inc.
    Generic for: Antizol Injection
  • Extended Phenytoin Sodium Capsules USP 30 mg
    Approved: December 18, 2007 Wockhardt Limited
    Generic for: Dilantin (Extended Phenytoin Sodium Capsules)
  • Cetirizine Hydrochloride Tablets (OTC) 5 mg and 10 mg
    Approved: December 27, 2007 Mylan Pharmaceuticals, Inc.; Caraco Pharmaceutical Laboratories, Ltd.; Par Pharmaceutical, Inc.; Ranbaxy Laboratories Limited; Sandoz Inc.
    Generic for: Zyrtec Allergy Tablets/Zyrtec Hives Relief Tablets
  • Diclofenac Sodium Ophthalmic Solution 0.1%
    Approved: December 28, 2007 Bausch & Lomb Inc.; Nexus Pharmaceuticals, Inc.
    Generic for: Voltaren Ophthalmic Solution
  • Balsalazide Disodium Capsules 750 mg
    Approved: December 28, 2007 Roxane Laboratories, Inc.
    Generic for: Colazal Capsules
  • Granisetron Hydrochloride Injection 0.1 mg (base)/1 mL; packaged in 0.1 mg (base)/ 1 mL Single-Use Vials
    Approved: December 31, 2007 App Pharmaceuticals, LLC; Watson Laboratories, Inc.
    Generic for: Kytril Injection
  • Granisetron Hydrochloride Injection (Preservative-Free) 1 mg (base)/mL; packaged in 1 mg (base)/1 mL Single-Dose Vials
    Approved: December 31, 2007 Teva Parenteral Medicines, Inc.
    Generic for: Kytril Injection
  • Granisetron Hydrochloride Injection 1 mg (base)/mL; packaged in 4 mg (base)/4 mL Multiple-Dose Vials
    Approved: December 31, 2007 Baxter Healthcare Corporation
    Generic for: Kytril Injection
  • Granisetron Hydrochloride Tablets 1 mg (base)
    Approved: December 31, 2007 Barr Laboratories, Inc.; Teva Pharmaceuticals USA; Corepharma LLC; Roxane Laboratories, Inc.
    Generic for: Kytril Tablets
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