First-Time Generic Drug Approvals: December 2008

  • Stavudine Capsules USP, 15 mg, 20 mg, 30 mg and 40 mg
    Approved: December 29, 2008 Hetero Drugs Limited; Aurobindo Pharma Limited; Matrix Laboratories Limited
    Generic for: Zerit Capsules
  • Stavudine for Oral Solution USP, 1 mg/mL; (200 mL upon reconstitution)
    Approved: December 29, 2008 Aurobindo Pharma USA, Inc.
    Generic for: Zerit for Oral Solution
  • Letrozole Tablets USP, 2.5 mg
    Approved: December 24, 2008 Mylan Pharmaceuticals, Inc.
    Generic for: Femara Tablets
  • Ibuprofen and Diphenhydramine Citrate Tablets (OTC), 200 mg/38 mg
    Approved: December 22, 2008 Perrigo R&D Company
    Generic for: Advil PM Tablets
  • Gemcitabine for Injection USP, 200 mg/single-use vial and 1 gram/single-use vial
    Approved: December 18, 2008 Teva Parenteral Medicines, Inc.
    Generic for: Gemzar for Injection
  • Acetazolamide Extended Release Capsules 500 mg
    Approved: December 10, 2008 Zydus Pharmaceuticals USA Inc.
    Generic for: Diamox Capsules
  • Clobetasol Propionate Lotion 0.05%
    Approved: December 4, 2008 Actavis Mid Atlantic LLC
    Generic for: Clobex Topical Lotion
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