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Generic Drug Approvals: September 2005

First Time Generic Approvals

  • Zidovudine Oral Solution USP, 50 mg/5 mL
    Approved: September 19, 2005 Aurobindo Pharma Limited
    Generic for: Retrovir Syrup
  • Zidovudine Tablets USP 300 mg
    Approved: September 19, 2005 Aurobindo Pharma/Roxane/Ranbaxy
    Generic for: Retrovir Tablets
  • Tretinoin Cream USP (Emollient), 0.05%
    Approved: September 15, 2005 Spear Pharmaceuticals
    Generic for: Renova Cream
  • Leflunomide Tablets 10 mg and 20 mg
    Approved: September 13, 2005 Barr Laboratories, Inc.
    Generic for: Arava Tablets

Other Generic Approvals

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