Generic Drug Approvals: December 2004

First Time Generic Approvals

  • Ciclopirox Olamine Cream USP 0.77%
    Approved: December 29, 2004 Company: Altana Inc.
    Generic for: Loprox Cream
    Treatment for: Topical Fungal Infections
  • Hydrocortisone Butyrate Ointment USP 0.1%
    Approved: December 27, 2004
    Company: Taro Pharmaceutical Industries Ltd.
    Generic for: Locoid Ointment
    Treatment for: Inflammatory Skin Conditions
  • Clindamycin Phosphate Vaginal Cream USP 2% (Base)
    Approved: December 27, 2004 Company: Altana Inc.
    Generic for: Cleocin Vaginal Cream
    Treatment for: Vaginal Bacterial Infections
  • Glycopyrrolate Tablets USP 1 mg and 2 mg
    Approved: December 22, 2004 Company: Corepharma LLC
    Generic for: Robinul & Robinul Forte
    Treatment for: Peptic Ulcers
  • Mometasone Furoate Cream USP 0.1%
    Approved: December 21, 2004
    Company: Taro Pharmaceuticals U.S.A., Inc.
    Generic for: Elocon Cream
    Treatment for: Inflammatory Skin Conditions
  • Halobetasol Propionate Cream 0.05%
    Approved: December 16, 2004
    Company: Agis Industries (1983) Ltd., Altana Inc.
    Generic for: Ultravate Cream
    Treatment for: Inflammatory Skin Conditions
  • Halobetasol Propionate Ointment 0.05%
    Approved: December 16, 2004
    Company: Agis Industries (1983) Ltd., Altana Inc., Taro Pharmaceuticals USA, Inc.
    Generic for: Ultravate Ointment
    Treatment for: Inflammatory Skin Conditions
  • Quinapril Tablets USP 5 mg, 10 mg, 20 mg, and 40 mg
    Approved: December 15, 2004
    Company: Ranbaxy Laboratories Limited
    Generic for: Accupril Tablets
    Treatment for: Hypertension
  • Citalopram Hydrobromide Oral Solution 10 mg (Base)/ 5 mL
    Approved: December 13, 2004 Company: Roxane Laboratories, Inc.
    Treatment for: Celexa Oral Solution
    Treatment for: Depression
  • Didanosine Delayed-Release Capsules 200 mg, 250 mg, and 400 mg
    Approved: December 3, 2004 Company: Barr Laboratories, Inc.
    Generic for: Videx EC Delayed-Release Capsules
    Treatment for: HIV Infection
  • Bupropion Hydrochloride Extended-Release Tablets USP 200 mg
    Approved: December 3, 2004 Company: Impax Laboratories, Inc.
    Generic for: Wellbutrin SR Sustained-Release Tablets
    Treatment for: Depression
  • Fosinopril Sodium And Hydrochlorothiazide Tablets 10 mg/12.5 mg and 20 mg/12.5 mg
    Approved: December 3, 2004 Company: Andrx Pharmaceuticals,LLC
    Generic for: Monopril HCT Tablets
    Treatment for: Hypertension
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