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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