Generic Drug Approvals: January 2005

First Time Generic Approvals

  • Fentanyl Transdermal Systems 25 mcg/hour, 50 mcg/hour, 75 mcg/hour, and 100 mcg/hour
    Approved: January 28, 2005 Company: Mylan Technologies, Inc.
    Generic for: Duragesic Transdermal Systems
    Treatment for: Chronic Pain
  • Desmopressin Acetate Nasal Solution 0.01% (Nasal Spray)
    Approved: January 27, 2005 Company: Apotex Inc.
    Generic for: DDAVP Nasal Spray
    Treatment for: Diabetes Insipidus and Nocturnal Enuresis
  • Levofloxacin Tablets 750 mg
    Approved: January 26, 2005 Company: Teva Pharmaceuticals USA
    Generic for: Levaquin Tablets
    Treatment for: Bacterial Infections
  • Clarithromycin Extended-Release Tablets 1000 mg
    Approved: January 26, 2005 Company: Ranbaxy Laboratories Limited
    Generic for: Biaxin XL Extended-Release Tablets
    Treatment for: Bacterial Infections
  • Estradiol Transdermal System 0.025 mg/day and 0.075 mg/day
    Approved: January 26, 2005 Company: Mylan Technologies, Inc.
    Generic for: Climara
    Treatment for: Menopausal Symptoms
  • Terconazole Vaginal Cream 0.4%
    Approved: January 19, 2005 Company: Taro Pharmaceuticals USA, Inc.
    Generic for: Terazole 7 Vaginal Cream
    Treatment for: Vaginal Candidiasis
  • Potassium Iodide Oral Solution USP 65 mg/mL
    Approved: January 12, 2005 Company: Fleming & Company, Pharmaceuticals
    Generic for: Thyrosafe Tablets
    Treatment for: Thyroid Protection in a Radiation Emergency

Other Generic Approvals

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