Generic Drug Approvals: April 2004

  • Theophylline Extended-Release Tablets 300mg and 450 mg
    Able Laboratories, Inc. Approved: April 30, 2004
  • Metolazone Tablets, USP 10 mg
    Roxane Laboratories, Inc. Approved: April 29, 2004
  • Ketoconazole Cream 2%
    Altana Inc. Approved: April 28, 2004
  • First Time Generic for Fludara for Injection
    Fludarabine Phosphate Injection 25 mg/mL; packaged in 50 mg/2 mL Single-Dose Vials
    Sicor Pharmaceuticals, Inc. Approved: April 28, 2004
  • First Time Generic for Neurontin 100 mg
    Gabapentin Tablets 100 mg, 300 mg, and 400 mg
    Ivax Pharmaceuticals, Inc. Approved: April 28, 2004
  • First Time Generic for Uniphyl
    Theophylline Extended-Release Tablets 400 mg and 600 mg
    Able Laboratories, Inc. Approved: April 27, 2004
  • Methadone Hydrochloride Tablets, USP 5 mg and 10 mg
    Mallinckrodt Inc. Approved: April 27, 2004
  • First Time Generic for Brethine Injection
    Terbutaline Sulfate Injection, UAP 1 mg/mL
    Bedford Laboratories Approved: April 23, 2004
  • Fosinopril Sodium Tablets 10 mg, 20 mg, and 40 mg
    Eon Labs, Inc. Approved: April 23, 2004
  • Fosinopril Sodium Tablets 10 mg, 20 mg, and 40 mg
    Ranbaxy Laboratories Limited Approved: April 23, 2004
  • Propafenone Hydrochloride Tablets 150 mg, 225 mg, and 300 mg
    Pliva, Inc. Approved: April 23, 2004
  • First Time Generic for Remeron
    Mirtazapine Tablets 7.5 mg, 15 mg, 30 mg, and 45 mg
    Caraco Pharmaceutical Laboratories, Ltd. Approved: April 22, 2004
  • First Time Generic for Ovcon-35
    Norethindrone and Ethinyl Estradiol Tablets, USP 0.4 mg/0.035 mg; 21-Day Cycle (Balziva-21 Tablets)
    Barr Laboratories, Inc. Approved: April 22, 2004
  • First Time Generic for Ovcon-35
    Norethindrone and Ethinyl Estradiol Tablets, USP 0.4 mg/0.035 mg; 28-Day Cycle (Balziva-28 Tablets)
    Barr Laboratories, Inc. Approved: April 22, 2004
  • Cladribine Injection 1 mg/mL; packaged in 10 mL Single-Dose Vials
    American Pharmaceutical Partners, Inc. Approved: April 22, 2004
  • Diazepam Injection, USP 5 mg/mL packaged in 5 mg/1 mL and 10 mg/2 mL Single-Dose Vials & 50 mg/mL Multiple-Dose Vials
    Parenta Pharmaceuticals, Inc. Approved: April 15, 2004
  • Sotalol Hydrochloride Tablets 80 mg, 120 mg, and 160 mg
    Mutual Pharmaceutical Company, Inc. Approved: April 8, 2004
  • First Time Generic for Rebetol
    Ribavirin Capsules 200 mg
    Sandoz, Inc. Approved: April 6, 2004
  • First Time Generic for Rebetol
    Ribavirin Capsules 200 mg
    Three Rivers Pharmaceuticals, LLC Approved: April 6, 2004
  • First Time Generic for Terazol 3
    Terconazole Vaginal Cream 0.8%
    Taro Pharmaceuticals U.S.A., Inc. Approved: April 6, 2004
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