Generic Drug Approvals: July 2004

  • First Time Generic for Diflucan Tablets
    Fluconazole Tablets 50 mg, 100 mg, 150 mg and 200 mg
    Sandoz Inc. Approved: July 29, 2004
    Mylan Pharmaceuticals, Inc. Approved: July 29, 2004
    Novopharm Limited Approved: July 29, 2004
    Apotex Inc. Approved: July 29, 2004
  • First Time Generic for Diflucan For Oral Suspension
    Fluconazole For Oral Suspension 10 mg/mL (50 mg/5 mL) and 40 mg/mL (200 mg/5 mL)
    Ranbaxy Laboratories Limited Approved: July 29, 2004
    Roxane Laboratories, Inc. Approved: July 29, 2004
  • First Time Generic for Diflucan (in 0.9% Sodium Chloride) Injection
    Fluconazole (in 0.9% Sodium Chloride) Injection 2 mg/mL; packaged in 200 mg/100 mL, and 400 mg/200 mL single-dose vials
    Sicor Pharmaceuticals, Inc. Approved: July 29, 2004
    Bedford Laboratories Approved: July 29, 2004
  • First Time Generic for Depo-Provera Injectable Suspension
    Medroxyprogesterone Acetate Injectable Suspension, USP 150 mg/1 mL single-dose vials
    Sicor Pharmaceuticals, Inc. Approved: July 28, 2004
  • First Time Generic for Lotrisone Lotion
    Clotrimazole and Betamethasone Dipropionate Lotion 1%/0.05% (Base)
    Taro Pharmaceuticals U.S.A., Inc. Approved: July 28, 2004
  • Bethanechol Chloride Tablets, USP 5 mg, 10 mg, 25 mg, and 50 mg
    Able Laboratories, Inc. Approved: July 27, 2004
  • Sotalol Hydrochloride Tablets, USP (AF) 80 mg, 120 mg, and 160 mg
    Teva Pharmaceuticals USA Approved: July 26, 2004
  • Nystatin Topical Powder, USP 100,000 units/gram
    Kali Laboratories, Inc. Approved: July 23, 2004
  • Hydroxyzine Hydrochloride Tablets, USP 10 mg, 25 mg and 50 mg
    Able Laboratories, Inc. Approved: July 22, 2004
  • Metolazone Tablets, USP 10 mg
    Watson Laboratories, Inc. Approved: July 21, 2004
  • Ketorolac Tromethamine Injection, USP 15 mg/mL, 30 mg/mL, and 60 mg/2 mL, packaged in single-dose vials
    Amphastar Pharmaceuticals, Inc. Approved: July 21, 2004
  • Ketorolac Tromethamine Injection, USP 15 mg/mL, 30 mg/mL, and 60 mg/2 mL; single-dose vials
    Baxter Healthcare Corporation Approved: July 21, 2004
  • Terbutaline Sulfate Injection, USP 1 mg/mL; packaged in 1 mL single-dose vials
    Sicor Pharmaceuticals, Inc. Approved: July 20, 2004
  • Midazolam Hydrochloride Injection 1 mg (Base)/mL and 5 mg (Base)/mL
    International Medication Systems, Limited Approved: July 16, 2004
  • Nystatin Topical Powder, USP 100,000 units/gram
    Tanon Pharmaceuticals LLC Approved: July 15, 2004
  • First Time Generic for Levoxyl Tablets
    Levothyroxine Sodium Tablets, USP 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg 0.125 mg, 0.15 mg, 0.175 mg, 0.2 mg, and 0.3 mg Are "AB"-Rated To Levoxyl Tablets Of Jones Pharma Inc.
    Mylan Pharmaceuticals, Inc. Approved: July 13, 2004
  • First Time Generic for Pipracil For Injection
    Piperacillin For Injection, USP 40 g/vial (Pharmacy Bulk Package)
    Istituto Biochimico Italiano, S.P.A. Approved: July 12, 2004
  • First Time Generic for MiraLax Powder For Oral Solution
    Glycolax (Polyethylene Glycol 3350 Powder For Oral Solution)
    Schwarz Pharma, Inc. Approved: July 2, 2004
  • First Time Generic for Phenergan Tablets
    Promethazine Hydrochloride Tablets, USP 12.5 mg, 25 mg, and 50 mg
    Able Laboratories, Inc. Approved: July 1, 2004
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