Generic Drug Approvals: May 2004

  • Ammonium Lactate Lotion 12% (Base)
    Taro Pharmaceuticals USA, Inc. Approved: May 28, 2004
  • First Time Generic for Sporanox
    Itraconazole Capsules 100 mg
    Eon Labs, Inc. Approved: May 28, 2004
  • Prochlorperazine Edisylate Injection USP 5 mg (base)/mL; packaged in 10 mg (base)/2 mL single-dose vials and 50 mg (base)/10 mL multiple-dose vials
    Bedford Laboratories Approved: May 28, 2004
  • First Time Generic for Metrocream
    Metronidazole Topical Cream 0.75%
    Altana Inc. Approved: May 28, 2004
  • Midodrine Hydrochloride Tablets 2.5 mg and 5 mg
    Impax Laboratories, Inc. Approved: May 27, 2004
  • First Time Generic for Zyban SR
    Bupropion Hydrochloride Extended-Release Tablets 150 mg
    Impax Laboratories, Inc. Approved: May 27, 2004
  • Terbutaline Sulfate Injection USP 1 mg/mL, packaged in 1 mL single-dose vials
    American Pharmaceutical Partners, Inc. Approved: May 26, 2004
  • Amoxicillin & Clavulanate Potassium For Oral Suspension USP 200 mg/28.5 mg (base)/5 mL and 400 mg/57 mg (base)/5 mL
    Teva Pharmaceuticals USA Approved: May 25, 2004
  • Prednisolone Sodium Phosphate Oral Solution 5 mg (Base)/ 5 mL
    Paddock Laboratories, Inc. Approved: May 25, 2004
  • First Time Generic for Biaxin
    Clarithromycin Tablets USP 250 mg and 500 mg
    Roxane Laboratories, Inc. Approved: May 25, 2004
  • Diltiazem Hydrochloride Extended-Release Capsules USP 120 mg, 180 mg, 240 mg, 300 mg (Once-A-Day Dosage)
    Torpharm Inc. Approved: May 20, 2004
  • Morphine Sulfate Extended-Release Tablets 15 mg
    KV Pharmaceutical Company approved: May 19, 2004
  • Morphine Sulfate Extended-Release Tablets 60 mg
    KV Pharmaceutical Company Approved: May 19, 2004
  • First Time Generic for Ocuflox
    Ofloxacin Ophthalmic Solution USP 0.3%
    Novex Pharma Approved: May 14, 2004
  • Ofloxacin Ophthalmic Solution USP 0.3%
    Alcon Inc. Approved: May 14, 2004
  • Ofloxacin Ophthalmic Solution USP 0.3%
    Bausch & Lomb, Inc. Approved: May 14, 2004
  • Ofloxacin Ophthalmic Solution USP 0.3%
    Hi-Tech Pharmacal Co., Inc. Approved: May 14, 2004
  • First Time Generic for Cutivate
    Fluticasone Propionate Cream 0.05%
    Atrix Laboratories, Inc. Approved: May 14, 2004
  • Fluticasone Propionate Cream 0.05%
    Clay-Park Labs, Inc. Approved: May 14, 2004
  • Fluticasone Propionate Ointment 0.005%
    Clay-Park Labs, Inc. May 14, 2004
  • Fluticasone Propionate Cream 0.05%
    Altana Inc. Approved: May 14, 2004
  • Fluticasone Propionate Ointment 0.005%
    Altana Inc. Approved: May 14, 2004
  • Fluoxetine Oral Solution USP 20 mg (base)/5 mL
    Par Pharmaceutical, Inc. Approved: May 14, 2004
  • Carbidopa-Levodopa Extended-Release Tablets 25 mg/100 mg & 50 mg/200 mg
    Impax Laboratories, Inc. Approved: May 14, 2004
  • First Time Generic for Darvocet N 100
    Propoxyphene Napsylate and Acetaminophen Tablets USP 100 mg/325 mg
    Vintage Pharmaceuticals, Inc. Approved: May 7, 2004
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