Medication Guide App

Generic Drug Approvals: October 2004

First Time Generic Approvals

  • Citalopram Hydrobromide Tablets 10 mg (base), 20 mg (base), and 40 mg (base)
    Generic for: Celexa
    Approved: October 28, 2004
    Aurobindo Pharma Limited, Corepharma LLC, Dr. Reddy’s Laboratories Limited, Eon Labs, Inc., Purepac Pharmaceutical Co.
  • Gabapentin Tablets 600 mg and 800 mg
    Generic for: Neurontin
    Approved: October 21, 2004
    Purepac Pharmaceutical Co.
  • Levofloxacin Tablets 250 mg and 500 mg
    Generic for: Levaquin
    Approved: October 15, 2004
    Mylan Pharmaceuticals, Inc.
  • Metformin Hydrochloride Extended-Release Tablets 750 mg
    Generic for: Glucophage XR
    Approved: October 14, 2004
    Barr Laboratories, Inc.
  • Carboplatin For Injection USP 50 mg, 150 mg, and 450 mg
    Generic for: Paraplatin for Injection
    Approved: October 14, 2004
    American Pharmaceutical Partners, Inc., Bedford Laboratories, Pharmachemie B.V., Mayne Pharma (USA), Inc.
  • Flumazenil Injection 0.1 mg/mL
    Generic for: Romazicon Injection
    Approved: October 12, 2004
    Sicor Pharmaceuticals, Inc., Bedford Laboratories, Baxter Healthcare Corporation, Apotex Corp., American Pharmaceutical Partners, Inc.

All Generic Approvals
  • Citalopram Hydrobromide Tablets 10 mg (base), 20 mg (base), and 40 mg (base)
    Dr. Reddy’s Laboratories Limited Approved: October 28, 2004
    Corepharma LLC Approved: October 28, 2004
    Eon Labs, Inc. Approved: October 28, 2004
    Purepac Pharmaceutical Co. Approved: October 28, 2004
    Aurobindo Pharma Limited Approved: October 28, 2004
  • Lithium Carbonate Extended-Release Tablets USP 300 mg
    Roxane Laboratories, Inc. Approved: October 28, 2004
  • Bethanechol Chloride Tablets USP 5 mg, 10 mg, 25 mg and 50 mg
    Amide Pharmaceutical, Inc. Approved: October 28, 2004
  • Medroxyprogesterone Acetate Injectable Suspension USP 150 mg/mL; in 1 mL prefilled syringes
    Sicor Pharmaceuticals, Inc. Approved: October 27, 2004
  • Enalapril Maleate and Hydrochlorothiazide Tablets USP 5 mg/12.5 mg and 10 mg/25 mg
    Apotex Inc. Approved: October 27, 2004
  • Mirtazapine Tablets 7.5 mg, 15 mg, 30 mg, and 45 mg
    Aurobindo Pharma Limited Approved: October 22, 2004
  • Gabapentin Tablets 600 mg and 800 mg
    Purepac Pharmaceutical Co. Approved: October 21, 2004
  • Cefuroxime Axetil Tablets USP 250 mg (base) and 500 mg (base)
    Teva Pharmaceuticals, USA Approved: October 18, 2004
  • Cefazolin For Injection USP 10 gram/vial; (Pharmacy Bulk Package)
    Hikma Farmaceutica (Portugal), LDA Approved: October 18, 2004
  • Levofloxacin Tablets 250 mg and 500 mg
    Mylan Pharmaceuticals, Inc. Approved: October 15, 2004
  • Metformin Hydrochloride Extended-Release Tablets 750 mg
    Barr Laboratories, Inc. Approved: October 14, 2004
  • Carboplatin For Injection USP 50 mg, 150 mg, and 450 mg
    Mayne Pharma (USA), Inc. Approved: October 14, 2004
    American Pharmaceutical Partners, Inc. Approved: October 14, 2004
    Pharmachemie B.V. Approved: October 14, 2004
    Bedford Laboratories Approved: October 14, 2004
  • Betamethasone Dipropionate Ointment USP (Augmented) 0.05% (base)
    Taro Pharmaceuticals U.S.A., Inc. Approved: October 12, 2004
  • Fenoldopam Mesylate Injection USP 10 mg (base)/mL; packaged in 1 mL and 2 mL single-dose vials
    Bedford Laboratories Approved: October 12, 2004
  • Flumazenil Injection 0.1 mg/mL; packaged in 0.5 mg/5 mL and 1 mg/10 mL multiple dose vials
    Apotex Corp. Approved: October 12, 2004
    Baxter Healthcare Corporation Approved: October 12, 2004
    American Pharmaceutical Partners, Inc. Approved: October 12, 2004
    Sicor Pharmaceuticals, Inc. Approved: October 12, 2004
    Bedford Laboratories Approved: October 12, 2004
  • Fosinopril Sodium Tablets 10 mg, 20 mg, and 40 mg
    Andrx Pharmaceuticals, LLC Approved: October 15, 2004
    Sandoz Inc. Approved: October 8, 2004
  • Gabapentin Capsules 100 mg, 300 mg, and 400 mg
    Teva Pharmaceuticals Usa, Inc. Approved: October 8, 2004
  • Ciprofloxacin Tablets USP 250 mg, 500 mg, and 750 mg
    Taro Pharmaceutical Industries Ltd. Approved: October 6, 2004
  • Ketorolac Tromethamine Injection USP 15 mg/mL; 30 mg/mL, and 60 mg/2 mL single-dose vials
    Sabex 2002 Inc. Approved: October 6, 2004
  • Lisinopril and Hydrochlorothiazide Tablets 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg
    Apotex Inc. Approved: October 5, 2004
  • Loratadine Oral Solution USP (OTC) 5 mg/5 mL
    Apotex Inc. Approved: October 5, 2004
  • Prednisolone Sodium Phosphate Oral Solution 15 mg (base)/5 mL
    Morton Grove Pharmaceuticals, Inc. Approved: October 4, 2004
  • Ribavirin Capsules 200 mg
    Teva Pharmaceuticals USA Approved: October 4, 2004
  • Mefloquine Hydrochloride Tablets 250 mg
    Roxane Laboratories, Inc. Approved: October 1, 2004
  • Metformin Hydrochloride Extended-Release Tablets 500 mg
    Purepac Pharmaceutical Company Approved: October 1, 2004
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