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
