Generic Drug Approvals: July 2006
First Time Generic Approvals
- Metoprolol Succinate
Extended-Release Tablets USP 25 mg
Approved: July 31, 2006 Sandoz Inc.
Generic for: Toprol-XL Extended Release Tablets - Finasteride Tablets
USP 1 mg
Approved: July 28, 2006 Dr. Reddy’s Laboratories Limited
Generic for: Propecia Tablets - Estradiol
Transdermal System 0.0375 mg/24 hours and 0.06 mg/24 hours
(Additional Strengths)
Approved: July 20, 2006 Mylan Technologies, Inc.
Generic for: Climara Transdermal System - Meloxicam Tablets 7.5
mg and 15 mg
Approved: July 19, 2006 Breckenridge Pharmaceutical, Inc., Corepharma LLC, Caraco Pharmaceutical Laboratories, Ltd., Lupin Limited, Mylan Pharmaceuticals, Inc., Watson Laboratories, Inc., Zydus Pharmaceuticals USA, Inc., Roxane Laboratories, Inc., Teva Pharmaceuticals, USA, Glenmark Pharmaceuticals Ltd., Par Pharmaceutical, Mutual Pharmaceutical Company, Inc., Actavis Totowa LLC, Lupin Limited
Generic for: Mobic Tablets - Azithromycin for Oral
Suspension USP, 100 mg/5 mL and 200 mg/5 mL
Approved: July 5, 2006 Pliva, Inc.
Generic for: Zithromax for Oral Suspension
Other Generic Approvals
- Alprazolam
Extended-Release Tablets 0.5 mg, 1 mg, 2 mg, and 3 mg
Approved: July 31, 2006 Barr Laboratories, Inc. - Promethazine
Hydrochloride Tablets USP, 25 mg and 50 mg
Approved: July 31, 2006 KVK-Tech, Inc. - Metformin Hydrochloride
Tablets USP, 500 mg, 850 mg, and 1000 mg
Approved: July 28, 2006 Amneal Pharmaceuticals LLC - Neomycin Sulfate
Tablets USP, 500 mg [350 mg (Base)]
Approved: July 28, 2006 X-Gen Pharmaceuticals, Inc. - Ursodiol Capsules USP
300 mg
Approved: July 27, 2006 Corepharma LLC - Gemfibrozil Tablets
USP 600 mg
Approved: July 27, 2006 Invagen Pharmaceuticals, Inc. - Primidone Tablets USP
50 mg and 250 mg
Approved: July 27, 2006 West-Ward Pharmaceutical Corp. - Tramadol
Hydrochloride and Acetaminophen Tablets 37.5 mg/325 mg
Approved: July 26, 2006 Barr Laboratories, Inc. - Metformin Hydrochloride
Extended-Release Tablets 500 mg
Approved: July 26, 2006 Synovics Laboratories, Inc. - Meloxicam Tablets 7.5
mg and 15 mg
Approved: July 25, 2006 Dr. Reddy’s Laboratories Limited - Erythromycin
Pledgets USP, 2%
Approved: July 25, 2006 Altana Inc. - Ampicillin
and Sulbactam for Injection USP 1.5 g, 3 g (and 5 g, 10 g
Pharmacy Bulk Package)
Approved: July 25, 2006 Sandoz Inc. - Meloxicam Tablets 7.5
mg and 15 mg
Approved: July 20, 2006 Apotex Inc., Genpharm Inc. - Metronidazole
Topical Gel USP, 0.75%
Approved: July 18, 2006 Taro Pharmaceutical Industries Ltd. - Promethazine
Hydrochloride Tablets USP, 12.5 mg, 25 mg, and 50 mg
Approved: July 18, 2006 Vintage Pharmaceuticals, LLC - Metronidazole
Topical Gel USP, 0.75%
Approved: July 13, 2006 QLT USA, Inc. - Terconazole
Vaginal Suppositories 80 mg
Approved: July 12, 2006 Altana Inc. - Glipizide Tablets USP
5 mg and 10 mg
Approved: July 11, 2006 Caraco Pharmaceutical Laboratories, Ltd. - Cephalexin for Oral
Suspension USP 125 mg/5 mL and 250 mg/5 mL
Approved: July 10, 2006 Orchid Healthcare - Gabapentin Tablets
600 mg and 800 mg
Approved: July 6, 2006 Sandoz Inc. - Fosinopril Sodium and
Hydrochlorothiazide 10 mg/12.5 mg and 20 mg/12.5 mg
Approved: July 5, 2006 Teva Pharmaceuticals USA - Amiodarone Hydrochloride
Injection 50 mg/mL; 3 mL Ampules
Approved: July 5, 2006 Akorn Inc. - Warfarin Sodium
Tablets USP 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg,
and 10 mg
Approved: July 5, 2006 Pliva Inc. - Citalopram Hydrobromide
Tablets 10 mg (base), 20 mg (base), and 40 mg (base)
Approved: July 3, 2006 Mutual Pharmaceutical Company, Inc.
