Generic Drug Approvals: December 2006
First Time Generic Approvals
- Methscopolamine
Bromide Tablets USP, 2.5 mg and 5 mg
Approved: December 28, 2006 Boca Pharmacal, Inc.
Generic for: Pamine Tablets & Pamine Forte Tablets - Ondansetron Orally
Disintegrating Tablets USP, 4 mg, 8 mg, 16 mg and 24 mg
Approved: December 26, 2006 Kali Laboratories, Inc.
Generic for: Zofran ODT - Ondansetron
Hydrochloride Tablets 4 mg (base), 8 mg (base), 16 mg (base)
and 24 mg (base)
Approved: December 26, 2006 Dr. Reddy’s Laboratories Limited
Generic for: Zofran Tablets - Ondansetron Oral
Solution USP, 4 mg/5 mL
Approved: December 26, 2006 Roxane Laboratories, Inc.
Generic for: Zofran Oral Solution -
Albuterol Sulfate & Ipratropium Bromide Inhalation Solution
3 mg (0.083%) and 0.5 mg (0.017%); 3 mL vials
Approved: December 21, 2006 Sandoz Inc.
Generic for: Duoneb Inhalation Solution - Bupropion Hydrochloride
Extended-Release Tablets USP, 150 mg and 300 mg
(once-a-day)
Approved: December 14, 2006 Anchen Pharmaceuticals, Inc.
Generic for: Wellbutrin XL Extended Release Tablets - Trandolapril
Tablets 1 mg, 2 mg, and 4 mg
Approved: December 12, 2006 Teva Pharmaceuticals USA
Generic for: Mavik Tablets - Paroxetine Hydrochloride
Oral Suspension, 10 mg/5 mL
Approved: December 4, 2006 Apotex Inc.
Generic for: Paxil Oral Suspension - Oxandrolone Tablets
USP, 2.5 mg and 10 mg
Approved: December 1, 2006 Upsher-Smith Laboratories, Inc. (2.5 mg); Sandoz Inc. (2.5 mg and 10 mg)
Generic for: Oxandrin Tablets
Other Generic Approvals
- Amoxicillin for Oral
Suspension USP, 200 mg/5 mL and 400 mg/5 mL
Approved: December 28, 2006 Aurobindo Pharma Limited - Albuterol Sulfate
Syrup 2 mg (base)/5 mL
Approved: December 27, 2006 Vintage Pharmaceuticals, LLC - Bisoprolol Fumarate
Tablets USP, 5 mg and 10 mg
Approved: December 27, 2006 Aurobindo Pharma Limited - Atenolol Tablets USP,
25 mg, 50 mg, and 100 mg
Approved: December 27, 2006 OHM Laboratories, Inc. - Ondansetron
Injection USP, (Preservative-Free) 2 mg/mL; 2 mL vials
Approved: December 26, 2006 Abraxix Pharmaceutical Products; Apotex Inc.; Baxter Healthcare Corporation; Bedford Laboratories; Hikma Farmaceutica (Portugal), S.A.; Hospira Inc.; Mayne Pharma (USA), Inc.; Pharmaforce, Inc.; Sun Pharmaceutical Industries, Ltd.; Wockhardt Limited - Ondansetron
Injection USP, 2 mg/mL; 20 mL vials
Approved: December 26, 2006 Abraxis Pharmaceutical Products; Apotex Inc.; Baxter Healthcare Corporation; Bedford Laboratories; Hikma Farmaceutica (Portugal), S.A.; Hospira Inc.; Mayne Pharma (USA), Inc.; Pharmaforce, Inc.; Pliva Hrvatska d.o.o.; Sun Pharmaceutical Industries, Ltd.; Wockhardt Limited - Finasteride Tablets
USP, 5 mg
Approved: December 22, 2006 Gedeon Richter Ltd.; Mylan Pharmaceuticals, Inc. (approved 12/18/06); Teva Pharmaceuticals, USA (approved 12/15/06) - Simvastatin Tablets
USP, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg
Approved: December 20, 2006 Aurobindo Pharma Limited; Cobalt Pharmaceuticals, Inc.; Dr. Reddy’s Laboratories Limited (excludes 5 mg); Perrigo R & D Company; Sandoz Inc.; Zydus Pharmaceuticals USA, Inc. - Meloxicam Tablets 7.5
mg and 15 mg
Approved: December 20, 2006 Carlsbad Technology Inc. (approved 12/7/06); Ranbaxy Laboratories Ltd. (approved 12/14/06) ; Unichem Laboratories Limited - Fluconazole for Oral
Suspension 10 mg/mL and 40 mg/mL
Approved: December 18, 2006 Taro Pharmaceutical Industries Ltd. - Ciclopirox
Topical Suspension USP, 0.77%
Approved: December 15, 2006 Perrigo New York, Inc. - Bupropion HCl
Extended-Release Tablets USP, 300 mg
Approved: December 15, 2006 Impax Laboratories, Inc. - Idarubicin Hydrochloride
Injection 1 mg/mL; 5 mL, 10 mL, and 20 mL vials
Approved: December 14, 2006 Bedford Laboratories - Nifedipine
Extended-Release Tablets USP, 30 mg and 60 mg
Approved: December 13, 2006 Abrika Pharmaceuticals, Inc. - Ciprofloxacin
Ophthalmic Solution USP, 0.3%
Approved: December 13, 2006 Nexus Pharmaceuticals, Inc. - Lorazepam Tablets
USP, 0.5 mg, 1 mg, and 2 mg
Approved: December 13, 2006 IVAX Pharmaceuticals Inc. - Cefprozil Tablets
USP, 250 mg and 500 mg
Approved: December 13, 2006 Ranbaxy Laboratories Limited - Triamcinolone
Acetonide Lotion USP, 0.1%
Approved: December 13, 2006 Vintage Pharmaceuticals, LLC - Amantadine Hydrochloride
Oral Solution USP, 50 mg/5 mL
Approved: December 12, 2006 Vintage Pharmaceuticals - Testosterone Cypionate
Injection USP, 200 mg/mL
Approved: December 11, 2006 Synerx Pharma, LLC - Extended Phenytoin Sodium
Capsules USP, 100 mg
Approved: December 11, 2006 Sun Pharmaceutical Industries Ltd -
Promethazine, Phenylephrine, Codeine Oral Solution 6.25 mg/5
mg/10 mg per 5 mL
Approved: December 7, 2006 Vintage Pharmaceuticals, LLC - Promethazine
HCl and Phenylephrine HCl Oral Solution 6.25 mg/5 mg per 5
mL
Approved: December 7, 2006 Vintage Pharmaceuticals, LLC
