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

Generic Approvals Archive