Generic Drug Approvals for December 2006

Below is the list of Generic Drug Approvals for December 2006. First Time Generics are products that have never been approved before as generics and are new generic products to the marketplace.

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

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