Generic Drug Approvals: September 2005

First Time Generic Approvals

• Zidovudine Oral Solution USP, 50 mg/5 mL
  Approved: September 19, 2005 Aurobindo Pharma Limited
  Generic for: Retrovir Syrup
• Zidovudine Tablets USP 300 mg
  Approved: September 19, 2005 Aurobindo Pharma/Roxane/Ranbaxy
  Generic for: Retrovir Tablets
• Tretinoin Cream USP (Emollient), 0.05%
  Approved: September 15, 2005 Spear Pharmaceuticals
  Generic for: Renova Cream
• Leflunomide Tablets 10 mg and 20 mg
  Approved: September 13, 2005 Barr Laboratories, Inc.
  Generic for: Arava Tablets

Other Generic Approvals

• Acyclovir Tablets USP, 400 mg and 800 mg
  Approved: September 29, 2005 Apotex Inc.
• Primidone Tablets USP, 50 mg and 250 mg
  Approved: September 29, 2005 Mutual Pharmaceutical Company, Inc.
• Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 120 mg
  Approved: September 28, 2005 Ranbaxy Laboratories Limited
• Danazol Capsules USP, 200 mg
  Approved: September 28, 2005 Lannett Holdings, Inc.
• Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg and 20 mg/12.5 mg
  Approved: September 28, 2005 Sandoz Inc.
• Fluconazole Tablets 50 mg, 100 mg, and 200 mg
  Approved: September 28, 2005 Unique Pharmaceutical Laboratories
  
• Acyclovir Capsules USP, 200 mg
  Approved: September 28, 2005 Apotex Inc.
• Mupirocin Ointment USP, 2 %
  Approved: September 23, 2005 Taro Pharmaceuticals U.S.A., Inc.
• Carboplatin Injection 10 mg/mL; 5 mL, 15 mL, 45 mL, and 60 mL Vials
  Approved: September 21, 2005 Sicor Pharmaceuticals, Inc.
• Ergotamine Tartrate and Caffeine Tablets USP 1 mg/100 mg
  Approved: September 16, 2005 Mikart, Inc.
• Nizatidine Capsules USP, 150 mg and 300 mg
  Approved: September 15, 2005 Dr. Reddy’s Laboratories Limited
• Alclometasone Dipropionate Cream USP, 0.05%
  Approved: September 15, 2005 Taro Pharmaceuticals USA, Inc.
• Gabapentin Tablets 600 mg and 800 mg
  Approved: September 14, 2005 Ranbaxy Laboratories Limited
• Leflunomide Tablets 10 mg and 20 mg
  Approved: September 13, 2005 Apotex/Sandoz/Kali Labs/Teva
  
• Metformin Hydrochloride Extended-Release Tablets 750 mg
  Approved: September 13, 2005 Impax Laboratories, Inc.
• Metformin Hydrochloride Extended-Release Tablets 500 mg
  Approved: September 13, 2005 Mylan Pharmaceuticals, Inc.
• Lisinopril Tablets USP 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg
  Approved: September 9, 2005 Lupin Limited
• Midazolam Hydrochloride Syrup 2 mg (base)/mL
  Approved: September 9, 2005 Apotex Inc.
• Benazepril Hydrochloride and Hydrochlorothiazide Tablets 5 mg/6.25 mg, 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg
  Approved: September 8, 2005 Ranbaxy Laboratories Limited
• Allopurinol Tablets USP 100 mg and 300 mg
  Approved: September 8, 2005 Apotex Inc.
• Metformin Hydrochloride Extended-Release Tablets 750 mg
  Approved: September 8, 2005 Mylan Pharmaceuticals, Inc.
• Fexofenadine Hydrochloride Tablets 30 mg, 60 mg, and 180 mg
  Approved: September 1, 2005 Teva Pharmaceuticals, USA

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