Generic Drug Approvals: July 2005

First Time Generic Approvals

• Rifampin and Isoniazid Capsules USP, 300 mg/150 mg
  Approved: July 29, 2005 Company: West-Ward Pharmaceutical Corp.
  Generic for: Rifamate Capsules
• Fexofenadine Hydrochloride Capsules 60 mg
  Approved: July 13, 2005 Company: Barr Laboratories, Inc.
  Generic for: Allegra Capsules
• Alclometasone Dipropionate Cream USP, 0.05%
  Approved: July 12, 2005 Company: Altana Inc.
  Generic for: Aclovate Cream
• Isoniazid Injection USP, 100 mg/mL; Packaged In 10 Ml Multiple-Dose Vials
  Approved: July 7, 2005 Company: Sabex 2002 Inc.
  Generic for: Nydrazid Injection
• Desmopressin Acetate Tablets, 0.1 mg and 0.2 mg
  Approved: July 1, 2005 Company: Barr Laboratories, Inc.
  Generic for: DDAVP Tablets

Other Generic Approvals

• Baclofen Tablets USP, 10 mg and 20 mg
  Approved: July 29, 2005 Company: Alphapharm Pty. Ltd.
• Valproic Acid Syrup USP, 250 mg/5 mL
  Approved: July 29, 2005 Company: Apotex Inc.
• Desogestrel and Ethinyl Estradiol Tablets 0.15 mg/0.03 mg; 28-Day
  Approved: July 29, 2005 Company: Watson Laboratories, Inc.
• Cefuroxime Axetil Tablets USP, 125 mg (Base), 250 mg (Base), and 500 mg (Base)
  Approved: July 29, 2005 Company: Wockhardt Limited
• Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg
  Approved: July 29, 2005 Company: Mutual Pharmaceutical Company, Inc.
• Famotidine Tablets USP, 20 mg and 40 mg
  Approved: July 27, 2005 Company: Perrigo R&D Company
• Ranitidine Tablets USP, 150 mg and 300 mg
  Approved: July 27, 2005 Company: Dr. Reddy’s Laboratories Limited
• Folic Acid Tablets USP, 1 mg
  Approved: July 21, 2005 Company: Pharmax Group, Inc.
• Milrinone Lactate in 5% Dextrose Injection 20 mg (Base)/100 mL; 100 mL and 200 mL
  Approved: July 20, 2005 Company: Apotex Corp.
• Ipratropium Bromide Inhalation Solution 0.02%; 2.5 mL Unit-Dose Vials
  Approved: July 19, 2005 Company: Rxelite
• Ibuprofen Tablets USP, 400 mg, 600 mg, and 800 mg
  Approved: July 18, 2005 Company: Perrigo R&D Company
• Folic Acid Tablets USP, 1 mg
  Approved: July 18, 2005 Company: Mutual Pharmaceutical Company, Inc.
• Bupropion Hydrochloride Extended-Release Tablets USP, 100 mg and 150 mg
  Approved: July 14, 2005 Company: Sandoz Inc.
• Lorazepam Injection USP, 2 mg/mL and 4 mg/mL; 10 mL Multiple-Dose Vials
  Approved: July 13, 2005 Company: Bedford Laboratories
• Lorazepam Injection USP (Preservative-Free), 2 mg/mL and 4 mg/mL; 1 mL Single-Dose Vials
  Approved: July 13, 2005 Company: Bedford Laboratories
• Hydrochlorothiazide Capsules 12.5 mg
  Approved: July 13, 2005 Company: IVAX Pharmaceuticals, Inc.
• Amoxicillin Tablets USP, 500 mg and 875 mg
  Approved: July 13, 2005 Company: Sandoz Inc.
• Methadone Hydrochloride Tablets USP, Diskets, Dispersible 40 mg
  Approved: July 12, 2005 Company: Mallinckrodt Inc.
• Methimazole Tablets USP, 15 mg
  Approved: July 12, 2005 Company: Cedar Pharmaceuticals LLC
• Diphenhydramine Hydrochloride Injection USP, 50 mg/mL; 10 mL Multiple-Dose Vials
  Approved: July 12, 2005 Company: Bioniche Pharma
• Mercaptopurine Tablets USP, 50 mg
  Approved: July 1, 2005 Company: Mylan Pharmaceuticals, Inc.

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