Generic Drug Approvals: October 2006

First Time Generic Approvals

• Metronidazole Vaginal Gel, 0.75%
  Approved: October 31, 2006 QLT USA, Inc.
  Generic for: Metrogel Vaginal Gel
• Colestipol Hydrochloride Tablets, 1 g
  Approved: October 24, 2006 Impax Laboratories, Inc.
  Generic for: Colestid Tablets

Other Generic Approvals

• Milrinone Lactate Injection, 1 mg (base)/mL; 5 mL Syringe
  Approved: October 31, 2006 Gland Pharma Limited
• Nicotine Polacrilex Gum USP, (Mint-Flavor) OTC 2 mg and 4 mg (base)/piece
  Approved: October 30, 2006 Perrigo R&D Company
• Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL and 80 mg/mL
  Approved: October 27, 2006 Sicor Pharmaceuticals, Inc.
• Promethazine Hydrochloride Suppositories USP, 12.5 mg and 25 mg
  Approved: October 26, 2006 Taro Pharmaceuticals U.S.A., Inc.
• Pravastatin Sodium Tablets 10 mg, 20 mg, and 40 mg
  Approved: October 23, 2006 Watson Laboratories, Inc., Genpharm Inc., Cobalt Pharmaceuticals, Inc., Dr. Reddy’s Laboratories Limited, Lek Pharmaceuticals d.d., Apotex Inc.
• Zonisamide Capsules, 25 mg, 50 mg, and 100 mg
  Approved: October 16, 2006 Zydus Pharmaceuticals USA,Inc.
• Cefadroxil for Oral Suspension USP, 250 mg/5 mL and 500 mg/5 mL
  Approved: October 16, 2006 Orchid Healthcare
• Valproic Acid Syrup (Valproic Acid Oral Solution, USP), 250 mg/5 mL
  Approved: October 13, 2006 Vintage Pharmaceuticals, LLC
• Ranitidine Tablets USP, 150 mg and 300 mg
  Approved: October 13, 2006 Interpharm Inc.
• Gabapentin Tablets, 100 mg, 300 mg, and 400 mg
  Approved: October 10, 2006 Apotex Inc.
• Ribavirin Tablets, 200 mg
  Approved: October 3, 2006 Sandoz Inc.
• Citalopram Hydrobromide Tablets, 10 mg (base), 20 mg (base), and 40 mg (base)
  Approved: October 3, 2006 Invagen Pharmaceuticals, Inc.
• Meloxicam Tablets, 7.5 mg and 15 mg
  Approved: October 2, 2006 Aurobindo Pharma Limited

Generic Approvals Archive