Generic Drug Approvals: June 2005

First Time Generic Approvals

• Carbidopa and Levodopa Tablets For Oral Suspension 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg
  Approved: June 6, 2005 Company: Ranbaxy Laboratories Limited
  Generic for: Sinemet Tablets

Other Generic Approvals

• Citalopram Hydrobromide Tablets 10 mg (base), 20 mg (base), and 40 mg (base)
  Approved: June 30, 2005 Company: Cobalt Pharmaceuticals, Inc.
• Gabapentin Capsules 100 mg, 300 mg, and 400 mg
  Approved: June 30, 2005 Comapny: Mutual Pharmaceutical Company, Inc.
• Metformin Hydrochloride Extended-Release Tablets 750 mg
  Approved: June 29, 2005 Company: Ranbaxy Laboratories Limited
• Propoxyphene Napsylate and Acetaminophen Tablets USP, 100 mg/500 mg
  Approved: June 28, 2005 Company: Andrx Pharmaceuticals, LLC
  
• Mirtazapine Orally Disintegrating Tablets 15 mg, 30 mg, and 45 mg
  Approved: June 28, 2005 Company: Teva Pharmaceuticals USA
• Glyburide and Metformin Hydrochloride Tablets 1.25 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg
  Approved: June 28, 2005 Company: Purepac Pharmaceutical Co.
• Cephalexin Capsules USP, 250 mg and 500 mg
  Approved: June 28, 2005 Company: Orchid Healthcare
• Nystatin Oral Suspension USP, 100,000 Units/mL
  Approved: June 28, 2005 Company: Vintage Pharmaceuticals, LLC
• Haloperidol Decanoate Injection 50 mg (base)/mL and 100 mg (base)/mL
  Approved: June 24, 2005 Company: Sabex 2002 Inc.
• Ibuprofen Tablets USP, (OTC), 200 mg Orange-Coated, Round & Capsule-Shaped
  Approved: June 21, 2005 Company: Perrigo R&D Company
• Cromolyn Sodium Inhalation Solution USP, 10 mg/mL; packaged in 20 mg/2 mL Single- Dose Ampules
  Approved: June 17, 2005 Company: Breath Limited
• Levothyroxine Sodium Tablets USP, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.15 mg, 0.175 mg, 0.2 mg, and 0.3 mg
  Approved: June 16, 2005 Company: Genpharm Inc.
• Clotrimazole & Betamethasone Dipropionate Lotion USP, 1%/0.05%(base)
  Approved: June 16, 2005 Company: Altana Inc.
• Ciprofloxacin Tablets USP, 100 mg, 250 mg, 500 mg, and 750 mg
  Approved: June 15, 2005 Company: Pliva, Inc.
• Fluticasone Propionate Ointment 0.005%
  Approved: June 14, 2005 Company: Taro Pharmaceutical Industries, Ltd.
• Halobetasol Propionate Ointment 0.05%
  Approved: June 14, 2005 Company: Alpharma USPD Inc.
• Carboplatin Injection 10 mg/mL; packaged in 50 mg/5 mL, 150 mg/15 mL, and 450 mg/45 mL Multiple-Dose Vials
  Approved: June 14, 2005 Company: Spectrum Pharmaceuticals, Inc.
• Folic Acid Tablets USP, 1 mg
  Approved: June 14, 2005 Company: Trigen Laboratories, Inc.
• Acyclovir Oral Suspension USP, 200 mg/5 mL
  Approved: June 7, 2005 Company: Hi-Tech Pharmacal Co., Inc.
• Carisoprodol Tablets USP, 350 mg
  Approved: June 7, 2005 Company: Neil Laboratories, Inc.
• Prednisone Tablets USP, 1 mg
  Approved: June 6, 2005 Company: Trigen Laboratories, Inc.
• Vinorelbine Tartrate Injection, 10 mg (base)/mL; packaged in 10 mg (base)/1 mL and 50 mg (base)/5 mL Single-Use Vials
  Approved: June 2, 2005 Company: Mayne Pharma (USA), Inc.
• Bethanechol Chloride Tablets USP, 5 mg, 10 mg, 25 mg and 50 mg
  Approved: June 1, 2005 Company: Upsher-Smith Laboratories, Inc.

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