Generic Drug Approvals: August 2005

First Time Generic Approvals

• Fexofenadine Hydrochloride Tablets 30 mg, 60 mg, and 180 mg
  Approved: August 31, 2005 Barr Laboratories, Inc.
  Generic for: Allegra Tablets
• Ceftriaxone Injection USP, 1 gram/50 mL and 2 grams/50 mL
  Approved: August 23, 2005 Baxter Healthcare Corporation
  Generic for: Rocephin Injection
• Liothyronine Sodium Injection 10 mcg(base)/mL; 1 mL vials
  Approved: August 17, 2005 Pharmaforce, Inc.
  Generic for: Triostat Injection
• Clonazepam Orally Disintegrating Tablets 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 2 mg
  Approved: August 3, 2005 Kali Laboratories, Inc.
  Generic for: Klonopin Rapidly Disintegrating Tablets

Other Generic Approvals

• Mirtazapine Orally Disintegrating Tablets 15 mg, 30 mg, and 45 mg
  Approved: August 31, 2005 Amide Pharmaceutical, Inc.
• Baclofen Tablets USP 10 mg and 20 mg
  Approved: August 30, 2005 Vintage Pharmaceuticals, LLC
• Cholestyramine for Oral Suspension USP, 4 g Resin/ 9 g Scoopful or Packet
  Approved: August 26, 2005 Par Pharmaceutical, Inc.
• Cholestyramine for Oral Suspension USP, (Light) 4 g Resin/Scoopful or Packet
  Approved: August 26, 2005 Par Pharmaceutical, Inc.
• Clarithromycin Extended-Release Tablets 500 mg
  Approved: August 25, 2005 Sandoz Inc.
• Clarithromycin Tablets USP, 500 mg
  Approved: August 25, 2005 Sandoz Inc.
• Prednisolone Syrup USP, 5 mg/5 mL and 15 mg/5 mL
  Approved: August 25, 2005 Apotex Inc.
• Fluconazole Injection (in 0.9% Sodium Chloride), 2 mg/mL; 100 mL vials
  Approved: August 23, 2005 Hikma Farmaceutica (Portugal), LDA
• Amoxicillin and Clavulanate Potassium Tablets USP, 250 mg/125 mg (Base)
  Approved: August 23, 2005 Sandoz Inc.
• Phenytoin Oral Suspension USP, 125 mg/5 mL
  Approved: August 18, 2005 Vistapharm, Inc.
• Citalopram Hydrobromide Tablets 10 mg, 20 mg and 40 mg (base)
  Approved: August 17, 2005 Sandoz Inc.
• Cephalexin for Oral Suspension USP, 125 mg/5 mL and 250 mg/5 mL
  Approved: August 17, 2005 Lupin Limited
• Fosinopril Sodium and Hydrochlorothiazide Tablets 10 mg/12.5 mg and 20 mg/12.5 mg
  Approved: August 16, 2005 Watson Laboratories, Inc.
• Paroxetine Tablets USP 10 mg, 20 mg, 30 mg, and 40 mg
  Approved: August 15, 2005 Teva Pharmaceuticals USA
• Cefazolin for Injection 1 g/vial and 10 gram/vial (Pharmacy Bulk Package)
  Approved: August 12, 2005 Orchid Healthcare
• Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg and 300 mg (base)
  Approved: August 12, 2005 Lannett Holdings, Inc.
• Methotrexate for Injection USP (Preservative-Free), 1 gram/vial
  Approved: August 12, 2005 Bedford Laboratories
• Clonazepam Orally Disintegrating Tablets 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 2 mg
  Approved: August 10, 2005 Barr Laboratories, Inc.
• Ciclopirox Topical Suspension USP (Lotion), 0.77%
  Approved: August 10, 2005 Taro Pharmaceuticals USA, Inc.
• Clobetasol Propionate Topical Solution USP, 0.05%
  Approved: August 5, 2005 QLT USA, Inc.
• Halobetasol Proprionate Cream 0.05%
  Approved: August 4, 2005 Taro Pharmaceuticals USA Inc.
• Loxapine Capsules USP, 5 mg, 10 mg, 25 mg and 50 mg (base)
  Approved: August 4, 2005 Amide Pharmaceutical, Inc.
• Hydrocortisone Butyrate Cream USP, 0.1%
  Approved: August 3, 2005 Taro Pharmaceutical Industries Ltd.
• Ceftriaxone for Injection USP, 250 mg/vial, 500 mg/vial, 1 g/vial, 2 g/vial and 10 g/vial Pharmacy Bulk Package
  Approved: August 2, 2005 Orchid Healthcare

Generic Approvals Archive