Generic Drug Approvals: May 2005

First Time Generic Approvals

• Foscarnet Sodium Injection 24 mg/mL; 250 mL and 500 mL Bottles
  Approved: May 31, 2005 Company: Pharmaforce, Inc.
  Generic for: Foscavir Injection
• Ceftriaxone for Injection USP, 10 g/vial (Pharmacy Bulk Package)
  Approved: May 17, 2005 Company: Sandoz, Inc.
  Generic for: Rocephin For Injection (PBP)
• Fenofibrate Tablets 54 mg and 160 mg
  Approved: May 13, 2005 Company: Teva Pharmaceuticals USA
  Generic for: Tricor Tablets
• Doxycycline Hyclate Capsules USP, 20 mg
  Approved: May 13, 2005 Company: West-Ward Pharmaceutical Corp.
  Generic for: Periostat Capsules
• Doxycycline Hyclate Tablets USP, 20 mg
  Approved: May 13, 2005 Company: Ivax Pharmaceuticals, Inc.
  Generic for: Periostat Tablets
• Doxycycline Hyclate Tablets USP, 20 mg
  Approved: May 13, 2005 Company: Mutual Pharmaceutical Company, Inc.
  Generic for: Periostat Tablets

Other Generic Approvals

• Torsemide Tablets 5 mg, 10 mg, 20 mg, and 100 mg
  Approved: May 31, 2005 Company: Apotex Inc.
• Clarithromycin Tablets USP, 250 mg and 500 mg
  Approved: May 31, 2005 Company: Teva Pharmaceuticals USA; Ivax Pharmaceuticals, Inc.
• Hydroxyzine Hydrochloride Tablets USP, 10 mg, 25 mg and 50 mg
  Approved: May 27, 2005 Company: Vintage Pharmaceuticals, LLC
• Prednisolone Sodium Phosphate Oral Solution 5 mg (base)/5 mL and 15 mg (base)/5 mL
  Approved: May 24, 2005 Company: KV Pharmaceutical Company
• Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1 mg/35 mcg; packaged in 28-day regimens
  Approved: May 23, 2005 Company: Barr Laboratories, Inc.
• Norethindrone Acetate and Ethinyl Estradiol Tablets USP, and Ferrous Fumarate Tablets 1 mg/0.02 mg/75 mg
  Approved: May 20, 2005 Company: Andrx Pharmaceuticals, LLC
• Fluoxetine Capsules USP, 40 mg
  Approved: May 18, 2005 Company: Barr Laboratories, Inc.
• Clarithromycin Extended-Release Tablets 500 mg
  Approved: May 18, 2005 Company: Teva Pharmaceuticals USA
• Cilostazol Tablets 50 mg and 100 mg
  Approved: May 17, 2005 Company: Roxane Laboratories, Inc.
• Fosinopril Sodium Tablets 10 mg, 20 mg, and 40 mg
  Approved: May 17, 2005 Company: Apotex Inc.
• Doxycycline Hyclate Tablets USP, 20 mg
  Approved: May 13, 2005 Company: Corepharma LLC
• Ipratropium Bromide Inhalation Solution 0.02%; 0.5 mg/2.5 mL vials
  Approved: May 9, 2005 Company: Breath Limited
• Ceftriaxone for Injection USP, 250 mg, 500 mg, 1 g, and 2 g vials
  Approved: May 9, 2005 Company: Sandoz, Inc.
• Flumazenil Injection USP, 0.1 mg/mL; 5 mL and 10 mL vials
  Aapproved: May 3, 2005 Company: Sabex 2002 Inc.
• Ceftriaxone for Injection USP, 1 g and 2 g vials
  Approved: May 3, 2005 Company: Sandoz, Inc.
• Nystatin Topical Powder USP, 100,000 units/gram
  Approved: May 3, 2005 Company: Upsher-Smith Laboratories, Inc.
• Clonazepam Tablets USP 0.5 mg, 1 mg, and 2 mg
  Approved: May 2, 2005 Company: Kali Laboratories, Inc.
• Esmolol Hydrochloride Injection 10 mg/mL; 10 mL vials
  Approved: May 2, 2005 Company: American Pharmaceutical Partners, Inc.; Pharmaforce, Inc.
• Midazolam Hydrochloride Syrup 2 mg (base)/mL
  Approved: May 2, 2005 Company: Paddock Laboratories, Inc.

Generic Approvals Archive