Generic Drug Approvals: April 2005

First Time Generic Approvals

• Estradiol and Estradiol/Norgestimate Tablets 1 mg and 1 mg/0.09 mg
  Approved: April 29, 2005 Company: Barr Laboratories, Inc.
  Generic for: Prefest Tablets
• Niacin Extended-Release Tablets 500 mg and 750 mg
  Approved: April 26, 2005 Company: Barr Laboratories, Inc.
  Generic for: Niaspan Extended-Release Tablets
• Clozapine Tablets USP 50 mg (New Strength)
  Approved: April 25, 2005 Company: Ivax Pharmaceuticals, Inc.
  Generic for: Clozaril Tablets
• Tramadol Hydrochloride and Acetaminophen Tablets 37.5 mg/325 mg
  Approved: April 21, 2005 Company: Kali Laboratories, Inc.
  Generic for: Ultracet Tablets
• Anagrelide Hydrochloride Capsules 0.5 mg (base) and 1 mg (base)
  Approved: April 18, 2005 Company: Impax Laboratories, Inc., Ivax Pharmaceuticals, Inc., Roxane Laboratories, Inc., Watson Laboratories, Inc., Barr Laboratories, Inc., Eon Labs, Inc., Mylan Pharmaceuticals, Inc.
  Generic for: Agrylin Capsules
• Niacin Extended-Release Tablets 1000 mg
  Approved: April 18, 2005 Company: Barr Laboratories, Inc.
  Generic for: Niaspan Tablets
• Fexofenadine HCl & Pseudoephedrine HCl ER 60 mg/120 mg
  Approved: April 14, 2005 Company: Barr Laboratories, Inc.
  Generic for: Allegra D Extended-Release Tablets
• Octreotide Acetate Injection 0.2 mg/mL (base) 1 mg/mL (base)
  Approved: April 8, 2005 Company: Bedford Laboratories
  Generic for: Sandostatin Injection
• Mometasone Furoate Topical Solution USP 0.1%
  Approved: April 6, 2005 Company: Aigis Industries Ltd.
  Generic for: Elocon Topical Lotion

Other Generic Approvals

• Citalopram Hydrobromide Tablets 10 mg, 20 mg, and 40 mg (base)
  Approved: April 29, 2005 Company: Akyma Pharmaceuticals, LLC
• Norethindrone/Ethinyl Estradiol and Ferrous Fumarate Tablets USP 1.5 mg/0.03 mg/75 mg
  Approved: April 28, 2005 Company: Andrx Pharmaceuticals, LLC
• Naproxen Tablets USP 250 mg, 375 mg, and 500 mg
  Approved: April 27, 2005 Company: Perrigo R&D Company
• Adenosine Injection USP 3 mg/mL; packaged in 6 mg/2 mL and 12 mg/4 mL single-use vials
  Approved: April 27, 2005 Company: American Pharmaceutical Partners
• Clozapine Tablets USP 25 mg and 100 mg
  Approved: April 26, 2005 Company: Teva Pharmaceuticals USA
• Prednisolone Sodium Phosphate Oral Solution 15 mg (base)/5 mL
  Approved: April 25, 2005 Company: Pharmaceutical Associates, Inc.
• Dexamethasone Sodium Phosphate Injection USP 10 mg/mL (Preserved) Multiple-Dose Vials
  Approved: April 22, 2005 Company: American Pharmaceutical Partners
• Metformin Hydrochloride Extended-Release Tablets 750 mg
  Approved: April 21, 2005 Company: Zydus Pharmaceuticals USA, Inc.
• Cefazolin for Injection USP 500 mg/vial and 1 g/vial
  Approved: April 21, 2005 Company: Orchid Healthcare
• Fosinopril Sodium Tablets 10 mg, 20 mg, and 40 mg
  Approved: April 20, 2005 Company: Invagen Pharmaceuticals, Inc.
• Amiodarone Hydrochloride Injection 50 mg/mL
  Approved: April 20, 2005 Company: Apotex Corp.
• Metformin Hydrochloride Extended-Release Tablets 500 Mg
  Approved: April 20, 2005 Company: Zydus Pharmaceuticals USA Inc.
• Propofol Injectable Emulsion 10 mg/mL; packaged in 20 mL, 50 mL, and 100 mL Single-Dose Vials
  Approved: April 19, 2005 Company: Bedford Laboratories
• Metformin Hydrochloride Tablets 500 mg, 850 mg, and 1000 mg
  Approved: April 18, 2005 Company: Zydus Pharmaceuticals USA, Inc.
• Vinorelbine Tartrate Injection 10 mg (base)/mL; packaged in 1 mL and 5 mL Single-Use Vials
  Approved: April 18, 2005 Company: American Pharmaceutical Partners
• Phentermine Hydrochloride Tablets USP 37.5 mg
  Approved: April 15, 2005 Company: Lannett Holdings, Inc.
• Metformin Hydrochloride Extended-Reaease Tablets 750 mg
  Approved: April 13, 2005 Company: Purepac Pharmaceutical Co
• Metformin Hydrochloride Extended-Release Tablets 750 mg
  Approved: April 12, 2005 Company: Andrx Pharmaceuticals, LLC, Teva Pharmaceuticals USA
• Ciclopirox Olamine Cream USP 0.77%
  Approved: April 12, 2005 Company: Taro Pharmaceuticals USA, Inc.
• Ketoconazole Shampoo 2 %
  Approved: April 11, 2005 Company: QLT USA, Inc.
  
• Amiodarone Hydrochloride Tablets 200 mg and 400 mg
  Approved: April 8, 2005 Company: Aurosal Pharmaceuticals, LLC.
• Mometasone Furoate Cream USP 0.1%
  Approved: April 8, 2005 Company: Altana Inc.
• Gabapentin Capsules 100 mg, 300 mg, and 400 mg
  Approved: April 6, 2005 Company: Eon Pharma, LLC; Apotex Inc.
  
• Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
  Approved: April 5, 2005 Company: Eon Labs, Inc.
• Bromocriptine Mesylate Capsules USP 5 mg (base)
  Approved: April 4, 2005 Company: Mylan Pharmaceuticals, Inc.

Generic Approvals Archive