Generic Drug Approvals: August 2006

First Time Generic Approvals

• Lamotrigine Tablets 25 mg, 100 mg, 150 mg, and 200 mg
  Approved: August 30, 2006 Teva Pharmaceuticals USA
  Generic for: Lamictal Tablets
• Ciprofloxacin Injection USP, 10 mg/mL; 1200 mg/120 mL single-use vial; Pharmacy Bulk Package
  Approved: August 28, 2006 Bedford Laboratories
  Generic for: Cipro I.V. Injection
• Ciprofloxacin Injection USP, 10 mg/mL; packaged in 200 mg/20 mL and 400 mg/40 mL single-dose vials
  Approved: August 28, 2006 Bedford Laboratories; Hospira Inc.; Sicor Pharmaceuticals, Inc.; Abraxis Pharmaceutical Products
  Generic for: Cipro I.V. Injection
• Venlafaxine Hydrochloride Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base), and 100 mg (base)
  Approved: August 3, 2006 Teva Pharmaceuticals USA
  Generic for: Effexor Tablets
• Trimipramine Maleate Capsules 25 mg (base), 50 mg (base), and 100 mg (base)
  Approved: August 2, 2006 Amide Pharmaceutical, Inc.
  Generic for: Surmontil Capsules

Other Generic Approvals

• Fosinopril Sodium Tablets 10 mg, 20 mg, and 40 mg
  Approved: August 31, 2006 Cobalt Pharmaceuticals, Inc.
• Glycopyrrolate Tablets 1 mg and 2 mg
  Approved: August 31, 2006 Kali Laboratories, Inc.
• Cefotaxime for Injection USP, 1 gram/vial
  Approved: August 29, 2006 Wockhardt Limited
• Spironolactone Tablets USP, 25 mg, 50 mg, and 100 mg
  Approved: August 29, 2006 Vintage Pharmaceuticals, LLC
• Metoclopramide Tablets USP, 5 mg and 10 mg
  Approved: August 28, 2006 Vintage Pharmaceuticals, LLC
• Citalopram Hydrobromide Oral Solution 10 mg (base)/5 mL
  Approved: August 28, 2006 Aurobindo Pharma Limited
• Hydrocodone Bitartrate and Acetaminophen Tablets USP, 7.5 mg/750 mg
  Approved: August 28, 2006 Interpharm Inc.
• Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/325 mg, 5 mg/500 mg, 7.5 mg/500 mg, 7.5 mg/650 mg, 10 mg/325 mg, 10 mg/650 mg
  Approved: August 25, 2006 Interpharm Inc.
• Gabapentin Tablets 600 mg and 800 mg
  Approved: August 24, 2006 Sun Pharmaceutical Industries Ltd.
• Gabapentin Capsules 100 mg, 300 mg, and 400 mg
  Approved: August 24, 2006 Sun Pharmaceutical Industries Ltd.
• Metformin Hydrochloride Tablets USP, 500 mg, 850 mg, and 1000 mg
  Approved: August 23, 2006 Dr. Reddy’s Laboratories Ltd.
• Gabapentin Tablets 600 mg and 800 mg
  Approved: August 18, 2006 Glenmark Pharmaceuticals Limited
• Nystatin Topical Powder USP, 100,000 Units/gram
  Approved: August 18, 2006 KV Pharmaceutical Company
• Norgestimate and Ethinyl Estradiol Tablets 0.25 mg/0.035 mg, Packaged in a 28-Day Cycle Regimen
  Approved: August 17, 2006 Watson Laboratories, Inc.
• Norgestimate and Ethinyl Estradiol Tablets 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg, respectively; Packaged in a 28-Day Cycle Regimen
  Approved: August 17, 2006 Watson Laboratories, Inc.
• Zonisamide Capsules 25 mg, 50 mg, and 100 mg
  Approved: August 16, 2006 Banner Pharmacaps, Inc.
• Baclofen Tablets USP, 10 mg and 20mg
  Approved: August 14, 2006 Caraco Pharmaceutical Laboratories, Ltd.
• Fosinopril Sodium and Hydrochlorothiazide Tablets 10 mg/12.5 mg and 20 mg/12.5 mg
  Approved: August 14, 2006 Genpharm Inc.
• Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP, 200 mg/30 mg (OTC)
  Approved: August 14, 2006 Dr. Reddy’s Laboratories Limited
• Sertraline Hydrochloride Tablets 25 mg (base), 50 mg (base), and 100 mg (base)
  Approved: August 11, 2006 Teva Pharmaceuticals USA
• Cefotaxime for Injection USP, 500 mg (base)/vial, 1 g (base)/vial, and 2 g (base)/vial
  Approved: August 11, 2006 Orchid Healthcare
• Cefotaxime for Injection USP, 1 g (base)/vial and 2 g (base)/vial Packaged in Infusion Bottles
  Approved: August 10, 2006 Orchid Healthcare
• Cefotaxime for Injection USP, 10 g (base)/vial (Pharmacy Bulk Package)
  Approved: August 10, 2006 8/10/2006
• Testosterone Cypionate Injection USP, 100 mg/mL and 200 mg/mL
  Approved: August 10, 2006 Sandoz Canada, Inc.
• Fentanyl Transdermal System 25 mcg/hour, 50 mcg/hour, 75 mcg/hour, and 100 mcg/hour
  Approved: August 4, 2006 Lavipharm Laboratories, Inc.
• Flunisolide Nasal Solution USP, 0.025% (0.025 mg/Spray) Metered Nasal Spray
  Approved: August 3, 2006 Q-Pharma LLC

Generic Approvals Archive