First-Time Generic Drug Approvals: August 2009

• Azelastine Hydrochloride Ophthalmic Solution 0.05%
  Approved: August 3, 2009 Apotex Inc.
  Generic for: Optivar Ophthalmic Solution
• Oxaliplatin Injection 5 mg/mL; (preservative-free), packaged in 50 mg/10 mL and 100 mg/20 mL single-use vials
  Approved: August 7, 2009 Hospira Worldwide; Sun Pharma Global; Fresenius Kabi Oncology
  Generic for: Eloxatin Injection
• Tacrolimus Capsules 0.5 mg, 1 mg and 5 mg
  Approved: August 10, 2009 Sandoz, Inc.
  Generic for: Prograf Capsules
• Clindamycin Phosphate and Benzoyl Peroxide Gel 1% (base)/5%
  Approved: August 11, 2009 Dow Pharmaceutical Sciences, Inc.
  Generic for: Benzaclin Topical Gel
• Aspirin and Dipyridamole Extended-Release Capsules 25 mg/200 mg
  Approved: August 14, 2009 Barr Laboratories, Inc.
  Generic for: Aggrenox Extended-Release Capsules
• Clonidine Transdermal System USP 0.1 mg/day, 0.2 mg/day and 0.3 mg/day
  Approved: August 18, 2009 Aveva Drug Delivery Systems, Inc.
  Generic for: Catapres-TTS
• Levonorgestrel Tablets (Rx/OTC) 0.75 mg
  Approved: August 28, 2009 Watson Laboratories, Inc.
  Generic for: Plan B Tablets

Generic Approvals Archive