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First-Time Generic Drug Approvals: April 2009

  • Risperidone Orally Disintegrating Tablets 0.25 mg, 0.5 mg, 2 mg, 3 mg and 4 mg
    Approved: April 30, 2009 Kali Laboratories, Inc.
    Generic for: Risperdal-M Tab (Orally Disintegrating Tablet)
  • Mivacurium Chloride Injection 2 mg (base)/mL; packaged in 10 mg (base)/5 mL and 20 mg (base)/10 mL single-dose vials
    Approved: April 30, 2009 Ebewe Parenta Pharmaceuticals, Inc.
    Generic for: Mivacron Injection
  • Azelastine Hydrochloride Nasal Solution (Nasal Spray) 0.1% [125 mcg (base)/spray]
    Approved: April 30, 2009 Apotex Inc.
    Generic for: Astelin Nasal Spray
  • Lorazepam Oral Concentrate USP 2 mg/mL
    Approved: April 28, 2009 Paddock Laboratories, Inc.
    Generic for: Lorazepam Intensol
  • Topiramate Capsules (Sprinkle) 15 mg and 25 mg
    Approved: April 15, 2009 Cobalt Laboratories, Inc.; Barr Laboratories, Inc.
    Generic for: Topamax Sprinkle Capsules

Generic Approvals Archive