First-Time Generic Drug Approvals: June 2008

  • Zaleplon Capsules 5 mg and 10 mg
    Approved: June 6, 2008 Sandoz Inc.; Genpharm ULC; Unichem Laboratories Limited; Aurobindo Pharma Limited; Upsher-Smith Laboratories, Inc.; Teva Pharmaceuticals USA; Roxane Laboratories, Inc.
    Generic for: Sonata Capsules
  • Prednisolone Sodium Phosphate Oral Solution 20 mg (base)/5 mL (new strength)
    Approved: June 9, 2008 Pharmaceutical Associates, Inc.
    Generic for: Orapred Oral Solution
  • Ciclopirox Gel 0.77%
    Approved: June 10, 2008 Nycomed US, Inc.
    Generic for: Loprox Gel
  • Torsemide Injection 10 mg/mL; 2 mL and 5 mL vials
    Approved: June 10, 2008 Bedford Laboratories
    Generic for: Demadex Injection, 10 mg/mL
  • Dronabinol Capsules USP, 2.5 mg, 5 mg, and 10 mg
    Approved: June 27, 2008 Par Pharmaceutical, Inc.
    Generic for: Marinol Capsules, 2.5 mg, 5 mg, 10 mg
  • Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg
    Approved: June 30, 2008 Teva Pharmaceuticals USA
    Generic for: Risperdal Tablets
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