First-Time Generic Drug Approvals: November 2008

  • Rocuronium Bromide Injection 10 mg/mL packaged in 5 mL and 10 mL Multiple-Dose Vials
    Approved: November 26, 2008 Hospira Inc.; Teva Parenteral Medicines, Inc.; Generamedix, Inc.
    Generic for: Zemuron Injection
  • Methylergonovine Maleate Injection USP 0.2 mg/mL
    Approved: November 24, 2008 Pharmaforce, Inc.
    Generic for: Methergine
  • Budesonide Inhalation Suspension 0.25 mg/2 mL and 0.5 mg/2 mL; packaged in Unit-Dose Vials
    Approved: November 18, 2008 IVAX Pharmaceuticals
    Generic for: Pulmicort Respules Inhalation Suspension
  • Calcitonin-Salmon Nasal Spray 200 IU/Spray
    Approved: November 17, 2008 Apotex, Inc.
    Generic for: Miacalcin Nasal Spray
  • Levetiracetam Tablets 250 mg, 500 mg and 750 mg
    Approved: November 3, 2008 Mylan Pharmaceuticals, Inc.
    Generic for: Keppra Tablets
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