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First-Time Generic Drug Approvals: March 2008

  • Prednisolone Sodium Phosphate Oral Solution, 10 mg (base)/5 mL
    Approved: March 7, 2008 Pharmaceutical Associates, Inc.
    Generic for: Orapred Oral Solution
  • Clobetasol Propionate Foam 0.05%
    Approved: March 10, 2008 Perrigo Israel Pharmaceuticals, Ltd.
    Generic for: Olux Foam
  • Amifostine for Injection USP, 500 mg/vial
    Approved: March 14, 2008 Sun Pharmaceutical Indistries, Ltd.
    Generic for: Ethyol for Injection
  • Ciprofloxacin and Dextrose 5% Injection USP, 2 mg/mL; packaged in 200 mg/100 mL and 400 mg/200 mL Flexible Plastic Containers
    Approved: March 18, 2008 Baxter Healthcare Corporation; ACS Dobfar Info S.A.; Claris Lifesciences Limited; Hospira, Inc.
    Generic for: Cipro I.V. in Dextrose 5% Injection
  • Metronidazole Injection USP 5 mg/mL (100 mL containers)
    Approved: March 31, 2008 Claris Lifescience Ltd.
    Generic for: Flagyl I.V. RTU Injection, 500 mg/100 mL
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