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First-Time Generic Drug Approvals: October 2009

  • Buprenorphine Hydrochloride Sublingual Tablets 2 mg (base) and 8 mg (base)
    Approved: October 8, 2009 Roxane Laboratories, Inc.
    Generic for: Subutex
  • Chlorothiazide Sodium for Injection, USP 500 mg (base)/vial
    Approved: October 16, 2009 APP Pharmaceuticals, Inc.
    Generic for: Diuril for Injection

Generic Approvals Archive