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First-Time Generic Drug Approvals: November 2019

  • Gadoterate Meglumine Injection (Clariscan) 5 mmol /10 mL, 7.5 mmol/15 mL and 10 mmol/20 mL Single-Dose Vials
    Approved: November 1, 2019 - GE Healthcare Inc.
    Generic for: Dotarem
  • Mesalamine Extended-Release Capsules, USP 0.375 g
    Approved: November 1, 2019 - Mylan Pharmaceuticals Inc.
    Generic for: Apriso
  • Deferasirox Tablets 90 mg, 180 mg and 360 mg
    Approved: November 20, 2019 - Alembic Pharmaceuticals Limited; MSN Pharmaceuticals, Inc.; Teva Pharmaceuticals USA, Inc.; Zydus Pharmaceuticals (USA), Inc.
    Generic for: Jadenu

Generic Approvals Archive