DEFERASIROX

213374 | Orange Book

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Filed July 14, 2020
Type Abbreviated New Drug Application
Case Type Abbreviated New Drug Application
Ingredients DEFERASIROX
Dosage Form / Route ORAL and GRANULE
Patents No unexpired patents
Last Updated: 4 years, 1 month ago
Date Patent / Filing No. Patent and Drug Application Information
7/14/2020
Approval for DEFERASIROX, 360MG
  • Active Ingredient: DEFERASIROX
  • Dosage Form: GRANULE
  • Dosage Route: ORAL
  • Therapeutic Equivalence: Products meeting necessary bioequivalence requirements
7/14/2020
Approval for DEFERASIROX, 180MG
  • Active Ingredient: DEFERASIROX
  • Dosage Form: GRANULE
  • Dosage Route: ORAL
  • Therapeutic Equivalence: Products meeting necessary bioequivalence requirements
7/14/2020
Approval for DEFERASIROX, 90MG
  • Active Ingredient: DEFERASIROX
  • Dosage Form: GRANULE
  • Dosage Route: ORAL
  • Therapeutic Equivalence: Products meeting necessary bioequivalence requirements
7/14/2020ORIG-1Approval: Label is not available on this site.