CINACALCET HYDROCHLORIDE

213325 | Orange Book

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Filed May 18, 2020
Type Abbreviated New Drug Application
Case Type Abbreviated New Drug Application
Ingredients CINACALCET HYDROCHLORIDE
Dosage Form / Route ORAL and TABLET
Patents No unexpired patents
Last Updated: 4 years, 3 months ago
Date Patent / Filing No. Patent and Drug Application Information
5/18/2020
Approval for CINACALCET HYDROCHLORIDE, EQ 90MG BASE
  • Active Ingredient: CINACALCET HYDROCHLORIDE
  • Dosage Form: TABLET
  • Dosage Route: ORAL
  • Therapeutic Equivalence: Products meeting necessary bioequivalence requirements
5/18/2020
Approval for CINACALCET HYDROCHLORIDE, EQ 60MG BASE
  • Active Ingredient: CINACALCET HYDROCHLORIDE
  • Dosage Form: TABLET
  • Dosage Route: ORAL
  • Therapeutic Equivalence: Products meeting necessary bioequivalence requirements
5/18/2020
Approval for CINACALCET HYDROCHLORIDE, EQ 30MG BASE
  • Active Ingredient: CINACALCET HYDROCHLORIDE
  • Dosage Form: TABLET
  • Dosage Route: ORAL
  • Therapeutic Equivalence: Products meeting necessary bioequivalence requirements
5/18/2020ORIG-1Approval: Label is not available on this site.