Drug application

INGREZZA (VALBENAZINE TOSYLATE)

Drugs@FDA NDA 209241 · NEUROCRINE

Key facts

Drug name INGREZZA
Active ingredients VALBENAZINE TOSYLATE
Application type NDA
Application number 209241
Company NEUROCRINE
Dosage forms CAPSULE, ORAL
Strength EQ 40MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity
Latest submission status date Apr 11, 2017

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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