Drug application

VALBENAZINE (VALBENAZINE)

Drugs@FDA ANDA 215962 · SANDOZ INC

Key facts

Drug name VALBENAZINE
Active ingredients VALBENAZINE
Application type ANDA
Application number 215962
Company SANDOZ INC
Dosage forms CAPSULE, ORAL
Strength 40MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Dec 12, 2022

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No 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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