Drug application

VORTIOXETINE (VORTIOXETINE)

Drugs@FDA ANDA 211066 · ALEMBIC PHARMS LTD

Key facts

Drug name VORTIOXETINE
Active ingredients VORTIOXETINE
Application type ANDA
Application number 211066
Company ALEMBIC PHARMS LTD
Dosage forms TABLET, ORAL
Strength 10MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Jan 5, 2022

At a glance

  • 1–9 Submissions
  • None Label versions
  • None 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:

Browse all Drugs@FDA applications