Drug application

VORTIOXETINE HYDROBROMIDE (VORTIOXETINE HYDROBROMIDE)

Drugs@FDA ANDA 211101 · MSN LABORATORIES PRIVATE LTD

Key facts

Drug name VORTIOXETINE HYDROBROMIDE
Active ingredients VORTIOXETINE HYDROBROMIDE
Application type ANDA
Application number 211101
Company MSN LABORATORIES PRIVATE LTD
Dosage forms TABLET, ORAL
Strength 10MG
Marketing status None (Tentative Approval)
Reference listed drug No
Latest submission status date Nov 3, 2025

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • None Therapeutic equivalents

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

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