Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsORALGeneric

TRINTELLIX

VORTIOXETINE HYDROBROMIDE

Standard Dose
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Discontinued
Summary

Approval overview TRINTELLIX is listed in Drugs@FDA under application 204447 (NDA).

Review priority: PRIORITY Marketing status: Discontinued Active ingredient VORTIOXETINE HYDROBROMIDE Form and strength TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor TAKEDA PHARMS USA Submission history Latest submission status date: 2023-08-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview TRINTELLIX is listed in Drugs@FDA under application 204447 (NDA). Review priority: PRIORITY Marketing status: Discontinued Active ingredient VORTIOXETINE HYDROBROMIDE Form and strength TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor TAKEDA PHARMS USA Submission history Latest submission status date: 2023-08-23 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.