← FDA DRUG APPROVALS

FDA NDA · NDA204447

TRINTELLIX

vortioxetine

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA204447
TYPE
NDA
ORIGINAL APPROVAL
2013-09-30
LATEST ACTION
2023-08-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

TRINTELLIX · ReferencePrescription
VORTIOXETINE HYDROBROMIDE EQ 10MG BASE · TABLET · ORAL
TRINTELLIX · ReferenceDiscontinued
VORTIOXETINE HYDROBROMIDE EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TRINTELLIX · ReferencePrescription
VORTIOXETINE HYDROBROMIDE EQ 5MG BASE · TABLET · ORAL
TRINTELLIX · ReferencePrescription
VORTIOXETINE HYDROBROMIDE EQ 20MG BASE · TABLET · ORAL

Approval history

2023-08-23Efficacy · Supplement 26 · priority — Letter ↗AP
2023-08-18Labeling · Supplement 27 · standard — Label ↗AP
2021-09-20Labeling · Supplement 24 · standard — Letter ↗AP
2021-01-22Efficacy · Supplement 21 · priority — Letter ↗AP
2021-01-22Labeling · Supplement 22 · standard — Letter ↗AP
2020-11-13Efficacy · Supplement 20 · standard — Letter ↗AP
2019-07-23Labeling · Supplement 18 · standard — Letter ↗AP
2018-10-19Efficacy · Supplement 17 · standard — Label ↗AP
2018-05-02Efficacy · Supplement 6 · standard — Letter ↗AP
2017-04-11Labeling · Supplement 13 · standard — Label ↗AP
2017-04-03Labeling · Supplement 8 · standard — Label ↗AP
2017-03-10Efficacy · Supplement 9 · standard — Label ↗AP
2016-10-17Labeling · Supplement 12 · 901 required — Letter ↗AP
2016-08-30Labeling · Supplement 11 · 901 required — Letter ↗AP
2016-05-02Labeling · Supplement 7 · standard — Letter ↗AP
2015-01-20Manufacturing (CMC) · Supplement 2 · standardAP
2014-09-30Manufacturing (CMC) · Supplement 3 · standardAP
2014-09-08Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2014-07-17Labeling · Supplement 5 · 901 required — Letter ↗AP
2013-12-03Manufacturing (CMC) · Supplement 1 · standardAP
2013-09-30Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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