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TRINTELLIX

NDA · New Drug Application · Sponsor: TAKEDA PHARMS USA · Approved 2013-09-30

Drug application

FDA Application #

NDA204447

Application type

New Drug Application

Brand name

TRINTELLIX

Generic name

VORTIOXETINE

Active ingredients

VORTIOXETINE HYDROBROMIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

TAKEDA PHARMS USA

Manufacturer

Takeda Pharmaceuticals America, Inc.

First approval

2013-09-30

Source

Authoritative

Drugs@FDA application overview

Machine

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