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SIMTRIYO

NDA · New Drug Application · Sponsor: OTSUKA PHARMACEUTICAL CO LTD · Approved 2026-07-24

Drug application

FDA Application #

NDA218145

Application type

New Drug Application

Brand name

SIMTRIYO

Generic name

Centanafadine Hydrochloride

Active ingredients

CENTANAFADINE HYDROCHLORIDE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

—

Marketing status

Prescription

Sponsor

OTSUKA PHARMACEUTICAL CO LTD

First approval

2026-07-24

Source

Authoritative

Drugs@FDA application overview

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