← FDA Drug Approvals (Drugs@FDA)

JYNARQUE

NDA · New Drug Application · Sponsor: OTSUKA · Approved 2018-04-23

Drug application

FDA Application #

NDA204441

Application type

New Drug Application

Brand name

JYNARQUE

Generic name

TOLVAPTAN

Active ingredients

TOLVAPTAN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

OTSUKA

Manufacturer

Otsuka America Pharmaceutical, Inc.

First approval

2018-04-23

Source

Authoritative

Drugs@FDA application overview

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