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SUNOSI

NDA · New Drug Application · Sponsor: AXSOME MALTA · Approved 2019-03-20

Drug application

FDA Application #

NDA211230

Application type

New Drug Application

Brand name

SUNOSI

Generic name

SOLRIAMFETOL

Active ingredients

SOLRIAMFETOL HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

AXSOME MALTA

Manufacturer

Axsome Therapeutics, Inc.

First approval

2019-03-20

Source

Authoritative

Drugs@FDA application overview

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