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GOCOVRI

NDA · New Drug Application · Sponsor: SUPERNUS PHARMS · Approved 2017-08-24

Drug application

FDA Application #

NDA208944

Application type

New Drug Application

Brand name

GOCOVRI

Generic name

AMANTADINE

Active ingredients

AMANTADINE HYDROCHLORIDE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

SUPERNUS PHARMS

Manufacturer

Adamas Pharma, LLC

First approval

2017-08-24

Source

Authoritative

Drugs@FDA application overview

Machine

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