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FDA NDA · NDA208944

GOCOVRI

amantadine

Sponsor: SUPERNUS PHARMS

APPLICATION
NDA208944
TYPE
NDA
ORIGINAL APPROVAL
2017-08-24
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

GOCOVRI · ReferencePrescription
AMANTADINE HYDROCHLORIDE EQ 137MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
GOCOVRI · ReferencePrescription
AMANTADINE HYDROCHLORIDE EQ 68.5MG BASE · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-07-10Labeling · Supplement 9 · standard — Letter ↗AP
2021-02-01Efficacy · Supplement 4 · standard — Label ↗AP
2020-03-10Labeling · Supplement 3 · standard — Letter ↗AP
2017-08-24Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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