Gocovri

NDA 208944, held by Supernus Pharms. Amantadine Hydrochloride.

As of Nov 13, 2026, NDA 208944 (Gocovri), held by Supernus Pharms, was first approved by FDA on Aug 24, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 24, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below


Feb 1, 2021	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 24, 2017	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


GocovriEQ 68.5MG BASE · capsule, extended release;oral	Amantadine Hydrochloride	RxReference drug
GocovriEQ 137MG BASE · capsule, extended release;oral	Amantadine Hydrochloride	RxReference drug

All 4 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 9Labeling · Standard review	Approved	Letter Label
Feb 1, 2021	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 10, 2020	Supplement 3Labeling · Standard review	Approved	Letter Label
Aug 24, 2017	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 208944
Drugs@FDA: Overview at FDA
Company: Supernus Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters