Riluzole

Treats amyotrophic lateral sclerosis (ALS). ANDA 91394, held by Glenmark Pharms Ltd. Riluzole.

As of Nov 14, 2026, ANDA 91394 (Riluzole), held by Glenmark Pharms Ltd, was first approved by FDA on Jun 18, 2013, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 18, 2013
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Jun 18, 2013	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Riluzole50MG · tablet;oral	Riluzole	Rx

All 4 submissions, including labeling and manufacturing supplements


Aug 11, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Aug 2, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Aug 2, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Jun 18, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 91394
Drugs@FDA: Overview at FDA
Company: Glenmark 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