Riluzole

ANDA 76173, held by Impax Labs. Riluzole.

As of Nov 14, 2026, ANDA 76173 (Riluzole), held by Impax Labs, was first approved by FDA on Jan 29, 2003, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 29, 2003
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Jan 29, 2003	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 11Labeling · Standard review	Approved	None posted
Sep 27, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Sep 27, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Jan 29, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 76173
Drugs@FDA: Overview at FDA
Company: Impax Laboratories

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