Riluzole

ANDA 91300, held by Apotex Corp. Riluzole.

As of Nov 14, 2026, ANDA 91300 (Riluzole), held by Apotex Corp, was first approved by FDA on Jun 18, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 18, 2013
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 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	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Sep 8, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Sep 8, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Jun 18, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 91300
Drugs@FDA: Overview at FDA
Company: Apotex

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