Riluzole

ANDA 203042, held by Pharmobedient. Riluzole.

As of Nov 14, 2026, ANDA 203042 (Riluzole), held by Pharmobedient, was first approved by FDA on Jul 1, 2013, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 1, 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
Jul 1, 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 3Labeling · Standard review	Approved	None posted
Jul 1, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 203042
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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