Treats amyotrophic lateral sclerosis (ALS). ANDA 204048, held by Alkem Labs Ltd. Riluzole.
As of Nov 14, 2026, ANDA 204048 (Riluzole), held by Alkem Labs Ltd, was first approved by FDA on Mar 30, 2016, with 2 approved supplements and 0 published complete response letters.
Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Riluzole50MG · tablet;oral | Riluzole | Rx |
| Aug 13, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 13, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 30, 2016 | Original application | Approved | None posted |
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
