Treats amyotrophic lateral sclerosis (ALS). ANDA 91417, held by Sun Pharm Inds Ltd. Riluzole.
As of Nov 14, 2026, ANDA 91417 (Riluzole), held by Sun Pharm Inds Ltd, was first approved by FDA on Jun 18, 2013, with 2 approved supplements and 0 published complete response letters.
Riluzole tablets, USP are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Riluzole50MG · tablet;oral | Riluzole | Discontinued |
| Sep 9, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 9, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jun 18, 2013 | 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
