ANDA 216035, held by Alkem Labs Ltd. Riluzole.
As of Nov 14, 2026, ANDA 216035 (Riluzole), held by Alkem Labs Ltd, was first approved by FDA on Aug 22, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Riluzole50MG/10ML ยท suspension;oral | Riluzole | Rx |
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
