ANDA 204430, held by Daito Pharms Co Ltd. Riluzole.
As of Nov 14, 2026, ANDA 204430 (Riluzole), held by Daito Pharms Co Ltd, was first approved by FDA on Oct 16, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Riluzole50MG ยท tablet;oral | Riluzole | Discontinued |
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
