ANDA 214992, held by Adaptis. Vigabatrin.
As of Nov 15, 2026, ANDA 214992 (Vigabatrin), held by Adaptis, was first approved by FDA on May 13, 2021, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 13, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vigabatrin500MG/PACKET ยท for solution;oral | Vigabatrin | Discontinued |
| Mar 18, 2026 | Supplement 4REMS | Approved | None posted |
| Sep 12, 2024 | Supplement 3REMS | Approved | None posted |
| Oct 12, 2022 | Supplement 2REMS | Approved | None posted |
| May 13, 2021 | Original application | Approved |
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
