Approvals and New Uses
The original application and every efficacy supplement, newest first; all 4 submissions below| Date | Submission | Status | Documents |
|---|
| Aug 29, 2022 | Original application | Approved | REMS |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Vigabatrin500MG · tablet;oral | Vigabatrin | Rx |
All 4 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Mar 18, 2026 | Supplement 4REMS | Approved | None posted |
| Sep 12, 2024 | Supplement 2REMS | Approved | None posted |
| Oct 12, 2022 | Supplement 1REMS | Approved | None posted |
| Aug 29, 2022 | Original application | Approved | REMS |
Identifiers
- Application
- ANDA 213104
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
