ANDA 220470, held by Breckenridge. Brivaracetam.
As of Nov 15, 2026, ANDA 220470 (Brivaracetam), held by Breckenridge, was first approved by FDA on Feb 23, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2026 | Original application | Approved | None posted |
| Brivaracetam10MG · tablet;oral | Brivaracetam | Discontinued |
| Brivaracetam25MG · tablet;oral | Brivaracetam | Discontinued |
| Brivaracetam50MG · tablet;oral | Brivaracetam | Discontinued |
| Brivaracetam75MG · tablet;oral | Brivaracetam | Discontinued |
| Brivaracetam100MG · tablet;oral | Brivaracetam | 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
