ANDA 214831, held by Annora Pharma. Brivaracetam.
As of Nov 15, 2026, ANDA 214831 (Brivaracetam), held by Annora Pharma, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 24, 2024 | Original application | Tentative approval | None posted |
| Brivaracetam25mg · tablet; oral | Brivaracetam | None (tentative approval) |
| Brivaracetam50mg · tablet; oral | Brivaracetam | None (tentative approval) |
| Brivaracetam75mg · tablet; oral | Brivaracetam | None (tentative approval) |
| Brivaracetam100mg · tablet; oral | Brivaracetam | None (tentative approval) |
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