ANDA 209877, held by Accord Hlthcare. Perampanel.
As of Nov 14, 2026, ANDA 209877 (Perampanel), held by Accord Hlthcare, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 8, 2021 | Original application | Tentative approval | None posted |
| Perampanel2MG · tablet;oral | Perampanel | None (tentative approval) |
| Perampanel4MG · tablet;oral | Perampanel | None (tentative approval) |
| Perampanel6MG · tablet;oral | Perampanel | None (tentative approval) |
| Perampanel8MG · tablet;oral | Perampanel | None (tentative approval) |
| Perampanel10MG · tablet;oral | Perampanel | None (tentative approval) |
| Perampanel12MG · tablet;oral | Perampanel | 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