ANDA 219403, held by Zenara Pharma Private Ltd. Cenobamate.
As of Nov 15, 2026, ANDA 219403 (Cenobamate), held by Zenara Pharma Private Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 2, 2025 | Original application | Tentative approval | None posted |
| Cenobamate50MG · tablet | Cenobamate | None (tentative approval) |
| Cenobamate200MG · tablet | Cenobamate | None (tentative approval) |
| Cenobamate100MG · tablet | Cenobamate | None (tentative approval) |
| Cenobamate25MG · tablet | Cenobamate | None (tentative approval) |
| Cenobamate12.5MG · tablet | Cenobamate | 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
