ANDA 219583, held by Shandong New Time Pharmaceutical Co Ltd. Brivaracetam.
As of Nov 15, 2026, ANDA 219583 (Brivaracetam), held by Shandong New Time Pharmaceutical Co Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 2026 | Original application | Tentative approval | None posted |
| Brivaracetam10MG · tablet | Brivaracetam | None (tentative approval) |
| Brivaracetam25MG · tablet | Brivaracetam | None (tentative approval) |
| Brivaracetam50MG · tablet | Brivaracetam | None (tentative approval) |
| Brivaracetam75MG · tablet | Brivaracetam | None (tentative approval) |
| Brivaracetam100MG · tablet | 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
