NDA 220258, held by Azurity. Cabozantinib.
As of Nov 13, 2026, NDA 220258 (Resniben), held by Azurity, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 24, 2025 | Original application | Tentative approval |
| Resniben13MG · tablet; oral | Cabozantinib | Rx |
| Resniben26MG · tablet; oral | Cabozantinib | Rx |
| Resniben39MG · tablet; oral | Cabozantinib | Rx |
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