NDA 208715, held by Sandoz. Cabazitaxel.
As of Nov 13, 2026, NDA 208715 (Cabazitaxel), held by Sandoz, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2023 | Original applicationNew dosage form · Standard review | Tentative approval |
| Cabazitaxel45MG/4.5ML (10MG/ML) · solution;intravenous | Cabazitaxel | None (tentative approval)Reference drug |
| Cabazitaxel60MG/6ML (10MG/ML) · solution;intravenous | Cabazitaxel | None (tentative approval)Reference drug |
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