ANDA 207619, held by Breckenridge. Cabazitaxel.
As of Nov 15, 2026, ANDA 207619 (Cabazitaxel), held by Breckenridge, was first approved by FDA on Jun 23, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cabazitaxel60MG/1.5ML (40MG/ML) ยท solution;intravenous | Cabazitaxel | Discontinued |
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
