ANDA 207736, held by Apotex. Cabazitaxel.
As of Nov 15, 2026, ANDA 207736 (Cabazitaxel), held by Apotex, was first approved by FDA on Feb 10, 2023, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cabazitaxel60MG/1.5ML (40MG/ML) · solution;intravenous | Cabazitaxel | Discontinued |
| Apr 4, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 10, 2023 | Original application | Approved |
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
