ANDA 207381, held by Mylan Labs Ltd. Cabazitaxel.
As of Nov 15, 2026, ANDA 207381 (Cabazitaxel), held by Mylan Labs Ltd, was first approved by FDA on Jul 5, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 5, 2023 | 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
