ANDA 207718, held by Dr Reddys. Cabazitaxel.
As of Nov 15, 2026, ANDA 207718 (Cabazitaxel), held by Dr Reddys, was first approved by FDA on Feb 10, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cabazitaxel60MG/1.5ML (40MG/ML) ยท solution;intravenous | Cabazitaxel | 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
