Treats cutaneous T-cell lymphoma (CTCL). ANDA 206254, held by Fresenius Kabi USA. Romidepsin.
As of Nov 14, 2026, ANDA 206254 (Romidepsin), held by Fresenius Kabi USA, was first approved by FDA on Oct 12, 2021, with 0 approved supplements and 0 published complete response letters.
Romidepsin for injection is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 12, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Romidepsin10MG/VIAL · powder;intravenous | Romidepsin | 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
