Treats cutaneous T-cell lymphoma (CTCL). ANDA 220783, held by Zydus Pharms. Romidepsin.
As of Nov 14, 2026, ANDA 220783 (Romidepsin), held by Zydus Pharms, was first approved by FDA on Oct 19, 2026, 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 19, 2026 | Original application | Approved | None posted |
| 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
