Treats cutaneous T-cell lymphoma (CTCL). ANDA 219099, held by Amneal. Romidepsin.
As of Nov 14, 2026, ANDA 219099 (Romidepsin), held by Amneal, was first approved by FDA on Jun 2, 2026, with 0 approved supplements and 0 published complete response letters.
Romidepsin 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 |
|---|---|---|---|
| Jun 2, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Romidepsin27.5MG/5.5ML (5MG/ML) · solution;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
