Quick answers
- What is Romidepsin used for?
- The FDA-approved label (Romidepsin, Amneal Pharmaceuticals LLC, September 4, 2025) says: “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. Romidepsin injection is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Romidepsin have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Romidepsin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Romidepsin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Romidepsin?
- 1 company lists prescription products of Romidepsin in the FDA NDC Directory, including Amneal Pharmaceuticals LLC.
What Romidepsin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. Romidepsin injection is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy.
— FDA label: Romidepsin, Amneal Pharmaceuticals LLC, effective September 4, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution, concentrate |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amneal Pharmaceuticals LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA219099Amneal · June 2, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2289413 |
|---|---|
| SPL set ID of the quoted label | 61894b77-f29c-4a81-ad85-bd3a698233a4 |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | ROMIDEPSIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Romidepsin, Amneal Pharmaceuticals LLC, effective September 4, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →