Drug
Who makes romidepsin?
3 companies list romidepsin as a human prescription drug, including under the names ISTODAX. Forms: injection, solution, concentrate; kit. Routes: intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing romidepsin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Fresenius Kabi USA, LLCUnited States | kit | ANDAANDA206254 | 1 | 6 |
| Amneal Ireland LimitedIreland | injection, solution, concentrate | ANDAANDA219099 | 1 | 1 |
| Celgene International Sarl | kit | NDANDA022393 | 1 | 0 |
Bulk ingredient listings
- Concord Biotech LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Sicor S.r.l. · 1 NDC
Enquiry
Common questions
- Who makes romidepsin?
- 3 companies list romidepsin as a human prescription drug in the openFDA NDC Directory, led by Fresenius Kabi USA, LLC, Amneal Ireland Limited, Celgene International Sarl. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic ISTODAX?
- 2 companies list romidepsin under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies romidepsin active ingredient?
- 3 companies list romidepsin as a bulk ingredient, including Concord Biotech Limited, MSN Laboratories Private Limited,, Sicor S.r.l..