FDA Orange Book
Generic for Istodax
Istodax contains romidepsin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Istodax is romidepsin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Istodax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 10MG/VIAL | Marketed (Rx) | AP | 1 | AP |
NDA 022393, held by BRISTOL-MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic romidepsin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 206254 | AP (A-rated, therapeutically equivalent) | October 12, 2021 | 10MG/VIAL |
Questions
Is there a generic for Istodax?
Yes. The generic name for Istodax is romidepsin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Istodax?
The active ingredient in Istodax is romidepsin, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.