FDA Orange Book
Generic for Fludara
Fludara contains fludarabine. 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 Fludara is fludarabine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Fludara products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 50MG/VIAL | Discontinued | None | 3 | AP |
NDA 020038, held by GENZYME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fludarabine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 076349 | AP (A-rated, therapeutically equivalent) | August 28, 2003 | 50MG/VIAL |
| FRESENIUS KABI USA LLC | 078544 | AP (A-rated, therapeutically equivalent) | October 15, 2007 | 50MG/VIAL |
| ACTAVIS TOTOWA LLC | 078610 | AP (A-rated, therapeutically equivalent) | February 11, 2009 | 50MG/VIAL |
Questions
Is there a generic for Fludara?
Yes. The generic name for Fludara is fludarabine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Fludara?
The active ingredient in Fludara is fludarabine, 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.