FDA Orange Book
Generic for Busulfex
Busulfex contains busulfan. 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 Busulfex is busulfan. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Busulfex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 6MG/ML | Marketed (Rx) | AP | 7 | AP |
NDA 020954, held by OTSUKA PHARMACEUTICAL CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic busulfan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PHARMASCIENCE INC | 207050 | AP (A-rated, therapeutically equivalent) | March 24, 2017 | 6MG/ML |
| AMNEAL EU LTD | 209580 | AP (A-rated, therapeutically equivalent) | December 18, 2017 | 6MG/ML |
| HOSPIRA INC | 205672 | AP (A-rated, therapeutically equivalent) | July 31, 2018 | 6MG/ML |
| ACCORD HEALTHCARE INC USA | 210148 | AP (A-rated, therapeutically equivalent) | February 22, 2019 | 6MG/ML |
| ADAPTIS PHARMA PRIVATE LTD | 210931 | AP (A-rated, therapeutically equivalent) | April 18, 2019 | 6MG/ML |
| MEITHEAL PHARMACEUTICALS INC | 212127 | AP (A-rated, therapeutically equivalent) | October 23, 2020 | 6MG/ML |
| PRINSTON PHARMACEUTICAL INC | 215235 | AP (A-rated, therapeutically equivalent) | September 11, 2024 | 6MG/ML |
Questions
Is there a generic for Busulfex?
Yes. The generic name for Busulfex is busulfan. 7 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 Busulfex?
The active ingredient in Busulfex is busulfan, 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.