FDA Orange Book
Generic for Blenoxane
Blenoxane contains bleomycin. 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 Blenoxane is bleomycin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Blenoxane products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 15 UNITS BASE/VIAL | Discontinued | None | 4 | AP |
| injectable, injection | EQ 30 UNITS BASE/VIAL | Discontinued | None | 4 | AP |
NDA 050443, held by BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bleomycin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HOSPIRA INC | 065031 | AP (A-rated, therapeutically equivalent) | March 10, 2000 | EQ 15 UNITS BASE/VIAL, EQ 30 UNITS BASE/VIAL |
| HIKMA PHARMACEUTICALS USA INC | 065042 | AP (A-rated, therapeutically equivalent) | October 17, 2001 | EQ 15 UNITS BASE/VIAL, EQ 30 UNITS BASE/VIAL |
| FRESENIUS KABI USA LLC | 065185 | AP (A-rated, therapeutically equivalent) | January 28, 2008 | EQ 15 UNITS BASE/VIAL, EQ 30 UNITS BASE/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 205030 | AP (A-rated, therapeutically equivalent) | April 20, 2018 | EQ 15 UNITS BASE/VIAL, EQ 30 UNITS BASE/VIAL |
Questions
Is there a generic for Blenoxane?
Yes. The generic name for Blenoxane is bleomycin. 4 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 Blenoxane?
The active ingredient in Blenoxane is bleomycin, 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.