FDA Orange Book
Generic for Mitozytrex
Mitozytrex contains mitomycin. 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 Mitozytrex is mitomycin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Mitozytrex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 5MG/VIAL | Discontinued | None | 6 | AP |
NDA 050763, held by SUPERGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic mitomycin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 064144 | AP (A-rated, therapeutically equivalent) | April 30, 1998 | 5MG/VIAL |
| HIKMA PHARMACEUTICALS USA INC | 064180 | AP (A-rated, therapeutically equivalent) | December 23, 1999 | 5MG/VIAL |
| ADAPTIS PHARMA PRIVATE LTD | 202670 | AP (A-rated, therapeutically equivalent) | October 13, 2017 | 5MG/VIAL |
| GLAND PHARMA LTD | 215687 | AP (A-rated, therapeutically equivalent) | October 20, 2021 | 5MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 214505 | AP (A-rated, therapeutically equivalent) | September 8, 2022 | 5MG/VIAL |
| FRESENIUS KABI USA LLC | 211269 | AP (A-rated, therapeutically equivalent) | April 5, 2024 | 5MG/VIAL |
Questions
Is there a generic for Mitozytrex?
Yes. The generic name for Mitozytrex is mitomycin. 6 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 Mitozytrex?
The active ingredient in Mitozytrex is mitomycin, 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.