FDA Orange Book
Generic for Mutamycin
Mutamycin 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 Mutamycin 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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Mutamycin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 20MG/VIAL | Discontinued | None | 7 | AP |
| injectable, injection | 5MG/VIAL | Discontinued | None | 6 | AP |
NDA 050450, held by BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO. 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 |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 064117 | AP (A-rated, therapeutically equivalent) | April 19, 1995 | 20MG/VIAL |
| ACCORD HEALTHCARE INC | 064144 | AP (A-rated, therapeutically equivalent) | April 30, 1998 | 20MG/VIAL, 5MG/VIAL |
| HIKMA PHARMACEUTICALS USA INC | 064180 | AP (A-rated, therapeutically equivalent) | December 23, 1999 | 20MG/VIAL, 5MG/VIAL |
| ADAPTIS PHARMA PRIVATE LTD | 202670 | AP (A-rated, therapeutically equivalent) | October 13, 2017 | 20MG/VIAL, 5MG/VIAL |
| GLAND PHARMA LTD | 215687 | AP (A-rated, therapeutically equivalent) | October 20, 2021 | 20MG/VIAL, 5MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 214505 | AP (A-rated, therapeutically equivalent) | September 8, 2022 | 20MG/VIAL, 5MG/VIAL |
| FRESENIUS KABI USA LLC | 211269 | AP (A-rated, therapeutically equivalent) | April 5, 2024 | 20MG/VIAL, 5MG/VIAL |
Questions
Is there a generic for Mutamycin?
Yes. The generic name for Mutamycin 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 Mutamycin?
The active ingredient in Mutamycin 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.