Orange Book product · Brand (NDA)
MUTAMYCIN
MITOMYCIN
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
MITOMYCIN
Strength
5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050450
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025ZUSDURIBrand (NDA)
NDA 215793 · UROGEN PHARMA
- 2020JELMYTOBrand (NDA)
NDA 211728 · UROGEN PHARMA
- 2012MITOSOLBrand (NDA)
NDA 022572 · GLAUKOS
- 2002MITOZYTREXBrand (NDA)
NDA 050763 · SUPERGEN
- 2024MITOMYCINGeneric (ANDA)
ANDA 211269 · FRESENIUS KABI USA
- 2023MITOMYCINGeneric (ANDA)
ANDA 216732 · EUGIA PHARMA
- 2022MITOMYCINGeneric (ANDA)
ANDA 216648 · GLAND
- 2022MITOMYCINGeneric (ANDA)
ANDA 214505 · MEITHEAL
- 2022MITOMYCINGeneric (ANDA)
ANDA 214504 · MEITHEAL
- 2021MITOMYCINGeneric (ANDA)
ANDA 215687 · GLAND
- 2017MITOMYCINGeneric (ANDA)
ANDA 202670 · RK PHARMA
- 2017MITOMYCINGeneric (ANDA)
ANDA 203386 · RK PHARMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
