Orange Book product · Brand (NDA)
MITOZYTREX
MITOMYCIN
At a glance
Nov 14, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 14, 2002
23 yr 11 mo ago
Today
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5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 050763
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
- —MUTAMYCINBrand (NDA)
NDA 050450 · BRISTOL
- 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.
