Orange Book product · Generic (ANDA)
MITOMYCIN
MITOMYCIN
At a glance
Nov 29, 1995
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 29, 1995
31 yr ago
Today
Pharmaceutical detail
Active ingredient
MITOMYCIN
Strength
20MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 064106
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MITOMYCIN
- 2025ZUSDURIBrand (NDA)
NDA 215793 · UROGEN PHARMA
- 2020JELMYTOBrand (NDA)
NDA 211728 · UROGEN PHARMA
- 2012MITOSOLBrand (NDA)
NDA 022572 · GLAUKOS
- 2002MITOZYTREXBrand (NDA)
NDA 050763 · SUPERGEN
- —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
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.
