Orange Book product · Generic (ANDA)
MITOMYCIN
MITOMYCIN
At a glance
Oct 13, 2017
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 13, 2017
8 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
MITOMYCIN
Strength
40MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 203386
Product number
001
Marketing status
RX
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.
