MITOMYCIN
Mitomycin for Injection, USP
Approved
Approval ID
9dd0e3f2-0938-4c57-8d09-040b5405b44f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2022
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MITOMYCIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-137
Application NumberANDA214505
Product Classification
M
Marketing Category
C73584
G
Generic Name
MITOMYCIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 8, 2022
FDA Product Classification
INGREDIENTS (2)
MITOMYCINActive
Quantity: 5 mg in 10 mL
Code: 50SG953SK6
Classification: ACTIB
mannitolInactive
Quantity: 10 mg in 10 mL
Code: 3OWL53L36A
Classification: IACT
MITOMYCIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-138
Application NumberANDA214505
Product Classification
M
Marketing Category
C73584
G
Generic Name
MITOMYCIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 8, 2022
FDA Product Classification
INGREDIENTS (2)
MITOMYCINActive
Quantity: 20 mg in 40 mL
Code: 50SG953SK6
Classification: ACTIB
mannitolInactive
Quantity: 40 mg in 40 mL
Code: 3OWL53L36A
Classification: IACT