MITOMYCIN
Mitomycin for Injection, USP Rx only
Approved
Approval ID
f5a010cf-5954-4e6d-acfa-fb414efdf471
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 3
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 Code55150-452
Application NumberANDA216732
Product Classification
M
Marketing Category
C73584
G
Generic Name
MITOMYCIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 12, 2023
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MITOMYCINActive
Quantity: 40 mg in 80 mL
Code: 50SG953SK6
Classification: ACTIB
MITOMYCIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-450
Application NumberANDA216732
Product Classification
M
Marketing Category
C73584
G
Generic Name
MITOMYCIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 12, 2023
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MITOMYCINActive
Quantity: 5 mg in 10 mL
Code: 50SG953SK6
Classification: ACTIB
MITOMYCIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-451
Application NumberANDA216732
Product Classification
M
Marketing Category
C73584
G
Generic Name
MITOMYCIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 12, 2023
FDA Product Classification
INGREDIENTS (2)
MITOMYCINActive
Quantity: 20 mg in 40 mL
Code: 50SG953SK6
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT