MUTAMYCIN
MUTAMYCIN (Mitomycin) FOR INJECTION USP, 5 mg/vial, 20 mg/vial and 40 mg/vial
Approved
Approval ID
cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2017
Manufacturers
FDA
Accord BioPharma Inc.
DUNS: 079636487
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 Code69448-002
Application NumberANDA064144
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mitomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 1, 2017
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Quantity: 40 mg in 40 mL
Code: 3OWL53L36A
Classification: IACT
MITOMYCINActive
Quantity: 20 mg in 40 mL
Code: 50SG953SK6
Classification: ACTIB
Mitomycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69448-001
Application NumberANDA064144
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mitomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 1, 2017
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Quantity: 10 mg in 10 mL
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 Code69448-003
Application NumberANDA064144
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mitomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 1, 2017
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Quantity: 80 mg in 80 mL
Code: 3OWL53L36A
Classification: IACT
MITOMYCINActive
Quantity: 40 mg in 80 mL
Code: 50SG953SK6
Classification: ACTIB