MITOMYCIN
Mitomycin for Injection, 40 mg/vial Rx only
Approved
Approval ID
bc937e3d-7167-49a5-b6b1-004b0f89d8c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
Products 1
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 Code65219-568
Application NumberANDA216648
Product Classification
M
Marketing Category
C73584
G
Generic Name
MITOMYCIN
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 23, 2022
FDA Product Classification
INGREDIENTS (2)
MITOMYCINActive
Quantity: 40 mg in 80 mL
Code: 50SG953SK6
Classification: ACTIB
MANNITOLInactive
Quantity: 80 mg in 80 mL
Code: 3OWL53L36A
Classification: IACT