Mitomycin
MITOMYCIN FOR INJECTION USP, 5 mg/vial NOVAPLUS
Approved
Approval ID
cef5026c-8bc3-4428-a178-6effff4dcb3f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2023
Manufacturers
FDA
Archis Pharma LLC
DUNS: 026836212
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 Code72819-152
Application NumberANDA202670
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mitomycin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 21, 2023
FDA Product Classification
INGREDIENTS (2)
MITOMYCINActive
Quantity: 5 mg in 10 mL
Code: 50SG953SK6
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT