BORTEZOMIB
These highlights do not include all the information needed to use BORTEZOMIB FOR INJECTION safely and effectively. See full prescribing information for BORTEZOMIB FOR INJECTION. BORTEZOMIB for injection, for subcutaneous or intravenous use Initial U.S. Approval: 2003
Approved
Approval ID
76c7c3a5-fd2f-403f-85fd-65a64538eee7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 29, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BORTEZOMIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55150-337
Application NumberANDA212825
Product Classification
M
Marketing Category
C73584
G
Generic Name
BORTEZOMIB
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJuly 29, 2023
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
BORTEZOMIBActive
Quantity: 3.5 mg in 1 1
Code: 69G8BD63PP
Classification: ACTIB