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
12500f21-8e2f-4bcd-861e-4dfca843da2e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 16, 2022
Manufacturers
FDA
BluePoint Laboratories
DUNS: 985523874
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 Code68001-540
Application NumberANDA210824
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bortezomib
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateMay 16, 2022
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Quantity: 35 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
BORTEZOMIBActive
Quantity: 3.5 mg in 1 1
Code: 69G8BD63PP
Classification: ACTIB