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
c9bf8425-afa5-4171-b114-d83acb6d526d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2023
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
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 Code50742-484
Application NumberANDA210824
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bortezomib
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateApril 11, 2022
FDA Product Classification
INGREDIENTS (2)
bortezomibActive
Quantity: 3.5 mg in 1 1
Code: 69G8BD63PP
Classification: ACTIB
mannitolInactive
Quantity: 35 mg in 1 1
Code: 3OWL53L36A
Classification: IACT