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
aef02171-bf8a-43ad-b40c-7642623f9802
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 9, 2022
Manufacturers
FDA
Qilu Pharmaceutical Co., Ltd.
DUNS: 653878256
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 Code67184-0530
Application NumberANDA210824
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bortezomib
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateMay 9, 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