Blenrep
These highlights do not include all the information needed to use BLENREP safely and effectively. See full prescribing information for BLENREP.BLENREP (belantamab mafodotin-blmf) for injection, for intravenous useInitial U.S. Approval: 2020
Approved
Approval ID
16a160a4-3ec0-4ddf-99ce-05912dd3382d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2022
Manufacturers
FDA
GlaxoSmithKline LLC
DUNS: 167380711
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Belantamab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0896
Application NumberBLA761158
Product Classification
M
Marketing Category
C73585
G
Generic Name
Belantamab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 28, 2022
FDA Product Classification
INGREDIENTS (6)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
BELANTAMAB MAFODOTINActive
Quantity: 50 mg in 1 mL
Code: DB1041CXDG
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT