BRIUMVI
These highlights do not include all the information needed to use BRIUMVI safely and effectively. See full prescribing information for BRIUMVI. BRIUMVI™ (ublituximab-xiiy) injection, for intravenous use Initial U.S. Approval: 2022
Approved
Approval ID
3a77cd8c-811b-407c-9140-d0c5c26435c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2023
Manufacturers
FDA
TG Therapeutics, Inc.
DUNS: 117372682
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ublituximab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73150-150
Application NumberBLA761238
Product Classification
M
Marketing Category
C73585
G
Generic Name
ublituximab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 19, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
UBLITUXIMABActive
Quantity: 150 mg in 6 mL
Code: U59UGK3IPC
Classification: ACTIB