Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Samsung Biologics Co., Ltd.
TG Therapeutics, Inc.
557810567
Packaging Coordinators, LLC
TG Therapeutics, Inc.
078525133
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BRIUMVI
Product Details
NDC Product Code
73150-150Application Number
BLA761238Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
January 19, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
UblituximabActive
Code: U59UGK3IPCClass: ACTIBQuantity: 150 mg in 6 mL