Blenrep

Blenrep

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 167380711

Effective Date

February 28, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

0173-0896

Application Number

BLA761158

Marketing Category

BLA (C73585)

Route of Administration

INTRAVENOUS

Effective Date

February 28, 2022

Ingredients

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

Code: DB1041CXDGClass: ACTIBQuantity: 50 mg in 1 mL

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

TREHALOSE DIHYDRATEInactive

Code: 7YIN7J07X4Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT