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FDA Approval

TIVDAK

CompanySeagen Inc. (DUNS: 028484371)

Effective Date

July 27, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Tisotumab vedotin(40 mg in 4 mL)

Products (1)

TIVDAK

NDC Product Code

51144-003

Application Number

BLA761208

Marketing Category

BLA (C73585)

Route of Administration

INTRAVENOUS

Effective Date

January 31, 2022

Ingredients

Tisotumab vedotinActive

Code: T41737F88AClass: ACTIBQuantity: 40 mg in 4 mL

MannitolInactive

Code: 3OWL53L36AClass: IACT

Histidine Monohydrochloride MonohydrateInactive

Code: X573657P6PClass: IACT

SucroseInactive

Code: C151H8M554Class: IACT

HistidineInactive

Code: 4QD397987EClass: IACT

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