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FDA Approval

ZYNLONTA

CompanyADC Therapeutics America, Inc. (DUNS: 035224001)

Effective Date

July 14, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Loncastuximab tesirine(10 mg in 2 mL)

Products (1)

ZYNLONTA

NDC Product Code

79952-110

Application Number

BLA761196

Marketing Category

BLA (C73585)

Route of Administration

INTRAVENOUS

Effective Date

October 19, 2022

Ingredients

HISTIDINEInactive

Code: 4QD397987EClass: IACT

Loncastuximab tesirineActive

Code: 7K5O7P6QIUClass: ACTIBQuantity: 10 mg in 2 mL

polysorbate 20Inactive

Code: 7T1F30V5YHClass: IACT

HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive

Code: X573657P6PClass: IACT

sucroseInactive

Code: C151H8M554Class: IACT

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