ZYNLONTA
These highlights do not include all the information needed to use ZYNLONTA safely and effectively. See full prescribing information for ZYNLONTA. ZYNLONTA (loncastuximab tesirine-lpyl) for injection, for intravenous use Initial U.S. Approval: 2021
Approved
Approval ID
af54af12-3edf-4301-8bc5-0446bc813c1d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 14, 2023
Manufacturers
FDA
ADC Therapeutics America, Inc.
DUNS: 035224001
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
loncastuximab tesirine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code79952-110
Application NumberBLA761196
Product Classification
M
Marketing Category
C73585
G
Generic Name
loncastuximab tesirine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 19, 2022
FDA Product Classification
INGREDIENTS (5)
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
loncastuximab tesirineActive
Quantity: 10 mg in 2 mL
Code: 7K5O7P6QIU
Classification: ACTIB
polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT