Home Applications 761196 Application 761196
Type BLA
Sponsor ADC Therapeutics SA Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761196 Zynlonta loncastuximab tesirine-lpyl 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZYNLONTA LONCASTUXIMAB TESIRINE-LPYL INJECTABLE;INJECTION 10MG No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZYNLONTA LONCASTUXIMAB TESIRINE ADC Therapeutics America, Inc. af54af12-3edf-4301-8bc5-0446bc813c1d 2026-06-12 Warnings, Adverse reactions Exact identifier application number: BLA761196 ndc (product): 79952-110
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 79952-110 ZYNLONTA loncastuximab tesirine ADC Therapeutics America, Inc. BLA Current 79952-110 ZYNLONTA loncastuximab tesirine ADC Therapeutics America, Inc. BLA Current 79952-110 ZYNLONTA loncastuximab tesirine ADC Therapeutics America, Inc. BLA Current 79952-110 ZYNLONTA loncastuximab tesirine ADC Therapeutics America, Inc. BLA Current 79952-110 ZYNLONTA loncastuximab tesirine ADC Therapeutics America, Inc. BLA Current 79952-110 ZYNLONTA loncastuximab tesirine ADC Therapeutics America, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 85144 SUPPL 2026-02-24 85115 SUPPL 2026-02-24 84814 SUPPL 2026-01-22 84802 SUPPL 2026-01-21 72398 SUPPL 2022-10-17 72397 SUPPL 2022-10-17 72317 SUPPL 2022-10-13 72316 SUPPL 2022-10-13 67576 ORIG 2021-05-24 67180 ORIG 2021-04-27 67161 ORIG 2021-04-23