Home Applications 761375 Application 761375
Type BLA
Sponsor EISAI INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761375 Leqembi IQLIK lecanemab-irmb 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 003 LEQEMBI IQLIK LECANEMAB-IRMB INJECTABLE;SUBCUTANEOUS 360MG/1.8ML(200MG/ML) 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 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LEQEMBI LECANEMAB Eisai Inc. 9d1ff786-e577-410a-a273-c4d7d0e4e975 2026-07-21 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761375
Documents# Document, Submission type, Date table Document Submission type Date 83271 ORIG 2025-09-03 83254 ORIG 2025-09-02 83253 ORIG 2025-09-02