FDA.reportPublic FDA data

Application 761269

Type
BLA
Sponsor
EISAI INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761269Leqembilecanemab-irmb351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEQEMBILECANEMAB-IRMBINJECTABLE;INJECTION500MG/5MLYesNo
002LEQEMBILECANEMAB-IRMBINJECTABLE;INJECTION200MG/2MLYesNo

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEQEMBILECANEMABEisai Inc.9d1ff786-e577-410a-a273-c4d7d0e4e9752026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761269
ndc (product): 62856-212
ndc (product): 62856-215

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62856-212LEQEMBIlecanemabEisai Inc.BLACurrent
62856-215LEQEMBIlecanemabEisai Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84812SUPPL 2026-01-22
84801SUPPL 2026-01-21
84800SUPPL 2026-01-21
84498SUPPL 2025-12-22
84497SUPPL 2025-12-22
84458SUPPL 2025-12-18
84457SUPPL 2025-12-18
83187SUPPL 2025-08-25
83171SUPPL 2025-08-22
81107SUPPL 2025-02-06
80982SUPPL 2025-02-05
80222SUPPL 2024-11-15
80219SUPPL 2024-11-15
78096SUPPL 2024-04-09
74712SUPPL 2023-09-05
74690SUPPL 2023-09-05
73385ORIG 2023-02-06
73117ORIG2023-01-09
73116ORIG2023-01-06
73115ORIG2023-01-06
73114ORIG2023-01-06