Application 761306

Type
BLA
Sponsor
ELI LILLY AND CO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761306Ebglysslebrikizumab-lbkz351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EBGLYSSLEBRIKIZUMAB-LBKZINJECTABLE;INJECTION250MG/2MLNoNo

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EBGLYSSLEBRIKIZUMAB-LBKZEli Lilly and Company7a774ea2-acde-4aaa-9a8f-ccba5a5b1d5f2026-06-09Warnings, Adverse reactionsExact identifier
application number: BLA761306

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83990SUPPL 2025-10-29
83965SUPPL 2025-10-29
82449SUPPL 2025-06-03
82318SUPPL 2025-05-27
79902ORIG 2024-10-15
79634ORIG 2024-09-16
79602ORIG 2024-09-16