FDA.reportPublic FDA data

Application 761279

Type
BLA
Sponsor
ELI LILLY AND CO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761279Omvohmirikizumab-mrkz351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMVOHMIRIKIZUMAB-MRKZVIAL; SINGLE-USE300MG/15MLNoNo
002OMVOHMIRIKIZUMAB-MRKZINJECTABLE;SUBCUTANEOUS100MG/MLNoNo

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmvohMIRIKIZUMAB-MRKZEli Lilly and Company472cbe04-263e-433d-9a0f-58c1b50b715a2025-11-04Warnings, Adverse reactionsExact identifier
application number: BLA761279

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83917SUPPL 2025-10-27
83916SUPPL 2025-10-27
83914SUPPL 2025-10-24
83913SUPPL 2025-10-24
80880SUPPL 2025-01-21
80879SUPPL 2025-01-21
80857SUPPL 2025-01-16
80856SUPPL 2025-01-16
78318SUPPL 2024-04-30
78311SUPPL 2024-04-30
76666ORIG 2023-11-27
75976ORIG 2023-10-27
75964ORIG 2023-10-27