FDA.reportPublic FDA data

Application 761180

Type
BLA
Sponsor
LEO PHARMA AS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761180Adbrytralokinumab-ldrm351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADBRYTRALOKINUMABINJECTABLE;INJECTION150MG/MLNoNo

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
AdbryTRALOKINUMAB-LDRMLEO Pharma Inc.d8020b69-3001-44e2-9b5d-5f93d9aaf6e12025-12-17Warnings, Adverse reactionsExact identifier
application number: BLA761180
ndc (product): 50222-346

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50222-346Adbrytralokinumab-ldrmLEO Pharma Inc.BLACurrent
50222-346Adbrytralokinumab-ldrmLEO Pharma Inc.BLACurrent
50222-346Adbrytralokinumab-ldrmLEO Pharma Inc.BLACurrent
50222-346Adbrytralokinumab-ldrmLEO Pharma Inc.BLACurrent
50222-346Adbrytralokinumab-ldrmLEO Pharma Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84450SUPPL 2025-12-18
84419SUPPL 2025-12-15
78784SUPPL 2024-06-13
78781SUPPL 2024-06-13
76859SUPPL 2023-12-15
76848SUPPL 2023-12-15
74429SUPPL 2023-06-05
71653SUPPL2022-07-28
69964ORIG2022-01-25
69793ORIG2021-12-28
69791ORIG2021-12-28