FDA.reportPublic FDA data

Application 761151

Type
BLA
Sponsor
UCB INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761151Bimzelxbimekizumab-bkzx351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BIMZELXBIMEKIZUMAB-BKZXINJECTABLE;INJECTION160MLNoNo

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
BimzelxBIMEKIZUMABUCB, Inc.26b88358-871f-4c80-9d80-b2fb16477f812025-06-16Warnings, Adverse reactionsExact identifier
application number: BLA761151

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80259SUPPL 2024-11-21
80250SUPPL 2024-11-20
79906SUPPL 2024-10-15
79881SUPPL 2024-10-14
79880SUPPL 2024-10-14
79725SUPPL 2024-09-24
79724SUPPL 2024-09-24
79723SUPPL 2024-09-24
79684SUPPL 2024-09-23
79683SUPPL 2024-09-23
79682SUPPL 2024-09-23
76705ORIG 2023-12-01
75852ORIG 2023-10-19
75849ORIG 2023-10-19