FDA.reportPublic FDA data

Application 761286

Type
BLA
Sponsor
UCB INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761286Rystiggorozanolixizumab-noli351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RYSTIGGOROZANOLIXIZUMAB-NOLIINJECTABLE;SUBCUTANEOUS280MG/2ML(140MG/ML)NoNo

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
RYSTIGGOROZANOLIXIZUMABUCB, Inc.3c0eb8c2-c042-4954-b451-3baa77f5e6d12026-01-20Warnings, Adverse reactionsExact identifier
application number: BLA761286

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84439SUPPL 2025-12-18
84376SUPPL 2025-12-10
80205SUPPL 2024-11-13
74881ORIG 2023-07-25
74641ORIG 2023-06-27
74635ORIG 2023-06-27