FDA.reportPublic FDA data

Application 761154

Type
BLA
Sponsor
MYLAN PHARMS INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761154Hulioadalimumab-fkjp351(k) InterchangeableRx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HULIOADALIMUMAB-FKJPINJECTABLE;INJECTION20MG;0.4MLNoNo

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 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdalimumabADALIMUMAB-FKJPBiocon Biologics Inc5cde907d-6747-0e62-db25-1718ee717fe72026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761154
HULIOADALIMUMAB-FKJPBiocon Biologics Inc661ad70b-c313-2899-8a7e-7a67bd897ca92025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761154

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81119SUPPL 2025-02-07
81118SUPPL 2025-02-07
77117SUPPL 2023-12-22
77043SUPPL 2023-12-19
75308SUPPL 2023-08-29
75303SUPPL 2023-08-28
73934SUPPL 2023-04-03
73927SUPPL 2023-04-03
71568SUPPL2022-07-15
71561SUPPL2022-07-15
64790ORIG2020-10-02
63812ORIG2020-07-07
63811ORIG2020-07-07
63808ORIG2020-07-07