FDA.reportPublic FDA data

Application 761086

Type
BLA
Sponsor
AMGEN INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761086Avsolainfliximab-axxq351(k) BiosimilarRx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVSOLAINFLIXIMAB-AXXQINJECTABLE;INJECTION100MG/VIALNoNo

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
AVSOLAINFLIXIMAB-AXXQAmgen, Incde34bcb7-b524-45c8-9181-61c6f48d540e2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761086
ndc (product): 55513-670

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
55513-670AVSOLAinfliximab-axxqAmgen IncBLACurrent
55513-670AVSOLAinfliximab-axxqAmgen IncBLACurrent
55513-670AVSOLAinfliximab-axxqAmgen IncBLACurrent
55513-670AVSOLAinfliximab-axxqAmgen IncBLACurrent
55513-670AVSOLAinfliximab-axxqAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83210SUPPL 2025-08-27
83209SUPPL 2025-08-27
83200SUPPL 2025-08-26
68619SUPPL2021-09-14
68567SUPPL2021-09-10
61737ORIG2020-01-30
61218ORIG2019-12-10
61185ORIG2019-12-06
61172ORIG2019-12-06
63066ORIG1900-01-01