FDA.reportPublic FDA data

Application 761140

Type
BLA
Sponsor
AMGEN INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761140Riabnirituximab-arrx351(k) BiosimilarRx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIABNIRITUXIMAB-ARRXINJECTABLE;INJECTION100MG/10ML(10MG/ML)YesNo

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
RiabniRITUXIMAB-ARRXAmgen, Incda1c4de7-0e5b-4f72-97ec-7a8d368f085f2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761140
ndc (product): 55513-326
ndc (product): 55513-224

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-224Riabnirituximab-arrxAmgen IncBLACurrent
55513-224Riabnirituximab-arrxAmgen IncBLACurrent
55513-326Riabnirituximab-arrxAmgen IncBLACurrent
55513-326Riabnirituximab-arrxAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82523SUPPL 2025-06-10
82521SUPPL 2025-06-10
82515SUPPL 2025-06-10
71220SUPPL2022-06-06
71217SUPPL2022-06-06
71216SUPPL2022-06-06
65984ORIG2021-01-26
65646ORIG2020-12-21
65614ORIG2020-12-17
65613ORIG2020-12-17