FDA.reportPublic FDA data

Application 125496

Type
BLA
Sponsor
JANSSEN BIOTECH

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125496Sylvantsiltuximab351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYLVANTSILTUXIMABINJECTABLE;INJECTION100MGNoNo
002SYLVANTSILTUXIMABINJECTABLE;INJECTION400MGNoNo

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
SylvantSILTUXIMABRecordati Rare Diseases, Inc.8d663642-f52e-49c0-a023-2da083fdfc0b2024-08-27Warnings, Adverse reactionsExact identifier
application number: BLA125496
ndc (product): 73090-420
ndc (product): 73090-421

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57894-420SYLVANTsiltuximabJanssen Biotech, Inc.BLACurrent
57894-420SYLVANTsiltuximabJanssen Biotech, Inc.BLACurrent
57894-421SYLVANTsiltuximabJanssen Biotech, Inc.BLACurrent
57894-421SYLVANTsiltuximabJanssen Biotech, Inc.BLACurrent
73090-420SylvantSiltuximabEUSA Pharma (UK) LtdBLACurrent
73090-420SylvantSiltuximabEUSA Pharma (UK) LtdBLACurrent
73090-420SylvantSiltuximabEUSA Pharma (UK) LtdBLACurrent
73090-420SylvantSiltuximabEUSA Pharma (UK) LtdBLACurrent
73090-421SylvantSiltuximabEUSA Pharma (UK) LtdBLACurrent
73090-421SylvantSiltuximabEUSA Pharma (UK) LtdBLACurrent
73090-421SylvantSiltuximabEUSA Pharma (UK) LtdBLACurrent
73090-421SylvantSiltuximabEUSA Pharma (UK) LtdBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61512SUPPL2020-02-10
61173SUPPL2020-02-10
54406SUPPL2018-06-01
54398SUPPL2018-05-31
43332ORIG2015-09-28
44810ORIG2014-05-27
31979ORIG2014-04-24
18923ORIG2014-04-23