FDA.reportPublic FDA data

Application 125496

Type
BLA
Sponsor
JANSSEN BIOTECH

Application Products#

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

NDC Listings For This Application#

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