FDA.reportPublic FDA data

Application 103764

Type
BLA
Sponsor
NOVARTIS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103764Simulectbasiliximab351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIMULECTBASILIXIMABVIAL; SINGLE-USE10MGNoNo
002SIMULECTBASILIXIMABVIAL; SINGLE-USE20MGNoNo

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimulectBASILIXIMABNovartis Pharmaceuticals Corporation1af01887-b69d-444b-91ed-ebfe127844402025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103764
ndc (product): 0078-0331
ndc (product): 0078-0393

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
0078-0331SimulectbasiliximabNovartis Pharmaceuticals CorporationBLACurrent
0078-0331SimulectbasiliximabNovartis Pharmaceuticals CorporationBLACurrent
0078-0331SimulectbasiliximabNovartis Pharmaceuticals CorporationBLACurrent
0078-0331SimulectbasiliximabNovartis Pharmaceuticals CorporationBLACurrent
0078-0331SimulectbasiliximabNovartis Pharmaceuticals CorporationBLACurrent
0078-0331SimulectbasiliximabNovartis Pharmaceuticals CorporationBLACurrent
0078-0393SimulectbasiliximabNovartis Pharmaceuticals CorporationBLACurrent
0078-0393SimulectbasiliximabNovartis Pharmaceuticals CorporationBLACurrent
0078-0393SimulectbasiliximabNovartis Pharmaceuticals CorporationBLACurrent
0078-0393SimulectbasiliximabNovartis Pharmaceuticals CorporationBLACurrent
0078-0393SimulectbasiliximabNovartis Pharmaceuticals CorporationBLACurrent
0078-0393SimulectbasiliximabNovartis Pharmaceuticals CorporationBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43278ORIG2004-03-29
39685SUPPL2004-03-29
39684SUPPL2004-03-29
31629ORIG2004-03-29
18623ORIG2004-03-29
9429SUPPL2004-03-29
9428SUPPL2004-03-29
31630SUPPL2003-12-04