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)Rx2026-08-01

Application Products#

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

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
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