FDA.reportPublic FDA data

Application 125516

Type
BLA
Sponsor
UNITED THERAP

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125516Unituxindinutuximab351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UNITUXINDINUTUXIMABINJECTABLE;INTRAVENOUS17.5MG/5MLNoNo

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
UnituxinDINUTUXIMABUnited Therapeutics Corporationd66bdf0d-9d65-45de-ae5b-a58617c274922026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125516
ndc (product): 66302-014

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66302-014UnituxinDINUTUXIMABUnited Therapeutics Corp.BLACurrent
66302-014UnituxinDINUTUXIMABUnited Therapeutics Corp.BLACurrent
66302-014UnituxinDINUTUXIMABUnited Therapeutics Corp.BLACurrent
66302-014UnituxinDINUTUXIMABUnited Therapeutics CorporationBLACurrent
66302-014UnituxinDINUTUXIMABUnited Therapeutics CorporationBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83753SUPPL 2025-10-15
83746SUPPL 2025-10-10
64775SUPPL2020-10-01
64762SUPPL2020-09-30
47464SUPPL2017-03-03
47388SUPPL2017-03-02
44815ORIG2015-04-09
43335ORIG2015-04-09
39985ORIG2015-03-10
9775ORIG2015-03-10