FDA.reportPublic FDA data

Application 125516

Type
BLA
Sponsor
UNITED THERAP

Application Products#

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

NDC Listings For This Application#

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