dinutuximab Injection

Brand(s)
Unituxin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
United Therapeutics Corporation (2015-03-16)
Oldest Current Product
2015-03-10
License(s)
BLA
RxNORM
INJECTION\DINUTUXIMAB
SPL Active
INTRAVENOUS\INJECTION\DINUTUXIMAB
SPL Moiety
INTRAVENOUS\INJECTION\DINUTUXIMAB

product(s) by strength(s)

5 ml dinutuximab 3.5 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1663020014UnituxinBLAUnited Therapeutics Corporation2015-03-10DINUTUXIMABINTRAVENOUSINJECTION125516d66bdf0d-9d65-45de-ae5b-a58617c27492

application(s)

#idtitleapprovedtradenamesfda division
1125516dinutuximab Application2015-03-10UnituxinCDER

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1d66bdf0d-9d65-45de-ae5b-a58617c27492 (view SPL)These highlights do not include all the information needed to use UNITUXIN safely and effectively. See Full Prescribing Information for UNITUXIN. UNITUXIN (dinutuximab) injection, for intravenous useInitial U.S. Approval: 2015prescriptionHuman PrescriptionUnited Therapeutics Corporation2015-03-161663020014

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII