irinotecan liposomal Injection

Brand(s)
Onivyde
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merrimack Pharmaceuticals (2015-11-02)
Oldest Current Product
2015-10-22
License(s)
NDA
RxNORM
INJECTION\IRINOTECAN LIPOSOMAL
FDAOB
IV (INFUSION)\INJECTABLE, LIPOSOMAL\IRINOTECAN HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION\IRINOTECAN HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION\IRINOTECAN

product(s) by strength(s)

10 ml irinotecan hydrochloride liposome 4.3 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1691710398OnivydeNDAMerrimack Pharmaceuticals2015-10-22IRINOTECAN HYDROCHLORIDEINTRAVENOUSINJECTIONNDA20779352ef5879-4cb5-443a-a355-5de14c497f22

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA207793ONIVYDEMERRIMACK PHARMACEUTICALS INC2015-10-22NEW PRODUCT [2018-10-22]NDA207793_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA207793_001RXIRINOTECAN HYDROCHLORIDE (EQ 43MG BASE/10ML)INJECTABLE, LIPOSOMALTrue2015-10-22ONIVYDE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
152ef5879-4cb5-443a-a355-5de14c497f22 (view SPL)These highlights do not include all the information needed to use ONIVYDE safely and effectively. See full prescribing information for ONIVYDE ONIVYDE (irinotecan liposome injection) , for intravenous use Initial U.S. Approval: 1996prescriptionHuman PrescriptionMerrimack Pharmaceuticals2015-11-024691710398

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