trabectedin Injection

Brand(s)
Yondelis
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Products, Lp (2015-10-23)
Oldest Current Product
2015-10-23
License(s)
NDA
RxNORM
INJECTION\TRABECTEDIN
FDAOB
IV (INFUSION)\POWDER\TRABECTEDIN\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TRABECTEDIN
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TRABECTEDIN

product(s) by strength(s)

trabectedin 1 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596760610YondelisNDAJanssen Products, Lp2015-10-23TRABECTEDININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA207953472bd78e-be17-4b9d-90f4-9482c3aec9ff

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA207953YONDELISJANSSEN PRODUCTS LP2015-10-23NEW CHEMICAL ENTITY [2020-10-23]NDA207953_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA207953_001RXTRABECTEDIN (1MG/VIAL)POWDERTrue2015-10-23YONDELIS

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1472bd78e-be17-4b9d-90f4-9482c3aec9ff (view SPL)These highlights do not include all the information needed to use YONDELIS safely and effectively. See full prescribing information for YONDELIS. YONDELIS (trabectedin) for injection, for intravenous use Initial U.S. Approval: 2015prescriptionHuman PrescriptionJanssen Products, LpAPI MANUFACTURE, MANUFACTURE2015-10-231596760610

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