netupitant / palonosetron Oral Capsule

Brand(s)
Akynzeo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eisai Inc. (2015-05-21)
Oldest Current Product
2014-10-13
License(s)
NDA
RxNORM
ORAL CAPSULE\NETUPITANT:PALONOSETRON
FDAOB
ORAL\CAPSULE\NETUPITANT: PALONOSETRON HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\NETUPITANT: PALONOSETRON
SPL Moiety
ORAL\CAPSULE\NETUPITANT: PALONOSETRON

product(s) by strength(s)

netupitant 300 mg / palonosetron 0.5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560796AkynzeoNDAEisai Inc.2014-10-13NETUPITANT, PALONOSETRONORALCAPSULENDA2057182daa0c22-3051-4f12-a860-e5404c862760

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205718AKYNZEOHELSINN HEALTHCARE SA2014-10-10p5202333, PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING, SUBSTANCE
p6297375
p8623826, PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
p8951969, SUBSTANCE
NEW CHEMICAL ENTITY [2019-10-10]NDA205718_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205718_001RXNETUPITANT (300MG), PALONOSETRON HYDROCHLORIDE (EQ 0.5MG BASE)ORALCAPSULETrue2014-10-10AKYNZEO

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5202333 (view patent)2015-04-13NDA205718, NDA021372, NDA022233palonosetron Injectable Solution
palonosetron Oral Capsule
2p6297375 (view patent)2020-02-22NDA205718
3p8623826 (view patent)2030-11-18NDA205718
4p8951969 (view patent)2030-11-18NDA205718

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12daa0c22-3051-4f12-a860-e5404c862760 (view SPL)These highlights do not include all the information needed to use AKYNZEO safely and effectively. See full prescribing information for AKYNZEO. AKYNZEOTM (netupitant and palonosetron) capsules, for oral use Initial U.S. Approval: 2014prescriptionHuman PrescriptionEisai Inc.API MANUFACTURE, MANUFACTURE2015-05-216628560796

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