palonosetron Oral Capsule

Brand(s)
Aloxi
Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2008-08-22
License(s)
NDA
RxNORM
ORAL CAPSULE\PALONOSETRON
FDAOB
ORAL\CAPSULE\PALONOSETRON HYDROCHLORIDE
SPL Active
ORAL\CAPSULE, GELATIN COATED\PALONOSETRON HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\PALONOSETRON

product(s) by strength(s)

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1628560799AloxiNDAEisai Inc.2008-08-22PALONOSETRON HYDROCHLORIDEORALCAPSULE, GELATIN COATEDNDA022233bd06f321-bb42-4748-92f3-d59626b540e0

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1NDA022233ALOXITrueHELSINN HEALTHCARE SA2008-08-22p5202333, PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING, SUBSTANCENDA022233_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022233_001discontinuedPALONOSETRON HYDROCHLORIDE (EQ 0.5MG BASE)ORALCAPSULEFalse2008-08-22ALOXI

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5202333 (view patent)2015-04-13NDA022233, NDA021372, NDA205718palonosetron Injectable Solution
netupitant / palonosetron Oral Capsule

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1bd06f321-bb42-4748-92f3-d59626b540e0 (view SPL)These highlights do not include all the information needed to use ALOXI Capsules safely and effectively. See full prescribing information for ALOXI. ALOXI (palonosetron HCl) Capsules Initial U.S. Approval: 2003prescriptionHuman PrescriptionEisai Inc.2014-09-304628560799

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