deferasirox Oral Tablet

Brand(s)
Jadenu
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-10-23)
Oldest Current Product
2015-03-30
License(s)
NDA
RxNORM
ORAL TABLET\DEFERASIROX
FDAOB
ORAL\TABLET\DEFERASIROX
SPL Active
ORAL\TABLET, FILM COATED\DEFERASIROX
SPL Moiety
ORAL\TABLET, FILM COATED\DEFERASIROX

product(s) by strength(s)

deferasirox 180 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780655JadenuNDANovartis Pharmaceuticals Corporation2015-03-30DEFERASIROXORALTABLET, FILM COATEDNDA206910fee89140-fff1-4443-9f42-24ac004fcda1

deferasirox 360 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780656JadenuNDANovartis Pharmaceuticals Corporation2015-03-30DEFERASIROXORALTABLET, FILM COATEDNDA206910fee89140-fff1-4443-9f42-24ac004fcda1

deferasirox 90 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780654JadenuNDANovartis Pharmaceuticals Corporation2015-03-30DEFERASIROXORALTABLET, FILM COATEDNDA206910fee89140-fff1-4443-9f42-24ac004fcda1

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA206910JADENUNOVARTIS PHARMACEUTICALS CORP2015-03-30p6465504, SUBSTANCE
p6596750, METHOD OF TREATING CHRONIC IRON OVERLOAD
NDA206910_001, NDA206910_002, NDA206910_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206910_001RXDEFERASIROX (90MG)ORALTABLETFalse2015-03-30JADENU
2NDA206910_002RXDEFERASIROX (180MG)ORALTABLETFalse2015-03-30JADENU
3NDA206910_003RXDEFERASIROX (360MG)ORALTABLETTrue2015-03-30JADENU

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6465504 (view patent)2019-04-05NDA206910, NDA021882deferasirox Oral Suspension
2p6596750 (view patent)2017-06-24NDA206910, NDA021882deferasirox Oral Suspension

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1fee89140-fff1-4443-9f42-24ac004fcda1 (view SPL)These highlights do not include all the information needed to use JADENU safely and effectively. See full prescribing information for JADENU. JADENU (deferasirox) tablets, for oral use Initial U.S. Approval: 2005prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-10-234000780654, 000780655, 000780656

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