sucroferric oxyhydroxide Chewable Tablet

Brand(s)
Velphoro
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Fresenius Medical Care North America (2014-09-10)
Oldest Current Product
2013-11-27
License(s)
NDA
RxNORM
CHEWABLE TABLET\SUCROFERRIC OXYHYDROXIDE
FDAOB
ORAL\TABLET, CHEWABLE\SUCROFERRIC OXYHYDROXIDE
SPL Active
ORAL\TABLET, CHEWABLE\FERRIC OXYHYDROXIDE
SPL Moiety
ORAL\TABLET, CHEWABLE\IRON

product(s) by strength(s)

sucroferric oxyhydroxide 500 mg chewable tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1492300645VelphoroNDAFresenius Medical Care North America2013-11-27FERRIC OXYHYDROXIDEORALTABLET, CHEWABLENDA205109237da26c-f38c-4faa-93ad-735e71c9d0c1

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205109VELPHOROVIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE2013-11-27p6174442, CONTROL OF PHOSPHOROUS LEVELS IN PATIENTSNEW PRODUCT [2016-11-27]NDA205109_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205109_001RXSUCROFERRIC OXYHYDROXIDE (500MG)ORALTABLET, CHEWABLETrue2013-11-27VELPHORO

patent(s)

#idexpiration dateapplication(s)
1p6174442 (view patent)2016-12-19NDA205109

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1237da26c-f38c-4faa-93ad-735e71c9d0c1 (view SPL)These highlights do not include all the information needed to use VELPHORO safely and effectively. See full prescribing information for VELPHORO. VELPHORO (sucroferric oxyhydroxide) chewable tablet for oral use Initial U.S. Approval: 2013prescriptionHuman PrescriptionFresenius Medical Care North America2014-09-104492300645

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