ferric citrate Oral Tablet

Brand(s)
Auryxia
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Keryx Biopharmaceuticals, Inc. (2015-08-14)
Oldest Current Product
2014-09-17
License(s)
NDA
RxNORM
ORAL TABLET\FERRIC CITRATE
FDAOB
ORAL\TABLET\FERRIC CITRATE
SPL Active
ORAL\TABLET, COATED\TETRAFERRIC TRICITRATE DECAHYDRATE
SPL Moiety
ORAL\TABLET, COATED\FERRIC CATION

product(s) by strength(s)

ferric citrate 1000 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1599220631AuryxiaNDAKeryx Biopharmaceuticals, Inc.2014-09-17TETRAFERRIC TRICITRATE DECAHYDRATEORALTABLET, COATEDNDA205874aadd18e0-3752-11e4-8510-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA205874AURYXIAKERYX BIOPHARMACEUTICALS INC2014-09-05p8093423, CONTROL OF SERUM PHOSPHOROUS LEVELS
p5753706, CONTROL OF SERUM PHOSPHOROUS LEVELS, SUBSTANCE
p8609896, SUBSTANCE
p9050316, CONTROL OF SERUM PHOSPHOROUS LEVELS
p8901349, CONTROL OF SERUM PHOSPHOROUS LEVELS
p8754257, SUBSTANCE
p8846976, CONTROL OF SERUM PHOSPHOROUS LEVELS
p8754258, SUBSTANCE
p8338642, CONTROL OF SERUM PHOSPHOROUS LEVELS, SUBSTANCE
p8299298, SUBSTANCE
p7767851, SUBSTANCE
NDA205874_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205874_001RXFERRIC CITRATE (EQ 210MG IRON)ORALTABLETTrue2014-09-05AURYXIA

patent(s)

#idexpiration dateapplication(s)
1p5753706 (view patent)2017-02-03NDA205874
2p7767851 (view patent)2024-02-18NDA205874
3p8093423 (view patent)2026-04-21NDA205874
4p8299298 (view patent)2024-02-18NDA205874
5p8338642 (view patent)2024-02-18NDA205874
6p8609896 (view patent)2024-02-18NDA205874
7p8754257 (view patent)2024-02-18NDA205874
8p8754258 (view patent)2024-02-18NDA205874
9p8846976 (view patent)2024-02-18NDA205874
10p8901349 (view patent)2024-02-18NDA205874
11p9050316 (view patent)2024-02-18NDA205874

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1aadd18e0-3752-11e4-8510-0800200c9a66 (view SPL)These highlights do not include all the information needed to use AURYXIA safely and effectively. See full prescribing information for AURYXIA. AURYXIA (ferric citrate) tablets, for oral use Initial U.S. Approval: 2014prescriptionHuman PrescriptionKeryx Biopharmaceuticals, Inc.2015-08-147599220631

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