ferric pyrophosphate Injectable Solution

Brand(s)
Triferic
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Rockwell Medical, Inc (2015-09-09)
Oldest Current Product
2015-02-06
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\FERRIC PYROPHOSPHATE
FDAOB
IV (INFUSION)\SOLUTION\FERRIC PYROPHOSPHATE CITRATE\rdfq
SPL Active
PARENTERAL\SOLUTION\FERRIC PYROPHOSPHATE CITRATE
SPL Moiety
PARENTERAL\SOLUTION\FERRIC CATION

product(s) by strength(s)

ferric pyrophosphate citrate 5.44 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1572780314TrifericNDARockwell Medical, Inc2015-02-06FERRIC PYROPHOSPHATE CITRATEPARENTERALSOLUTIONNDA206317bef06c1f-eda6-4cfa-a578-379f23964599

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA206317TRIFERICROCKWELL MEDICAL INC2015-01-23p7816404, METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT, SUBSTANCE
p6689275, METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT
p6779468, METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT
NDA206317_001, NDA206317_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA206317_001RXFERRIC PYROPHOSPHATE CITRATE (27.2MG IRON/5ML)SOLUTIONTrue2015-01-23TRIFERIC
2NDA206317_002RXFERRIC PYROPHOSPHATE CITRATE (272MG IRON/50ML)SOLUTIONFalse2015-09-04TRIFERIC

patent(s)

#idexpiration dateapplication(s)
1p6689275 (view patent)2016-12-31NDA206317
2p6779468 (view patent)2016-12-31NDA206317
3p7816404 (view patent)2029-04-17NDA206317

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1bef06c1f-eda6-4cfa-a578-379f23964599 (view SPL)These highlights do not include all the information needed to use TRIFERIC safely and effectively. See full prescribing information for TRIFERIC. TRIFERIC (ferric pyrophosphate citrate) solution, for addition to bicarbonate concentrateInitial U.S. Approval: [2015]prescriptionHuman PrescriptionRockwell Medical, Inc2015-09-092572780314

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