deferiprone Oral Solution

Brand(s)
Ferriprox
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Apo-Pharma Usa, Inc (2015-09-15)
Oldest Current Product
2015-09-09
License(s)
NDA
RxNORM
ORAL SOLUTION\DEFERIPRONE
FDAOB
ORAL\SOLUTION\DEFERIPRONE
SPL Active
ORAL\SOLUTION\DEFERIPRONE
SPL Moiety
ORAL\SOLUTION\DEFERIPRONE

product(s) by strength(s)

deferiprone 100 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1526094502FerriproxNDAApo-Pharma Usa, Inc2015-09-09DEFERIPRONEORALSOLUTIONNDA20803097f7bfcb-8666-464c-87b6-9621ceca5ee2

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA208030FERRIPROXAPOPHARMA INC2015-09-09p8703156, METHOD OF TREATING CHRONIC IRON OVERLOAD, SUBSTANCE
p7049328, METHOD OF TREATING CHRONIC IRON OVERLOAD
NEW CHEMICAL ENTITY [2016-10-14]
ORPHAN DRUG EXCLUSIVITY [2016-10-14]
NDA208030_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA208030_001RXDEFERIPRONE (100MG/ML)ORALSOLUTIONTrue2015-09-09FERRIPROX

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7049328 (view patent)2021-06-28NDA208030, NDA021825deferiprone Oral Tablet
2p8703156 (view patent)2029-10-29NDA208030

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
197f7bfcb-8666-464c-87b6-9621ceca5ee2 (view SPL)These highlights do not include all the information needed to use FERRIPROX safely and effectively. See full prescribing information for FERRIPROX. FERRIPROX (deferiprone) oral solution, for oral useInitial U.S. Approval: 2011prescriptionHuman PrescriptionApo-Pharma Usa, Incanalysis, manufacture2015-09-159526094502

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