FDA.reportPublic FDA data

Application 212860

Type
NDA
Sponsor
ROCKWELL MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIFERIC AVNUFERRIC PYROPHOSPHATE CITRATESOLUTION;INTRAVENOUS6.75MG IRON/4.5ML (1.5MG IRON/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57278-318Triferic AVNUferric pyrophosphate citrateRockwell Medical Inc.NDACurrent
57278-318Triferic AVNUferric pyrophosphate citrateRockwell Medical Inc.NDACurrent
60940-022Triferic Solution for Hemodialysisferric pyrophosphate citrateHolopack Verpackungstechnik GmgHNDACurrent
60940-029Triferic AVNUferric pyrophosphate citrateHolopack Verpackungstechnik GmgHNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74958SUPPL 2023-07-31
74954SUPPL 2023-07-31
64196ORIG2020-08-04
62372ORIG2020-03-31
62362ORIG2020-03-30