FDA.reportPublic FDA data

Application 206317

Type
NDA
Sponsor
ROCKWELL MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIFERICFERRIC PYROPHOSPHATE CITRATESOLUTION;INTRAVENOUS27.2MG IRON/5ML (5.44MG IRON/ML)YesYes
002TRIFERICFERRIC PYROPHOSPHATE CITRATESOLUTION;INTRAVENOUS272MG IRON/50ML (5.44MG IRON/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57278-314TrifericFERRIC PYROPHOSPHATERockwell Medical, IncNDACurrent
57278-314TrifericFERRIC PYROPHOSPHATERockwell Medical, IncNDACurrent
57278-314TrifericFERRIC PYROPHOSPHATERockwell Medical, IncNDACurrent
57278-316TrifericFerric Pyrophosphate CitrateRockwell Medical, IncNDACurrent
57278-316TrifericFerric Pyrophosphate CitrateRockwell Medical, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59309SUPPL2019-07-11
53580SUPPL2018-04-01
53574SUPPL2018-04-01
50111SUPPL2017-10-19
50062SUPPL2017-10-17
44943ORIG2016-03-02
43515ORIG2016-03-02
19714ORIG2015-01-29
10559ORIG2015-01-26