FDA.reportPublic FDA data

Application 208551

Type
NDA
Sponsor
ROCKWELL MEDICAL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIFERICFERRIC PYROPHOSPHATE CITRATEFOR SOLUTION;INTRAVENOUS272MG IRON/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57278-315TrifericFERRIC PYROPHOSPHATE CITRATERockwell Medical, IncNDACurrent
57278-315TrifericFERRIC PYROPHOSPHATE CITRATERockwell Medical, IncNDACurrent
57278-315TrifericFERRIC PYROPHOSPHATE CITRATERockwell Medical, IncNDACurrent
64811-315TrifericFERRIC PYROPHOSPHATE CITRATERopack Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53579SUPPL2018-04-01
53575SUPPL2018-04-01
50110SUPPL2017-10-19
50063SUPPL2017-10-17
46044ORIG2016-10-21
46043ORIG2016-10-21
19997ORIG2016-04-27
10658ORIG2016-04-27