Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206317
Company: ROCKWELL MEDICAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIFERIC FERRIC PYROPHOSPHATE CITRATE 27.2MG IRON/5ML (5.44MG IRON/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
TRIFERIC FERRIC PYROPHOSPHATE CITRATE 272MG IRON/50ML (5.44MG IRON/ML) SOLUTION;INTRAVENOUS Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/23/2015 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206317s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206317Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206317Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206317Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2019 SUPPL-12 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206317Orig1s012ltr.pdf
03/29/2018 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206317s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206317Orig1s010ltr.pdf
10/16/2017 SUPPL-9 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206317s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206317Orig1s009ltr.pdf
07/28/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/12/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/16/2016 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/10/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/29/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206317s010lbl.pdf
10/16/2017 SUPPL-9 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206317s009lbl.pdf
01/23/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206317s000lbl.pdf

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