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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206317
Company: ROCKWELL MEDICAL INC

Summary Review

Products on NDA 206317

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	Discontinued	None	Yes	No
TRIFERIC	FERRIC PYROPHOSPHATE CITRATE	272MG IRON/50ML (5.44MG IRON/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206317

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.

Labels for NDA 206317

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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