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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205109
Company: VIFOR FRESENIUS

Summary Review

Products on NDA 205109

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VELPHORO	FERRIC OXYHYDROXIDE	EQ 500MG IRON	TABLET, CHEWABLE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205109

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/2013	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/2013/205109s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205109Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205109Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205109Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2020	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205109s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205109Orig1s008ltr.pdf
04/25/2018	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205109s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205109Orig1s006ltr.pdf
08/03/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205109s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205109Orig1s005ltr.pdf
06/12/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/24/2014	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205109s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205109Orig1s001ltr.pdf

Labels for NDA 205109

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205109s008lbl.pdf
04/25/2018	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205109s006lbl.pdf
04/25/2018	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205109s006lbl.pdf
08/03/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205109s005lbl.pdf
09/24/2014	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205109s001lbl.pdf
11/27/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205109s000lbl.pdf

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