Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205109
Company: VIFOR FRESENIUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VELPHORO SUCROFERRIC OXYHYDROXIDE 500MG TABLET, CHEWABLE;ORAL Prescription None Yes Yes
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
04/25/2018 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/25/2018 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205109s006lbl.pdf
04/25/2018 SUPPL-6 Labeling-Container/Carton Labels 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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