Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205874
Company: KERYX BIOPHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AURYXIA FERRIC CITRATE EQ 210MG IRON TABLET;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
09/05/2014 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/2014/205874s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205874Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205874Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205874Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/06/2017 SUPPL-13 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205874s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205874Orig1s013ltr.pdf
12/19/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/09/2016 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/02/2016 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/27/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/04/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/14/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/21/2015 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205874s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205874Orig1s004ltr.pdf
05/22/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/18/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/15/2014 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205874s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205874Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/06/2017 SUPPL-13 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205874s013lbl.pdf
07/21/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205874s004lbl.pdf
11/15/2014 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205874s001lbl.pdf
09/05/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205874s000lbl.pdf

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