An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 205874
Company: KERYX BIOPHARMS

Summary Review

Products on NDA 205874

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205874

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
01/19/2024	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205874s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205874Orig1s029ltr.pdf
03/10/2021	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205874s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205874Orig1s027ltr.pdf
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

Labels for NDA 205874

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2024	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205874s029lbl.pdf
03/10/2021	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205874s027lbl.pdf
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

Top