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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211801
Company: ARDELYX INC

Medication Guide

Products on NDA 211801

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBSRELA	TENAPANOR HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211801

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/12/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211801s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211801Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211801Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2022	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211801s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211801Orig1s004ltr.pdf
05/19/2021	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211801s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211801Orig1s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211801Orig1s003.pdf
03/05/2021	SUPPL-2	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211801Orig1s002ltr.pdf

Labels for NDA 211801

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2022	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211801s004lbl.pdf
04/05/2022	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211801s004lbl.pdf
05/19/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211801s003lbl.pdf
05/19/2021	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211801s003lbl.pdf
09/12/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211801s000lbl.pdf

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