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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213931
Company: ARDELYX INC

Products on NDA 213931

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XPHOZAH	TENAPANOR HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
XPHOZAH	TENAPANOR HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	None	Yes	No
XPHOZAH	TENAPANOR HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213931

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/2023	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213931s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213931Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/213931Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2025	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213931s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213931Orig1s005ltr.pdf
03/21/2025	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213931s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213931Orig1s002ltr.pdf

Labels for NDA 213931

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2025	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213931s005lbl.pdf
03/21/2025	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213931s002lbl.pdf
10/17/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213931s000lbl.pdf

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