← FDA DRUG APPROVALS

FDA NDA · NDA211801

IBSRELA

tenapanor hydrochloride

Sponsor: ARDELYX INC

APPLICATION
NDA211801
TYPE
NDA
ORIGINAL APPROVAL
2019-09-12
LATEST ACTION
2025-05-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

IBSRELA · ReferencePrescription
TENAPANOR HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL

Approval history

2025-05-20Labeling · Supplement 14 · standard — Letter ↗AP
2025-01-10Labeling · Supplement 12 · standard — Letter ↗AP
2022-04-05Labeling · Supplement 4 · standard — Letter ↗AP
2021-05-19Labeling · Supplement 3 · standard — Label ↗AP
2021-03-05Labeling · Supplement 2 · standard — Letter ↗AP
2019-09-12Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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