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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211801
Company: ARDELYX INC
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
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-Medication Guide, Labeling-Package Insert 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
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211801s003lbl.pdf
05/19/2021 SUPPL-3 Labeling-Package Insert 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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