FDA Approval for IBSRELA issued to ARDELYX INC
$ARDX
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 211801
Company: ARDELYX INC
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 |
Label is not available on this site. |
||
| 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 |
|---|---|---|---|---|---|
| 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 |