FDA Approval for XPHOZAH issued to ARDELYX INC
$ARDX
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 213931
Company: ARDELYX INC
Company: ARDELYX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XPHOZAH | TENAPANOR | 10MG | TABLET; ORAL | Prescription | None | No | No |
| XPHOZAH | TENAPANOR | 20MG | TABLET; ORAL | Prescription | None | No | No |
| XPHOZAH | TENAPANOR | 30MG | TABLET; ORAL | Prescription | None | No | No |
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) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213931s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213931Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/17/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213931s000lbl.pdf |