FDA Approval for XPHOZA™ issued to ARDELYX INC
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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 |
|---|---|---|---|---|---|---|---|
| XPHOZA™ | TENAPANOR | 10MG | TABLET; ORAL | Prescription | None | No | No |
| XPHOZA™ | TENAPANOR | 20MG | TABLET; ORAL | Prescription | None | No | No |
| XPHOZA™ | 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 | Labeling | STANDARD |
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