Skip to contentApplication 213931
- Type
- NDA
- Sponsor
- ARDELYX INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XPHOZAH | TENAPANOR HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | Yes | No |
| 002 | XPHOZAH | TENAPANOR HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | Yes | No |
| 003 | XPHOZAH | TENAPANOR HYDROCHLORIDE | TABLET;ORAL | EQ 30MG BASE | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82591 | SUPPL | 2025-06-17 |
| 82587 | SUPPL | 2025-06-17 |
| 81715 | SUPPL | 2025-03-25 |
| 81704 | SUPPL | 2025-03-24 |
| 79581 | ORIG | 2024-09-12 |
| 75856 | ORIG | 2023-10-19 |
| 75837 | ORIG | 2023-10-18 |