FdaApplication
NDA 213931
Identifiers
- fda_app_no: NDA213931
Properties
| Property | Value |
|---|---|
| applicant_name | ARDELYX INC |
| application_type | NDA |
| approval_date | 2023-10-17 |
Revenue by product
XPHOZAH
| Period | Revenue |
|---|---|
| Q2 2026 | $31.9M |
| Q1 2026 | $23.3M |
| Q4 2025 | $27.8M |
| Q3 2025 | $27.4M |
| Q2 2025 | $25.0M |
| Q1 2025 | $23.4M |
| Q4 2024 | $57.2M |
| Q3 2024 | $51.5M |
| Q2 2024 | $37.1M |
| Q1 2024 | $15.2M |
| Q4 2023 | $2.5M |
| Q3 2023 | $0.0M |
| Q2 2023 | $0.0M |
| Q1 2023 | $0.0M |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| XPHOZAH | TENAPANOR HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL |
| XPHOZAH | TENAPANOR HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL |
| XPHOZAH | TENAPANOR HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL |
3 products