FdaApplication
NDA 215793
Identifiers
- fda_app_no: NDA215793
Properties
| Property | Value |
|---|---|
| applicant_name | UROGEN PHARMA LTD |
| application_type | NDA |
| approval_date | 2025-06-12 |
Revenue by product
ZUSDURI
| Period | Revenue |
|---|---|
| Q2 2026 | $50.4M |
| Q1 2026 | $29.2M |
| Q4 2025 | $14.0M |
| Q3 2025 | $1.8M |
| Q2 2025 | $0.0M |
| Q1 2025 | $0.0M |
| Q4 2024 | $0.0M |
| Q3 2024 | $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 (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZUSDURI | MITOMYCIN | 40MG/VIAL | POWDER;INTRAVESICAL |
1 product