FdaApplication
NDA 211728
Identifiers
- fda_app_no: NDA211728
Properties
| Property | Value |
|---|---|
| applicant_name | UROGEN PHARMA LTD |
| application_type | NDA |
| approval_date | 2020-04-15 |
Revenue by product
JELMYTO
| Period | Revenue |
|---|---|
| Q2 2026 | $22.0M |
| Q1 2026 | $21.7M |
| Q4 2025 | $23.8M |
| Q3 2025 | $25.7M |
| Q2 2025 | $24.2M |
| Q1 2025 | $20.3M |
| Q4 2024 | $24.6M |
| Q3 2024 | $25.2M |
| Q2 2024 | $21.8M |
| Q1 2024 | $18.8M |
| Q4 2023 | $23.5M |
| Q3 2023 | $20.9M |
| Q2 2023 | $21.1M |
| Q1 2023 | $17.2M |
| Q4 2022 | $18.1M |
| Q3 2022 | $16.1M |
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 |
|---|---|---|---|
| JELMYTO | MITOMYCIN | 40MG/VIAL | POWDER;PYELOCALYCEAL |
1 product