| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 215793 | NDA | UROGEN PHARMA | 001 | ZUSDURI | POWDER;INTRAVESICAL | 40MG/VIAL | MITOMYCIN | 2025-06-12 | Prescription | Yes | |
| 211728 | NDA | UROGEN PHARMA | 001 | JELMYTO | POWDER;PYELOCALYCEAL | 40MG/VIAL | MITOMYCIN | 2020-04-15 | Prescription | Yes |