# ZUSDURI
> **NDA215793** · New Drug Application · Sponsor: UROGEN PHARMA · Approved 2025-06-12
## Drug
- **FDA Application Number:** NDA215793
- **Application type:** New Drug Application
- **Brand name:** ZUSDURI
- **Generic name:** MITOMYCIN
- **Active ingredients:** MITOMYCIN
- **Dosage form:** POWDER
- **Route:** INTRAVESICAL
- **Marketing status:** Prescription
- **Sponsor:** UROGEN PHARMA
- **Manufacturer:** UroGen Pharma, Inc
- **First approval:** 2025-06-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215793)
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