← FDA Drug Approvals (Drugs@FDA)
ZUSDURI
NDA · New Drug Application · Sponsor: UROGEN PHARMA · Approved 2025-06-12
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown