ZUSDURI — FDA application NDA215793
Listed sponsor: UROGEN PHARMA · URGN company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | ZUSDURI | MITOMYCIN | POWDER | INTRAVESICAL | 40MG/VIAL | Prescription | not listed | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10039832 | 001 | listed patent expiry date: 2031-01-20 | U-4256 |
| Patent 12440568 | 001 | listed patent expiry date: 2031-01-20 | U-4256 |
| Patent 9040074 | 001 | listed patent expiry date: 2031-01-20 | drug product, U-4256 |
| Patent 9950069 | 001 | listed patent expiry date: 2031-01-20 | drug product, U-4256 |
| Exclusivity NP | 001 | listed exclusivity date: 2028-06-12 | FDA code as listed |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- MITOMYCIN · UNII not resolved · no lmmol compound match
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.