Details for New Drug Application (NDA): 215793
✉ Email this page to a colleague
NDA 215793 describes ZUSDURI, which is a drug marketed by Urogen Pharma and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ZUSDURI profile page.
The generic ingredient in ZUSDURI is mitomycin. There are seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
The generic ingredient in ZUSDURI is mitomycin. There are seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
Summary for 215793
| Tradename: | ZUSDURI |
| Applicant: | Urogen Pharma |
| Ingredient: | mitomycin |
| Patents: | 4 |
Medical Subject Heading (MeSH) Categories for 215793
Suppliers and Packaging for NDA: 215793
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZUSDURI | mitomycin | POWDER;INTRAVESICAL | 215793 | NDA | UroGen Pharma, Inc | 72493-106 | 72493-106-03 | 1 KIT in 1 CARTON (72493-106-03) * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72493-104-40) * 60 mL in 1 VIAL, SINGLE-DOSE (72493-105-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVESICAL | Strength | 40MG/VIAL | ||||
| Approval Date: | Jun 12, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 12, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 10,039,832 | Patent Expiration: | Jan 20, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER | ||||||||
| Patent: | 12,440,568 | Patent Expiration: | Jan 20, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER | ||||||||
Complete Access Available with Subscription
