Register entry
- Registered sites
- 0
- Active NDC listings
- 2
- Labeller names
- 2
- Live patents
- 7
- Exclusivities
- 2
- Countries
- 0
Catalogue
Drug listings by form and route
22 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.
| Dosage form | NDCs |
|---|---|
| kit | 2 |
| Route | NDCs |
|---|
| Labeller name on the listing | NDCs |
|---|---|
| urogen pharma, inc | 1 |
| urogen pharma, inc. | 1 |
Exclusivity
Patents and exclusivities
7| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10039832 | ZUSDURImitomycin | use | Jan 2031 |
| 12268745 | JELMYTOmitomycin | use | Jan 2031 |
| 12440568 | ZUSDURImitomycin | use | Jan 2031 |
| 9040074 | JELMYTO, ZUSDURImitomycin | product | Jan 2031 |
| 9950069 | JELMYTO, ZUSDURImitomycin | product | Jan 2031 |
| Product | Exclusivity | Until |
|---|---|---|
| JELMYTOMITOMYCIN | ODE-289 Orphan drug | Apr 2027 |
| ZUSDURIMITOMYCIN | NP New product | Jun 2028 |
Catalogue
Marketed products
2| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| JELMYTO | mitomycin | kit | 72493-103NDA |
| ZUSDURI | Mitomycin | kit | 72493-106NDA |
Compare
Other companies listing mitomycin
- Hikma Pharmaceuticals USA Inc.4 sites · 763 NDC
- Concord Biotech Limited3 sites · 42 NDC
- Zhejiang Hisun Pharmaceutical Co., Ltd.3 sites · 27 NDC
- MEDISCA Inc.2 sites · 305 NDC
- ACCORD HEALTHCARE LIMITED2 sites · 242 NDC
- Bryant Ranch Prepack1 site · 4,357 NDC
- Darmerica, LLC1 site · 212 NDC
- Qingdao Biopeptek Co Ltd1 site · 110 NDC
- Wuxi Fortune Pharmaceutical Co., Ltd.1 site · 5 NDC
- BluePoint Laboratories Inc.0 sites · 352 NDC
Enquiry
Common questions
- Is UroGen Pharma, Inc. FDA approved?
- UroGen Pharma, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does UroGen Pharma, Inc. make?
- 2 products are listed under UroGen Pharma, Inc. in the openFDA NDC Directory, most often as kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.