Skip to contentApplication 211728
- Type
- NDA
- Sponsor
- UROGEN PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | JELMYTO | MITOMYCIN | SOLUTION;PYELOCALYCEAL | | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69605-103 | JELMYTO | mitomycin | CENEXI - BLA | NDA | Current |
| 72493-103 | JELMYTO | mitomycin | UroGen Pharma, Inc. | NDA | Current |
| 72493-103 | JELMYTO | mitomycin | UroGen Pharma, Inc. | NDA | Current |
| 72493-103 | JELMYTO | mitomycin | UroGen Pharma, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79829 | SUPPL | 2024-10-07 |
| 79826 | SUPPL | 2024-10-07 |
| 78476 | SUPPL | 2024-05-15 |
| 78475 | SUPPL | 2024-05-15 |
| 65933 | SUPPL | 2021-01-19 |
| 65911 | SUPPL | 2021-01-15 |
| 63482 | ORIG | 2020-06-11 |
| 62582 | ORIG | 2020-04-16 |
| 62580 | ORIG | 2020-04-15 |