Skip to contentApplication 210598
- Type
- NDA
- Sponsor
- MYLAN IRELAND LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | YUPELRI | REVEFENACIN | SOLUTION;INHALATION | 175MCG/3ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49502-806 | YUPELRI | revefenacin | Mylan Specialty L.P. | NDA | Current |
| 49502-806 | YUPELRI | revefenacin | Mylan Specialty L.P. | NDA | Current |
| 49502-806 | YUPELRI | revefenacin | Mylan Specialty L.P. | NDA | Current |
| 49502-806 | YUPELRI | revefenacin | Mylan Specialty L.P. | NDA | Current |
| 49502-806 | YUPELRI | revefenacin | Mylan Specialty L.P. | NDA | Current |
| 49502-806 | YUPELRI | revefenacin | Mylan Specialty L.P. | NDA | Current |
| 49502-806 | YUPELRI | revefenacin | Mylan Specialty L.P. | NDA | Current |
| 49502-806 | YUPELRI | revefenacin | Mylan Specialty L.P. | NDA | Current |
| 49502-806 | YUPELRI | revefenacin | Mylan Specialty L.P. | NDA | Current |
| 49502-806 | YUPELRI | revefenacin | Mylan Specialty L.P. | NDA | Current |
| 49502-806 | YUPELRI | revefenacin | Mylan Specialty L.P. | NDA | Current |
| 49502-806 | YUPELRI | revefenacin | Mylan Specialty L.P. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71154 | SUPPL | 2022-05-26 |
| 71151 | SUPPL | 2022-05-26 |
| 69266 | SUPPL | 2021-11-05 |
| 58829 | SUPPL | 2019-05-22 |
| 58827 | SUPPL | 2019-05-22 |
| 56752 | ORIG | 2018-12-17 |
| 56429 | ORIG | 2018-11-14 |
| 56399 | ORIG | 2018-11-09 |
| 56398 | ORIG | 2018-11-09 |