Application 213801
- Type
- NDA
- Sponsor
- ASTELLAS PHARMA GLOBAL DEV INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MYRBETRIQ | MIRABEGRON | SUSPENSION;ORAL | 8MG/ML | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0469-5020 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-5020 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-5020 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-5020 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-5020 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
| 0469-5020 | Myrbetriq | mirabegron | Astellas Pharma US, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 69976 | ORIG | 2022-01-26 |
| 66919 | ORIG | 2021-03-30 |
| 66906 | ORIG | 2021-03-29 |