Skip to contentApplication 209529
- Type
- NDA
- Sponsor
- ASTELLAS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VESICARE LS | SOLIFENACIN SUCCINATE | SUSPENSION;ORAL | 5MG/5ML(1MG/ML) | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51248-250 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-250 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
| 51248-250 | VESIcare | solifenacin succinate | Astellas Pharma US, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 64006 | ORIG | 2020-07-22 |
| 63320 | ORIG | 2020-05-28 |
| 63305 | ORIG | 2020-05-27 |