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Application 220358
- Type
- NDA
- Sponsor
- VANDA PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BYSANTI | MILSAPERIDONE | TABLET;ORAL | 1MG | Yes | Yes |
| 002 | BYSANTI | MILSAPERIDONE | TABLET;ORAL | 2MG | Yes | No |
| 003 | BYSANTI | MILSAPERIDONE | TABLET;ORAL | 4MG | Yes | No |
| 004 | BYSANTI | MILSAPERIDONE | TABLET;ORAL | 6MG | Yes | No |
| 005 | BYSANTI | MILSAPERIDONE | TABLET;ORAL | 8MG | Yes | No |
| 006 | BYSANTI | MILSAPERIDONE | TABLET;ORAL | 10MG | Yes | No |
| 007 | BYSANTI | MILSAPERIDONE | TABLET;ORAL | 12MG | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85314 | ORIG | 2026-03-10 |
| 85313 | ORIG | 2026-03-10 |
| 85157 | ORIG | 2026-02-25 |
| 85114 | ORIG | 2026-02-24 |