Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 220358
Company: VANDA PHARMS INC
Company: VANDA PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BYSANTI | MILSAPERIDONE | 1MG | TABLET; ORAL | Prescription | None | No | No |
| BYSANTI | MILSAPERIDONE | 2MG | TABLET; ORAL | Prescription | None | No | No |
| BYSANTI | MILSAPERIDONE | 4MG | TABLET; ORAL | Prescription | None | No | No |
| BYSANTI | MILSAPERIDONE | 6MG | TABLET; ORAL | Prescription | None | No | No |
| BYSANTI | MILSAPERIDONE | 8MG | TABLET; ORAL | Prescription | None | No | No |
| BYSANTI | MILSAPERIDONE | 10MG | TABLET; ORAL | Prescription | None | No | No |
| BYSANTI | MILSAPERIDONE | 12MG | TABLET; ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/20/2026 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220358Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220358Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/20/2026 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220358Orig1s000lbl.pdf |