Active ingredient
Milsaperidone
10 finished FDA listings contain Milsaperidone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MILSAPERIDONE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 1 mg/1 · 10 mg/1 · 12 mg/1 · 2 mg/1 · 4 mg/1 · 6 mg/1 · 8 mg/1
- Brand names in FDA listings
- Bysanti
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2745765
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 220358 | VANDA PHARMS INC | 2026-02-20 | 10 |
Official labeling on DailyMed
- BYSANTI (MILSAPERIDONE) TABLET BYSANTI (MILSAPERIDONE) KIT [VANDA PHARMACEUTICALS INC.] · version 2 · 2026-07-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.