Composition
- Active ingredients
- MILSAPERIDONE 8MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- MILSAPERIDONE 4MG · TabletNDA220358-003 · Prescription
- MILSAPERIDONE 1MG · TabletNDA220358-001 · Prescription
- MILSAPERIDONE 10MG · TabletNDA220358-006 · Prescription
- MILSAPERIDONE 6MG · TabletNDA220358-004 · Prescription
- MILSAPERIDONE 2MG · TabletNDA220358-002 · Prescription
- MILSAPERIDONE 12MG · TabletNDA220358-007 · Prescription
- MILSAPERIDONE 8MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA220358.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Bysanti
- Active substance
- milsaperidone
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Vanda Pharms Inc
- Status
- Prescription
- FDA approval
- 20 Feb 2026
- Application
- NDA220358-005