← FDA DRUG APPROVALS

FDA NDA · NDA220358

BYSANTI

milsaperidone

Sponsor: VANDA PHARMS INC

APPLICATION
NDA220358
TYPE
NDA
ORIGINAL APPROVAL
2026-02-20
LATEST ACTION
2026-02-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BYSANTI · ReferencePrescription
MILSAPERIDONE 4MG · TABLET · ORAL
BYSANTI · ReferencePrescription
MILSAPERIDONE 1MG · TABLET · ORAL
BYSANTI · ReferencePrescription
MILSAPERIDONE 10MG · TABLET · ORAL
BYSANTI · ReferencePrescription
MILSAPERIDONE 6MG · TABLET · ORAL
BYSANTI · ReferencePrescription
MILSAPERIDONE 2MG · TABLET · ORAL
BYSANTI · ReferencePrescription
MILSAPERIDONE 12MG · TABLET · ORAL
BYSANTI · ReferencePrescription
MILSAPERIDONE 8MG · TABLET · ORAL

Approval history

2026-02-20Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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