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General MedicationsORALStandard

BYSANTI

MILSAPERIDONE

Standard Dose
10MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BYSANTI is listed in Drugs@FDA under application 220358 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MILSAPERIDONE Form and strength TABLET;ORAL - 10MG Sponsor VANDA PHARMS INC Submission history Latest submission status date: 2026-02-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview BYSANTI is listed in Drugs@FDA under application 220358 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MILSAPERIDONE Form and strength TABLET;ORAL - 10MG Sponsor VANDA PHARMS INC Submission history Latest submission status date: 2026-02-20 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.