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General MedicationsORALStandard

LYBALVI

OLANZAPINE; SAMIDORPHAN L-MALATE

Standard Dose
5MG;EQ 10MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview LYBALVI is listed in Drugs@FDA under application 213378 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient OLANZAPINE; SAMIDORPHAN L-MALATE Form and strength TABLET;ORAL - 5MG;EQ 10MG BASE Sponsor ALKERMES INC Submission history Latest submission status date: 2026-01-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview LYBALVI is listed in Drugs@FDA under application 213378 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OLANZAPINE; SAMIDORPHAN L-MALATE Form and strength TABLET;ORAL - 5MG;EQ 10MG BASE Sponsor ALKERMES INC Submission history Latest submission status date: 2026-01-30 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.