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General MedicationsORALStandard

LUMRYZ

SODIUM OXYBATE

Standard Dose
6GM/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary

Approval overview LUMRYZ is listed in Drugs@FDA under application 214755 (NDA).

Review priority: N/A Marketing status: Prescription Active ingredient SODIUM OXYBATE Form and strength FOR SUSPENSION, EXTENDED RELEASE;ORAL - 6GM/PACKET Sponsor AVADEL CNS Submission history Latest submission status date: 2025-03-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview LUMRYZ is listed in Drugs@FDA under application 214755 (NDA). Review priority: N/A Marketing status: Prescription Active ingredient SODIUM OXYBATE Form and strength FOR SUSPENSION, EXTENDED RELEASE;ORAL - 6GM/PACKET Sponsor AVADEL CNS Submission history Latest submission status date: 2025-03-10 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.
LUMRYZ (SODIUM OXYBATE) | Drug Monograph | MedicHelpline