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General MedicationsORALStandard

SUNOSI

SOLRIAMFETOL HYDROCHLORIDE

Standard Dose
EQ 150MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SUNOSI is listed in Drugs@FDA under application 211230 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SOLRIAMFETOL HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 150MG BASE Sponsor AXSOME MALTA Submission history Latest submission status date: 2023-06-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview SUNOSI is listed in Drugs@FDA under application 211230 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SOLRIAMFETOL HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 150MG BASE Sponsor AXSOME MALTA Submission history Latest submission status date: 2023-06-28 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.