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General MedicationsORALStandard

SYMPROIC

NALDEMEDINE TOSYLATE

Standard Dose
EQ 0.2MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SYMPROIC is listed in Drugs@FDA under application 208854 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NALDEMEDINE TOSYLATE Form and strength TABLET;ORAL - EQ 0.2MG BASE Sponsor BDSI Submission history Latest submission status date: 2025-07-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview SYMPROIC is listed in Drugs@FDA under application 208854 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NALDEMEDINE TOSYLATE Form and strength TABLET;ORAL - EQ 0.2MG BASE Sponsor BDSI Submission history Latest submission status date: 2025-07-15 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.