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General MedicationsORALStandard

ADDYI

FLIBANSERIN

Standard Dose
100MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview ADDYI is listed in Drugs@FDA under application 022526 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient FLIBANSERIN Form and strength TABLET;ORAL - 100MG Sponsor SPROUT PHARMS Submission history Latest submission status date: 2025-12-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview ADDYI is listed in Drugs@FDA under application 022526 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient FLIBANSERIN Form and strength TABLET;ORAL - 100MG Sponsor SPROUT PHARMS Submission history Latest submission status date: 2025-12-13 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.