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General MedicationsINHALATIONStandard

BREO ELLIPTA

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Standard Dose
0.05MG/INH;EQ 0.025MG BASE/INH
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview BREO ELLIPTA is listed in Drugs@FDA under application 204275 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient FLUTICASONE FUROATE; VILANTEROL TRIFENATATE Form and strength POWDER;INHALATION - 0.05MG/INH;EQ 0.025MG BASE/INH Sponsor GLAXO GRP LTD Submission history Latest submission status date: 2023-05-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview BREO ELLIPTA is listed in Drugs@FDA under application 204275 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient FLUTICASONE FUROATE; VILANTEROL TRIFENATATE Form and strength POWDER;INHALATION - 0.05MG/INH;EQ 0.025MG BASE/INH Sponsor GLAXO GRP LTD Submission history Latest submission status date: 2023-05-12 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
BREO ELLIPTA (FLUTICASONE FUROATE; VILANTEROL TRIFENATATE) | Drug Monograph | MedicHelpline