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General MedicationsINHALATIONStandard

ANORO ELLIPTA

UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE

Standard Dose
EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ANORO ELLIPTA is listed in Drugs@FDA under application 203975 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE Form and strength POWDER;INHALATION - EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH Sponsor GLAXOSMITHKLINE Submission history Latest submission status date: 2023-06-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview ANORO ELLIPTA is listed in Drugs@FDA under application 203975 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE Form and strength POWDER;INHALATION - EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH Sponsor GLAXOSMITHKLINE Submission history Latest submission status date: 2023-06-02 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.