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General MedicationsINHALATIONStandard

BREZTRI AEROSPHERE

BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Standard Dose
0.16MG/INH;0.0048MG/INH;0.009MG/INH
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary

Approval overview BREZTRI AEROSPHERE is listed in Drugs@FDA under application 212122 (NDA).

Review priority: N/A Marketing status: Prescription Active ingredient BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE Form and strength AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0048MG/INH;0.009MG/INH Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2023-01-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview BREZTRI AEROSPHERE is listed in Drugs@FDA under application 212122 (NDA). Review priority: N/A Marketing status: Prescription Active ingredient BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE Form and strength AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0048MG/INH;0.009MG/INH Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2023-01-26 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.