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General MedicationsINHALATIONStandard

BREYNA

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Standard Dose
0.16MG/INH;0.0045MG/INH
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BREYNA is listed in Drugs@FDA under application 211699 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE Form and strength AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH Sponsor MYLAN Submission history Latest submission status date: 2022-03-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview BREYNA is listed in Drugs@FDA under application 211699 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE Form and strength AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH Sponsor MYLAN Submission history Latest submission status date: 2022-03-15 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.