General MedicationsINHALATIONStandard

BREYNA

BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

Standard Dose

0.08MG/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 - 0.08MG/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 - 0.08MG/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.