FDA NDA · NDA220290
BREZTRI AEROSPHERE
Sponsor: ASTRAZENECA AB
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APPLICATION
NDA220290
TYPE
NDA
ORIGINAL APPROVAL
2026-10-08
LATEST ACTION
2026-10-08
ROUTE
ORAL
DOSAGE FORM
INHALANT
MARKETING STATUS
Prescription
Products
BREZTRI AEROSPHEREPrescription
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE 160MCG/9MCG/4.8MCG · INHALANT · ORAL
Approval history
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →