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FDA NDA · NDA212122

BREZTRI

budesonide, glycopyrrolate, and formoterol fumarate

Sponsor: ASTRAZENECA AB

APPLICATION
NDA212122
TYPE
NDA
ORIGINAL APPROVAL
2020-07-23
LATEST ACTION
2026-04-27
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

BREZTRI AEROSPHERE · ReferencePrescription
BUDESONIDE 0.16MG/INH, FORMOTEROL FUMARATE 0.0048MG/INH, GLYCOPYRROLATE 0.009MG/INH · AEROSOL, METERED · INHALATION
BREZTRI AEROSPHERE · ReferencePrescription
BUDESONIDE 0.16MG/INH, FORMOTEROL FUMARATE 0.0048MG/INH, GLYCOPYRROLATE 0.018MG/INH · AEROSOL, METERED · INHALATION

Approval history

2026-04-27Efficacy · Supplement 9 · standard — Label ↗AP
2023-01-26Manufacturing (CMC) · Supplement 4 — Review ↗AP
2020-07-23UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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