Application Nr Approved Date Route Status External Links
NDA212122 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Breztri Aerosphere Is Indicated For The Maintenance Treatment Of Patients With Chronic Obstructive Pulmonary Disease (Copd). Limitations Of Use: Breztri Aerosphere Is Not Indicated For The Relief Of Acute Bronchospasm Or For The Treatment Of Asthma [See Warnings And Precautions (5.1 , 5.2) ] . Breztri Aerosphere Is A Combination Of Budesonide, An Inhaled Corticosteroid (Ics); Glycopyrrolate, An Anticholinergic; And Formoterol Fumarate, A Long-Acting Beta 2 -Adrenergic Agonist (Laba), Indicated For The Maintenance Treatment Of Patients With Chronic Obstructive Pulmonary Disease (Copd). (1) Limitations Of Use: Not Indicated For The Relief Of Acute Bronchospasm Or For The Treatment Of Asthma. (1 , 5.1 , 5.2)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 3 Total)

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