Application Nr Approved Date Route Status External Links
NDA208294 None Respiratory (inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Bevespi Aerosphere Is A Combination Of Glycopyrrolate And Formoterol Fumarate Indicated For The Maintenance Treatment Of Patients With Chronic Obstructive Pulmonary Disease (copd), Including Chronic Bronchitis And/or Emphysema. Important Limitation Of Use: Bevespi Aerosphere Is Not Indicated For The Relief Of Acute Bronchospasm Or For The Treatment Of Asthma [see Warnings And Precautions ( 5.1 , 5.2 )] . Bevespi Aerosphere Is A Combination Of 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 ) Limitation 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 ( 2 Total)

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