Application Nr Approved Date Route Status External Links
NDA022007 None Respiratory (inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Perforomist Inhalation Solution Is A Long-Acting Beta 2 -Adrenergic Agonist (beta 2 -Agonist) Indicated For: • Long-Term, Twice Daily (morning And Evening) Administration In The Maintenance Treatment Of Bronchoconstriction In Patients With Chronic Obstructive Pulmonary Disease (copd), Including Chronic Bronchitis And Emphysema. ( 1.1 ) Important Limitations Of Use: • Perforomist Inhalation Solution Is Not Indicated To Treat Acute Deteriorations Of Chronic Obstructive Pulmonary Disease. ( 1.2 , 5.2 ) • Perforomist Inhalation Solution Is Not Indicated To Treat Asthma. ( 1.2 ) 1.1 Maintenance Treatment Of Copd Perforomist (formoterol Fumarate) Inhalation Solution Is Indicated For The Long-Term, Twice Daily (morning And Evening) Administration In The Maintenance Treatment Of Bronchoconstriction In Patients With Chronic Obstructive Pulmonary Disease (copd), Including Chronic Bronchitis And Emphysema. 1.2 Important Limitations Of Use Perforomist Inhalation Solution Is Not Indicated To Treat Acute Deteriorations Of Chronic Obstructive Pulmonary Disease [see Warnings And Precautions (5.2) ]. Perforomist Inhalation Solution Is Not Indicated To Treat Asthma. The Safety And Effectiveness Of Perforomist Inhalation Solution In Asthma Have Not Been Established.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Formoterol Fumarate FORMOTEROL FUMARATE ZINC856

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