Application Nr Approved Date Route Status External Links
NDA022383 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Arcapta Neohaler Is A Long-Acting Beta 2 -Adrenergic Agonist Indicated For: The Long-Term, Once-Daily Maintenance Bronchodilator Treatment Of Airflow Obstruction In Patients With Chronic Obstructive Pulmonary Disease (Copd), Including Chronic Bronchitis And/or Emphysema. ( 1.1 ) Important Limitations: Arcapta Neohaler Is Not Indicated To Treat Acute Deteriorations Of Chronic Obstructive Pulmonary Disease. ( 1.2 ) Arcapta Neohaler Is Not Indicated For Asthma. ( 1.2 ) 1.1 Maintenance Treatment Of Copd Arcapta Neohaler Is A Long-Acting Beta 2 -Agonist Indicated For Long-Term, Once-Daily Maintenance Bronchodilator Treatment Of Airflow Obstruction In Patients With Chronic Obstructive Pulmonary Disease (Copd), Including Chronic Bronchitis And/or Emphysema. 1.2 Important Limitations Of Use Arcapta Neohaler Is Not Indicated To Treat Acute Deteriorations Of Chronic Obstructive Pulmonary Disease [ See Warnings And Precautions ( 5.2 ) ]. Arcapta Neohaler Is Not Indicated To Treat Asthma. The Safety And Effectiveness Of Arcapta Neohaler In Asthma Have Not Been Established.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Indacaterol Maleate INDACATEROL MALEATE ZINC35801098

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