Application Nr Approved Date Route Status External Links
NDA207930 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Utibron ® Neohaler ® Is A Combination Of Indacaterol And Glycopyrrolate Indicated For The Long-Term, Maintenance Treatment Of Airflow Obstruction In Patients With Chronic Obstructive Pulmonary Disease (Copd), Including Chronic Bronchitis And/or Emphysema. Important Limitations Of Use: Utibron Neohaler Is Not Indicated For The Relief Of Acute Bronchospasm Or For The Treatment Of Asthma [See Warnings And Precautions ( 5.1 , 5.2 )] . The Safety And Effectiveness Of Utibron In Asthma Have Not Been Established. Utibron Neohaler Is A Combination Of Indacaterol, A Long-Acting Beta 2 -Adrenergic Agonist (Laba), And Glycopyrrolate, An Anticholinergic, Indicated For The Long-Term, Maintenance Treatment Of Airflow Obstruction In 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 ( 2 Total)

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