Application Nr Approved Date Route Status External Links
NDA021936 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Spiriva Respimat Is An Anticholinergic Indicated For: The Long-Term, Once-Daily, Maintenance Treatment Of Bronchospasm Associated With Chronic Obstructive Pulmonary Disease (Copd), And For Reducing Copd Exacerbations ( 1.1 ) The Long-Term, Once-Daily, Maintenance Treatment Of Asthma In Patients 6 Years Of Age And Older (1.2 ) Limitation Of Use: Not Indicated For Relief Of Acute Bronchospasm ( 1.1 , 1.2 , 5.1 ) 1.1 Maintenance Treatment Of Chronic Obstructive Pulmonary Disease Spiriva Respimat (Tiotropium Bromide) Is Indicated For The Long-Term, Once-Daily, Maintenance Treatment Of Bronchospasm Associated With Chronic Obstructive Pulmonary Disease (Copd), Including Chronic Bronchitis And Emphysema. Spiriva Respimat Is Indicated To Reduce Exacerbations In Copd Patients. Important Limitation Of Use: Spiriva Respimat Is Not Indicated For The Relief Of Acute Bronchospasm. 1.2 Maintenance Treatment Of Asthma Spiriva Respimat Is A Bronchodilator Indicated For The Long-Term, Once-Daily, Maintenance Treatment Of Asthma In Patients 6 Years Of Age And Older. Important Limitation Of Use: Spiriva Respimat Is Not Indicated For The Relief Of Acute Bronchospasm.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tiotropium Bromide TIOTROPIUM BROMIDE ZINC101144764

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