Application Nr Approved Date Route Status External Links
NDA206756 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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