Application Nr Approved Date Route Status External Links
NDA203108 None Respiratory (Inhalation) None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Striverdi Respimat Inhalation Spray Is A Long-Acting Beta 2 -Adrenergic Agonist (Laba) 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: Striverdi Respimat Is Not Indicated To Treat Acute Deterioration Of Copd ( 1.2 ) Striverdi Respimat Is Not Indicated To Treat Asthma ( 1.2 ) 1.1 Maintenance Treatment Of Copd Striverdi Respimat 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 Striverdi Respimat Is Not Indicated To Treat Acute Deteriorations Of Copd [ See Warnings And Precautions ( 5.2 ) ]. Striverdi Respimat Is Not Indicated To Treat Asthma. The Safety And Effectiveness Of Striverdi Respimat In Asthma Have Not Been Established.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Olodaterol Hydrochloride OLODATEROL HYDROCHLORIDE ZINC34636383

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