Application Nr Approved Date Route Status External Links
NDA022522 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Daliresp ® Is Indicated As A Treatment To Reduce The Risk Of Copd Exacerbations In Patients With Severe Copd Associated With Chronic Bronchitis And A History Of Exacerbations. Daliresp Is A Selective Phosphodiesterase 4 Inhibitor Indicated As A Treatment To Reduce The Risk Of Copd Exacerbations In Patients With Severe Copd Associated With Chronic Bronchitis And A History Of Exacerbations. ( 1 , 14 ) Limitations Of Use : • Daliresp Is Not A Bronchodilator And Is Not Indicated For The Relief Of Acute Bronchospasm. ( 1, 14 ) • Daliresp 250 Mcg Is A Starting Dose, For The First 4 Weeks Of Treatment Only And Is Not The Effective (Therapeutic) Dose. ( 2, 14 ) Limitations Of Use Daliresp Is Not A Bronchodilator And Is Not Indicated For The Relief Of Acute Bronchospasm. Daliresp 250 Mcg Is A Starting Dose, For The First 4 Weeks Of Treatment Only And Is Not The Effective (Therapeutic) Dose.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Roflumilast ROFLUMILAST ZINC592419

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