Application Nr Approved Date Route Status External Links
ANDA209908 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Tadalafil Is A Phosphodiesterase 5 (pde5) Inhibitor Indicated For The Treatment Of: • Erectile Dysfunction (ed) ( 1.1 ) • The Signs And Symptoms Of Benign Prostatic Hyperplasia (bph) ( 1.2 ) • Ed And The Signs And Symptoms Of Bph (ed/bph) ( 1.3 ) If Tadalafil Tablet Is Used With Finasteride To Initiate Bph Treatment, Such Use Is Recommended For Up To 26 Weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil Tablet Is Indicated For The Treatment Of Erectile Dysfunction (ed). 1.2 Benign Prostatic Hyperplasia Tadalafil Tablet Is Indicated For The Treatment Of The Signs And Symptoms Of Benign Prostatic Hyperplasia (bph). 1.3 Erectile Dysfunction And Benign Prostatic Hyperplasia Tadalafil Tablet Is Indicated For The Treatment Of Ed And The Signs And Symptoms Of Bph (ed/bph). 1.4 Limitation Of Use If Tadalafil Tablet Is Used With Finasteride To Initiate Bph Treatment, Such Use Is Recommended For Up To 26 Weeks Because The Incremental Benefit Of Tadalafil Tablets Decreases From 4 Weeks Until 26 Weeks, And The Incremental Benefit Of Tadalafil Tablets Beyond 26 Weeks Is Unknown [see Clinical Studies ( 14.3 )].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tadalafil TADALAFIL ZINC3993855

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