Application Nr Approved Date Route Status External Links
ANDA206693 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tadalafil Tablets, Usp Are 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 Tablets Are Used With Finasteride To Initiate Bph Treatment, Such Use Is Recommended For Up To 26 Weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil Tablets,usp Are Indicated For The Treatment Of Erectile Dysfunction (Ed). 1.2 Benign Prostatic Hyperplasia Tadalafil Tablets, Usp Are Indicated For The Treatment Of The Signs And Symptoms Of Benign Prostatic Hyperplasia (Bph). 1.3 Erectile Dysfunction And Benign Prostatic Hyperplasia Tadalafil Tablets, Usp Are Indicated For The Treatment Of Ed And The Signs And Symptoms Of Bph (Ed/bph). 1.4 Limitation Of Use If Tadalafil Tablets, Usp Are Used With Finasteride To Initiate Bph Treatment, Such Use Is Recommended For Up To 26 Weeks Because The Incremental Benefit Of Tadalafil Decreases From 4 Weeks Until 26 Weeks, And The Incremental Benefit Of Tadalafil 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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