Sildenafil

Product manufactured by Proficient Rx Lp

Application Nr Approved Date Route Status External Links
ANDA203623 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Sildenafil Tablets Are Indicated For The Treatment Of Pulmonary Arterial Hypertension (who Group I) In Adults To Improve Exercise Ability And Delay Clinical Worsening. The Delay In Clinical Worsening Was Demonstrated When Sildenafil Tablets Were Added To Background Epoprostenol Therapy [see Clinical Studies (14) ] . Studies Establishing Effectiveness Were Short-Term (12 To 16 Weeks), And Included Predominately Patients With New York Heart Association (nyha) Functional Class Ii To Iii Symptoms And Idiopathic Etiology (71%) Or Associated With Connective Tissue Disease (ctd) (25%). Sildenafil Tablets Are A Phosphodiesterase-5 (pde-5) Inhibitor Indicated For The Treatment Of Pulmonary Arterial Hypertension (pah) (who Group I) In Adults To Improve Exercise Ability And Delay Clinical Worsening. Studies Establishing Effectiveness Were Short-Term (12 To 16 Weeks), And Included Predominately Patients With Nyha Functional Class Ii To Iii Symptoms. Etiologies Were Idiopathic (71%) Or Associated With Connective Tissue Disease (25%). ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Sildenafil Citrate SILDENAFIL CITRATE ZINC895081

Comments