Sildenafil

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
ANDA203814 2013-12-17 Oral RX 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-Iii Symptoms And Idiopathic Etiology (71%) Or Associated With Connective Tissue Disease (ctd) (25%). Sildenafil Is 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-Iii Symptoms. Etiologies Were Idiopathic (71%) Or Associated With Connective Tissue Disease (25%). (1)

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Hypromelloses HYPROMELLOSES Unresolved

Active Ingredients ( 1 Total)

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

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