Application Nr Approved Date Route Status External Links
ANDA078396 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Epoprostenol Sodium For Injection Is Indicated For The Treatment Of Pulmonary Arterial Hypertension (Pah) (Who Group I) To Improve Exercise Capacity. Trials Establishing Effectiveness Included Predominantly (97%) Patients With New York Heart Association (Nyha) Functional Class Iii-Iv Symptoms And Etiologies Of Idiopathic Or Heritable Pah (49%) Or Pah Associated With Connective Tissue Diseases (51%). Epoprostenol Sodium For Injection Is A Prostacyclin Vasodilator Indicated For The Treatment Of Pulmonary Arterial Hypertension (Pah) (Who Group I) To Improve Exercise Capacity. Studies Establishing Effectiveness Included Predominantly (97%) Patients With Nyha Functional Class Iii-Iv Symptoms And Etiologies Of Idiopathic Or Heritable Pah (49%) Or Pah Associated With Connective Tissue Diseases (51%). ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Epoprostenol Sodium EPOPROSTENOL SODIUM ZINC3813078

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