Application Nr Approved Date Route Status External Links
NDA206406 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Envarsus Xr Is A Calcineurin-Inhibitor Immunosuppressant Indicated For: The Prophylaxis Of Organ Rejection In De Novo Kidney Transplant Patients In Combination With Other Immunosuppressants ( 1.1 ) The Prophylaxis Of Organ Rejection In Kidney Transplant Patients Converted From Tacrolimus Immediate-Release Formulations In Combination With Other Immunosuppressants ( 1.2 ) 1.1 Prophylaxis Of Organ Rejection In De Novo Kidney Transplant Patients Envarsus Xr Is Indicated For The Prophylaxis Of Organ Rejection In Kidney Transplant Patients In Combination With Other Immunosuppressants [See Clinical Studies (14.1) ]. 1.2 Prophylaxis Of Organ Rejection In Stable Kidney Transplant Patients Converting From Immediate-Release Formulations Envarsus Xr Is Indicated For The Prophylaxis Of Organ Rejection In Kidney Transplant Patients Converted From Tacrolimus Immediate-Release Formulations, In Combination With Other Immunosuppressants [See Clinical Studies (14.2) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tacrolimus TACROLIMUS ZINC85537027

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