Application Nr Approved Date Route Status External Links
NDA204096 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Astagraf Xl ® Is Indicated For The Prophylaxis Of Organ Rejection In Kidney Transplant Patients In Combination With Other Immunosuppressants In Adult And Pediatric Patients Who Can Swallow Capsules Intact [See Use In Specific Populations ( 8.4 ) And Clinical Studies ( 14.1 ), ( 14.2 )] . Astagraf Xl Is A Calcineurin-Inhibitor Immunosuppressant Indicated For The Prophylaxis Of Organ Rejection In Kidney Transplant Patients In Combination With Other Immunosuppressants In Adult And Pediatric Patients Who Can Swallow Capsules Intact. ( 1 , 8.4 , 14.1 , 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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