Application Nr Approved Date Route Status External Links
NDA208010 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Rayaldee Is A Vitamin D 3 Analog Indicated For The Treatment Of Secondary Hyperparathyroidism In Adult Patients With Stage 3 Or 4 Chronic Kidney Disease And Serum Total 25-Hydroxyvitamin D Levels Less Than 30 Ng/ml. Limitations Of Use Rayaldee Is Not Indicated For The Treatment Of Secondary Hyperparathyroidism In Patients With Stage 5 Chronic Kidney Disease Or In Patients With End-Stage Renal Disease On Dialysis. Rayaldee Is A Vitamin D 3 Analog Indicated For The Treatment Of Secondary Hyperparathyroidism In Adults With Stage 3 Or 4 Chronic Kidney Disease And Serum Total 25-Hydroxyvitamin D Levels Less Than 30 Ng/ml. ( 1 ) Limitations Of Use: Rayaldee Is Not Indicated In Patients With Stage 5 Chronic Kidney Disease Or End-Stage Renal Disease On Dialysis. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Calcifediol CALCIFEDIOL ZINC12484926

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