Application Nr Approved Date Route Status External Links
ANDA202124 2014-06-24 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Paricalcitol Capsules Are A Vitamin D Analog Indicated For The Prevention And Treatment Of Secondary Hyperparathyroidism Associated With Chronic Kidney Disease (ckd) Stages 3 And 4 (1.1). Ckd Stage 5 In Patients On Hemodialysis (hd) Or Peritoneal Dialysis (pd) (1.2). Renal Osteodystrophy In Ckd Stage 5 Patients (with Prevention Of Hyperphosphatemia). 1.1 Chronic Kidney Disease Stages 3 And 4 Paricalictol Capsules Are Indicated For The Prevention And Treatment Of Secondary Hyperparathyroidism Associated With Chronic Kidney Disease (ckd) Stages 3 And 4. 1.2 Chronic Kidney Disease Stage 5 Paricalcitol Capsules Are Indicated For The Prevention And Treatment Of Secondary Hyperparathyroidism Associated With Ckd Stage 5 In Patients On Hemodialysis (hd) Or Peritoneal Dialysis (pd).

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Alcohol ALCOHOL Molecular
2. Butylated Hydroxytoluene BUTYLATED HYDROXYTOLUENE Molecular
3. Gelatin GELATIN Unresolved
4. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Polyvinyl Acetate Phthalate POLYVINYL ACETATE PHTHALATE Unresolved
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
8. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Paricalcitol PARICALCITOL ZINC13911941

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