Drug Approval Package
Hectorol
(Doxercalciferol) Capsules
Company: Bone Care International
Application No.: 020-862
Approval Date: 6/9/1999
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Approval Letter(s) & Final Printed Labeling (PDF) (1.1 MB)
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Medical Review(s)
Part 1 (PDF) (2.8 MB)
Part 2 (PDF) (3 MB)
Part 3 (PDF) (2 MB)
Part 4 (PDF) (2.4 MB) -
Chemistry Review(s) (PDF) (262 KB)
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Pharmacology Review(s)
Part 1 (PDF) (3 MB)
Part 2 (PDF) (3 MB)
Part 3 (PDF) (2.3 MB)
Part 4 (PDF) (2.8 MB) -
Statistical Review(s) (PDF) (2.3 MB)
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Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (3 MB)
Date created: August 08, 2006
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