Drug Approval Package
Hectorol
(doxercalciferol) Injection
Company: Bone Care International Inc.
Application No.: 021027
Approval Date: 4/6/00
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Approval Letter(s) and Printed Labeling(PDF) (2.9 MB)
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Medical Review(s)(PDF) (3 MB)
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Chemistry Review(s) and Statistical Review(s)(PDF) (2.3 MB)
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Microbiology Review(s) and Clinical Pharmacology Biopharmaceutics Review(s)(PDF) (1.8 MB)
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Administrative Document(s)(PDF) (2.9 MB)
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Correspondence
Part 1(PDF) (2.9 MB)
Part 2(PDF) (2.5 MB)
Part 3(PDF) (2.9 MB)
Part 4(PDF) (2.8 MB)
Date created: June 18, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.