Drug Approval Package

Hectorol (Doxercalciferol) Capsules
Company:  Bone Care International
Application No.:  020-862
Approval Date: 6/9/1999

• Approval Letter(s) & Final Printed Labeling (PDF) (1.1 MB)

• 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)

• 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)

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) (3 MB)

• Administrative Document(s)/Correspondence (PDF)

Date created: August 08, 2006

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