Drug Approval Package

Hectorol (doxercalciferol) Injection
Company:  Bone Care International Inc.
Application No.:  021027
Approval Date: 4/6/00

• Approval Letter(s) and Printed Labeling(PDF) (2.9 MB)

• Medical Review(s)(PDF) (3 MB)

• Chemistry Review(s) and Statistical Review(s)(PDF) (2.3 MB)

• Microbiology Review(s) and Clinical Pharmacology Biopharmaceutics Review(s)(PDF) (1.8 MB)

• Administrative Document(s)(PDF) (2.9 MB)

• 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

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