Drug Approval Package

Zemplar(Paricalcitol) Injection
Company:  Abbott Laboratories
Application No.:  20-819
Approval Date: 4/17/1998

• Approval Letter(s) (PDF)  

• Medical Review(s) (PDF)  

  Part 1 (PDF)
  Part 2 (PDF)
  Part 3 (PDF)
  Part 4 (PDF)
  Part 5 (PDF)

• Chemistry Review(s) (PDF)   

• Pharmacology Review(s)

  Part 1 (PDF)
  Part 2 (PDF)
  Part 3 (PDF)
  Part 4 (PDF)

• Statistical Review(s) (PDF)  
  Part 1 (PDF)  
  Part 2 (PDF)  

• Microbiology Review(s) (PDF)   

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)

Date created: September 10, 2001

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