Drug Approval Package

 Boniva (Ibandronate Sodium) Injection
Company: Hoffmann-La Roche Inc.
Application No.:  021858
Approval Date: 01/06/2006

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s)
  Part 1
  Part 2

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: May 9, 2007

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