Drug Approval Package

Avelox (Moxifloxacin Hydrochloride) Tablets
Company:  Bayer Corporation
Application No.:  21-085
Approval Date: 12/10/1999

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s)

  Part 1 (PDF)
  Part 2 (PDF)
  Part 3 (PDF)
  Part 4 (PDF)
  Part 5 (PDF)
  Part 6 (PDF)
  Part 7 (PDF)
  Part 8 (PDF)

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s)

  Part 1 (PDF)
  Part 2 (PDF)

• Statistical Review(s) (PDF)  

• Microbiology Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)

Date created: July 18, 2001

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.