Drug Approval Package

Avelox (Moxifloxacin HCI) Tabelts
Company:  Bayer Corporation
Application No.:  21-334 & 21-085S10
Approval Date: 4/272001

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)

Date created: October 17, 2001

Back to Top    Drugs@FDA

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