Drug Approval Package

 Cipro XR (Ciprofloxacin) Extended-Release Tablets
Company:  Bayer Corporation
Application No.:  021473
Approval Date: 12/13/2002

• Approval Letter(s) (PDF)

• Printed Labeling  

• Medical Review(s) (PDF)  

• 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: April 04, 2002

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