Drug Approval Package

Cipro (Ciprofloxacin Hydrochloride) Tablets, Cipro IV (Ciprofloxacin) Solution, Cipro (Ciprofloxacin) Oral Suspension
Company: Bayer Pharmaceuticals Corporation
Application No.:  019537s049, 019847s027, 019857s031 & 020780s013
Approval Date: 03/25/2004

• Approval Letter(s) (PDF) 
  

• Office Director Memo (PDF) 

• Printed Labeling (PDF) 

• Medical Review(s) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)
  Part 4 (PDF)  

• Chemistry Review(s) (PDF) 

• Pharmacology Review(s) (PDF) 

• Statistical Review(s) (PDF) 

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

• Administrative Document(s) & Correspondence (PDF) 

Date created: October 1, 2008

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