Drug Approval Package

Cipro (Ciprofloxacin Hydrochloride) Tablets, IV Solution, IV in 5% Dextrose, IV in 0.9% Saline, and Oral Suspension
Company:  Bayer Corporation
Application No.:  19-537/S38, 19-847/S24, 19-857/S27, 19-858/S21, & 20-780/S8
Approval Date: 8/30/2000

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)

• Medical Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

• Administrative Document(s) (PDF)  

• Correspondence (PDF)  

Date created: October 19, 2001

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