Drug Approval Package

DuraPrep Surgical (Iodine Povacrylex (0.7% available iodine) and 74% w/w Isopropyl Alcohol) Solution
Company: 3M HealthCare
Application No.:  021586
Approval Date: 09/29/2006

• Approval Letter(s) (PDF) 
  

• Approvable Letter (PDF) 

• Office Director Memo (PDF) 

• Printed Labeling (PDF) 

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

• Chemistry Review(s) (PDF) 

• Pharmacology Review(s) (PDF) 

• Statistical Review(s) (PDF) 

• Microbiology Review(s) (PDF) 

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF) 

• Proprietary Name Review(s) (PDF) 

• Administrative Document(s) & Correspondence(PDF) 
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)

Date created: August 22, 2008

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