Drug Approval Package

 Pentetate Zinc Trisodium Injection & Pentetate Calcium Trisodium Injection
Company:  Hameln Pharmaceuticals
Application No.:  021749 & 021751
Approval Date: 8/11/2004

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

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

• Chemistry Review(s) (PDF)

• Pharmacology Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  

• Microbiology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  

Date created: October 202004

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