Drug Approval Package

 Tindamax (Tinidazole) Tablets
Company:  Presutti Laboratories, Inc.
Application No.:  021618, 021681 & 021682
Approval Date: 5/17/2004

• Approval Letter(s) (PDF)

• Printed Labeling (PDF)

• Medical Review(s)
  Part 1 (PDF)  
  Part 2 (PDF)  
  Part 3 (PDF)  
  Part 4 (PDF)  
  Part 5 (PDF)  

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)

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

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)

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

Date created: August 272004

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.