Drug Approval Package

 Alinia (Nitazoxanide) Tablets & Oral Suspension
Company:  Romark Laboratories
Application No.:  021497 & 021498s001
Approval Date: 7/21/2004

• 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)  

• 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)  

Date created: September 302004

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