Drug Approval Package

Zithromax (Azithromycin) Capsules, Single Dose Packet & Tablets
Company:  Pfizer Inc.
Application No.:  50-670/S15, 50-693/S-003 & 50-730/S005
Approval Date: 11/13/00

• Approval Letter(s)(PDF)  

• Printed Labeling(PDF)  

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

• Chemistry 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: November 09, 2001

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