Drug Approval Package

Biaxin Filmtab (Clarithromycin) Tablets
Company:  Abbott Laboratories
Application No.:  50-662/S029
Approval Date: 10/20/2000

• Approval Letter(s)(PDF)  

• Printed Labeling(PDF)  

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

• Statistical Review(s)(PDF)  

• Microbiology Review(s)(PDF)

• Administrative Document(s)(PDF)

• Correspondence(PDF)

Date created: November 23, 2001

Back to Top    Drugs@FDA

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