Visitor Monitoring Drug History: BIAXIN XL
 
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Label and Approval History

Drug Name: BIAXIN XL
FDA Application No: (NDA) 050775
Active Ingredient(s): CLARITHROMYCIN
Company: ABBOTT
 
Label History
 
View the label approved on October 10, 2005 for BIAXIN XL, (NDA) 050775


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
7/5/2006 009Labeling Revision Letter 
10/4/2005 008Labeling Revision Letter
Label 
7/19/2004 007Labeling Revision Letter 
12/20/2002 005Control Supplement  
4/11/2003 004Labeling Revision Letter
Review 
11/16/2001 003Package Change  
3/15/2002 002Labeling Revision  
8/2/2001 001New or Modified Indication Letter
Label
Review 
3/3/2000 000Approval Letter
Label
Review
Other Important Information from FDA 
 
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