Visitor Monitoring Drug History: BIAXIN
 
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Label and Approval History

Drug Name: BIAXIN
FDA Application No: (NDA) 050698
Active Ingredient(s): CLARITHROMYCIN
Company: ABBOTT
 
Label History
 
View the label approved on October 10, 2005 for BIAXIN, (NDA) 050698


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 021Labeling Revision Letter 
10/4/2005 020Labeling Revision Letter
Label 
7/19/2004 019Labeling Revision Letter 
11/21/2002 015Control Supplement  
5/24/2002 014Accelerated Approval Letter 
6/5/2000 011Labeling Revision  
9/30/1998 010Control Supplement  
10/3/1997 008Control Supplement  
8/26/1997 007Labeling Revision  
10/23/1995 006Formulation Revision  
3/24/1994 005Control Supplement  
8/12/1994 004New or Modified Indication  
8/12/1994 003New or Modified Indication  
8/12/1994 002New or Modified Indication  
7/17/1996 001New or Modified Indication  
12/23/1993 000Approval Other Important Information from FDA 
 
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