Visitor Monitoring Drug History: BIAXIN
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: BIAXIN
FDA Application No: (NDA) 050662
Active Ingredient(s): CLARITHROMYCIN
Company: ABBOTT
 
Label History
 
View the label approved on October 10, 2005 for BIAXIN, (NDA) 050662


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 039Labeling Revision Letter 
10/4/2005 038Labeling Revision Letter
Label 
7/19/2004 036Labeling Revision Letter 
11/8/2002 033Control Supplement  
6/6/2002 032Control Supplement  
6/6/2002 031Labeling Revision Letter
Review 
6/6/2002 030Labeling Revision Letter
Review 
10/20/2000 029New or Modified Indication Letter
Label
Review 
3/20/2000 028Labeling Revision Review 
5/4/1999 027Control Supplement  
7/29/1999 026Labeling Revision  
10/22/1999 025Formulation Revision  
11/10/1998 024Labeling Revision  
4/27/1998 023Formulation Revision  
7/21/1998 022Labeling Revision  
1/5/1998 021Package Change  
9/16/1998 020New or Modified Indication  
9/16/1997 019New or Modified Indication  
9/16/1997 018Labeling Revision  
4/29/1997 017Control Supplement  
1/14/1997 016Control Supplement  
1/16/1997 015New or Modified Indication  
10/15/1996 014Package Change  
12/20/1996 013Labeling Revision Review 
8/26/1997 012Labeling Revision  
8/31/1995 011Manufacturing Change or Addition  
4/18/1996 010New or Modified Indication  
3/13/1995 009Manufacturing Change or Addition  
12/23/1993 008Labeling Revision  
9/15/1993 007Manufacturing Change or Addition  
6/8/1993 005Manufacturing Change or Addition  
2/28/1995 004New or Modified Indication  
2/28/1995 003Labeling Revision  
1/28/1993 002Control Supplement  
6/17/1992 001Control Supplement  
10/31/1991 000Approval Other Important Information from FDA 
 
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