Visitor Monitoring Drug History: AMOXIL
 
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Label and Approval History

Drug Name: AMOXIL
FDA Application No: (NDA) 050542
Active Ingredient(s): AMOXICILLIN
Company: GLAXOSMITHKLINE
 
Label History
 
Labels are not available on this site for AMOXIL, (NDA) 050542
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/26/2006 023Labeling Revision  
7/13/2004 022Labeling Revision Letter 
12/18/2003 021Labeling Revision Letter 
12/4/2002 020Control Supplement  
5/12/2003 019Labeling Revision Letter 
4/17/2001 018Control Supplement  
5/16/2000 017Labeling Revision Review 
4/10/2002 016Labeling Revision Letter
Review 
2/12/1998 012Manufacturing Change or Addition  
2/27/1998 011New or Modified Indication Review 
2/27/1998 010Labeling Revision Review 
1/10/1995 008Labeling Revision  
9/13/1993 007Labeling Revision  
4/10/1991 006Labeling Revision  
2/27/1998 005Labeling Revision Review 
4/23/1991 004Control Supplement  
2/8/1989 003Formulation Revision  
9/12/1988 002Labeling Revision  
12/17/1985 001Labeling Revision  
10/21/1980 000Approval  
 
Therapeutic Equivalents
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