Visitor Monitoring Drug History: AMARYL
 
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Label and Approval History

Drug Name: AMARYL
FDA Application No: (NDA) 020496
Active Ingredient(s): GLIMEPIRIDE
Company: SANOFI AVENTIS US
 
Label History
 
View the label approved on September 22, 2005 for AMARYL, (NDA) 020496


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
9/19/2005 016Labeling Revision Letter
Label 
11/28/2005 015Patient Population Altered Letter
Label 
8/16/2004 013Labeling Revision Letter 
7/21/2001 011Manufacturing Change or Addition  
12/5/2000 010Control Supplement  
8/29/2000 009Control Supplement  
4/15/2002 007Labeling Revision Letter 
1/6/2000 006Manufacturing Change or Addition  
9/27/2000 005Efficacy Supplement with Clinical Data to Support Review 
9/16/1998 004Package Change  
9/16/1998 003Package Change  
2/24/1999 002New or Modified Indication Letter
Review 
7/28/1997 001Manufacturing Change or Addition  
11/30/1995 000Approval  
 
Therapeutic Equivalents
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