Visitor Monitoring Drug History: FLAGYL ER
 
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Label and Approval History

Drug Name: FLAGYL ER
FDA Application No: (NDA) 020868
Active Ingredient(s): METRONIDAZOLE
Company: GD SEARLE LLC
 
Label History
 
View the label approved on April 5, 2004 for FLAGYL ER, (NDA) 020868


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
3/17/2004 006Labeling Revision Letter
Label 
4/23/2003 005Labeling Revision Letter
Label 
11/4/1998 004Package Change  
10/8/1998 003Labeling Revision  
7/24/1998 002Manufacturing Change or Addition  
2/20/1998 001Package Change  
11/26/1997 000Approval Review 
 
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