Visitor Monitoring Drug History: FLAGYL I.V. RTU IN PLASTIC CONTAINER
 
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Label and Approval History

Drug Name: FLAGYL I.V. RTU IN PLASTIC CONTAINER
FDA Application No: (NDA) 018657
Active Ingredient(s): METRONIDAZOLE
Company: BAXTER HLTHCARE
 
Label History
 
View the label approved on June 7, 2004 for FLAGYL I.V. RTU IN PLASTIC CONTAINER, (NDA) 018657


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
6/2/2004 027Labeling Revision Letter
Label 
6/2/2004 026Labeling Revision Letter
Label 
1/30/1998 023Manufacturing Change or Addition  
5/13/1997 022Package Change  
4/16/1996 021Control Supplement  
2/28/1995 020Control Supplement  
9/21/1994 019Control Supplement  
8/9/1993 018Manufacturing Change or Addition  
5/15/1992 017Package Change  
4/2/1993 016Control Supplement  
11/8/1991 015Control Supplement  
9/25/1991 014Expiration Date Change  
7/2/1991 013Control Supplement  
4/13/1989 012Labeling Revision  
12/28/1987 011Labeling Revision  
8/26/1986 010Labeling Revision  
2/17/1988 009Labeling Revision  
4/24/1986 008Control Supplement  
2/17/1988 007Patient Population Altered  
2/17/1988 006Labeling Revision  
11/13/1984 005Control Supplement  
8/21/1987 004Labeling Revision  
8/8/1984 003Manufacturing Change or Addition  
12/20/1984 002Labeling Revision  
6/30/1982 001Labeling Revision  
12/24/1981 000Approval  
 
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