Visitor Monitoring Drug History: FLAGYL I.V.
 
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Label and Approval History

Drug Name: FLAGYL I.V.
FDA Application No: (NDA) 018353
Active Ingredient(s): METRONIDAZOLE HYDROCHLORIDE
Company: GD SEARLE LLC
 
Label History
 
Labels are not available on this site for FLAGYL I.V., (NDA) 018353
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
3/5/1993 025Manufacturing Change or Addition  
11/30/1992 024Labeling Revision  
4/13/1989 023Labeling Revision  
2/17/1988 022Labeling Revision  
9/9/1986 021Manufacturing Change or Addition  
9/2/1986 020Labeling Revision  
4/24/1986 018Package Change  
6/20/1986 017Manufacturing Change or Addition  
2/17/1988 016Labeling Revision  
2/17/1988 015Patient Population Altered  
2/17/1988 014Labeling Revision  
10/29/1987 013Package Change  
8/21/1987 011Manufacturing Change or Addition  
12/14/1983 010Labeling Revision  
12/2/1982 009Expiration Date Change  
9/15/1982 008Manufacturing Change or Addition  
6/30/1982 007Labeling Revision  
1/11/1982 006Control Supplement  
11/2/1981 005Manufacturing Change or Addition  
11/25/1981 003Manufacturing Change or Addition  
12/20/1984 002Labeling Revision  
5/29/1981 001Control Supplement  
11/28/1980 000Approval  
 
Therapeutic Equivalents
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