Visitor Monitoring Drug History: ISONIAZID
 
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Label and Approval History

Drug Name: ISONIAZID
FDA Application No: (NDA) 008678
Active Ingredient(s): ISONIAZID
Company: SANDOZ
 
Label History
 
Labels are not available on this site for ISONIAZID, (NDA) 008678
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/23/2007 026Labeling Revision Letter 
4/23/2007 025Labeling Revision Letter 
7/13/2000 023Manufacturing Change or Addition  
2/7/2000 022Manufacturing Change or Addition  
3/6/1997 021Labeling Revision  
11/21/1995 020Package Change  
8/1/1996 019Labeling Revision  
8/10/1992 018Manufacturing Change or Addition  
8/10/1992 017Manufacturing Change or Addition  
9/23/1988 016Manufacturing Change or Addition  
5/9/1985 015Manufacturing Change or Addition  
9/10/1987 014Labeling Revision  
1/4/1984 012Control Supplement  
8/19/1983 011Control Supplement  
8/19/1983 010Control Supplement  
3/28/1983 009Control Supplement  
3/28/1983 008Control Supplement  
9/30/1980 007Control Supplement  
11/17/1952 000Approval  
 
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