Visitor Monitoring Drug History: ISMELIN
 
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Label and Approval History

Drug Name: ISMELIN
FDA Application No: (NDA) 012329
Active Ingredient(s): GUANETHIDINE MONOSULFATE
Company: NOVARTIS
 
Label History
 
Labels are not available on this site for ISMELIN, (NDA) 012329
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/22/1986 054Labeling Revision  
5/5/1986 053Labeling Revision  
5/5/1986 052Labeling Revision  
3/19/1985 051Control Supplement  
5/5/1986 050Practioner Draft Labeling  
2/2/1981 049Formulation Revision  
12/12/1980 048Labeling Revision  
5/8/1980 047Labeling Revision  
1/24/1980 046Package Change  
1/17/1980 045Package Change  
6/25/1979 044Package Change  
6/25/1979 043Package Change  
6/25/1979 042Package Change  
1/8/1979 041Labeling Revision  
1/31/1979 040Control Supplement  
2/12/1979 039Package Change  
6/29/1977 038Control Supplement  
4/12/1977 037Manufacturing Change or Addition  
12/2/1976 036Package Change  
12/29/1976 035Control Supplement  
2/3/1976 034Manufacturing Change or Addition  
3/19/1976 033Control Supplement  
7/2/1975 032Control Supplement  
3/31/1975 030Control Supplement  
3/31/1975 029Package Change  
3/31/1975 028Package Change  
5/15/1975 026Other Amendment  
5/15/1975 023Other Amendment  
7/5/1960 000Approval  
 
Therapeutic Equivalents
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