Visitor Monitoring Drug History: PENTAM
 
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Label and Approval History

Drug Name: PENTAM
FDA Application No: (NDA) 019264
Active Ingredient(s): PENTAMIDINE ISETHIONATE
Company: ABRAXIS PHARM
 
Label History
 
Labels are not available on this site for PENTAM, (NDA) 019264
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
5/24/2002 023Manufacturing Change or Addition  
10/24/1997 021Labeling Revision  
2/26/1997 019Labeling Revision  
3/18/1996 018Labeling Revision  
6/8/1994 017Control Supplement  
5/31/1994 016Control Supplement  
8/27/1996 015Labeling Revision  
8/16/1989 014Manufacturing Change or Addition  
2/9/1993 013Labeling Revision  
11/14/1988 012Package Change  
6/12/1987 008Control Supplement  
10/24/1986 007Manufacturing Change or Addition  
10/24/1986 006Manufacturing Change or Addition  
10/24/1986 005Manufacturing Change or Addition  
4/9/1987 004Labeling Revision  
6/10/1987 003Control Supplement  
8/6/1985 002Control Supplement  
10/16/1984 000Approval  
 
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