Visitor Monitoring Drug History: SUBLIMAZE PRESERVATIVE FREE
 
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Label and Approval History

Drug Name: SUBLIMAZE PRESERVATIVE FREE
FDA Application No: (NDA) 016619
Active Ingredient(s): FENTANYL CITRATE
Company: AKORN MFG
 
Label History
 
Labels are not available on this site for SUBLIMAZE PRESERVATIVE FREE, (NDA) 016619
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
10/17/2003 032Labeling Revision Letter 
4/26/1996 031Labeling Revision  
2/22/1995 030Manufacturing Change or Addition  
12/23/1993 029Labeling Revision  
12/23/1993 028Package Change  
12/23/1993 027Manufacturing Change or Addition  
12/23/1993 026Control Supplement  
10/28/1992 025Manufacturing Change or Addition  
12/7/1992 024Control Supplement  
7/5/1990 023Control Supplement  
9/14/1989 022Manufacturing Change or Addition  
11/25/1991 021Control Supplement  
1/27/1987 020Labeling Revision  
9/5/1986 019Labeling Revision  
9/5/1986 018Control Supplement  
9/10/1985 017Practioner Draft Labeling  
9/7/1983 014Control Supplement  
3/11/1983 013Manufacturing Change or Addition  
7/7/1982 012Labeling Revision  
7/7/1982 011Control Supplement  
2/24/1981 010Labeling Revision  
2/24/1981 009Control Supplement  
5/23/1980 006Control Supplement  
11/8/1976 004Labeling Revision  
2/19/1968 000Approval  
 
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