Visitor Monitoring Drug History: ELAVIL
 
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Label and Approval History

Drug Name: ELAVIL
FDA Application No: (NDA) 012704
Active Ingredient(s): AMITRIPTYLINE HYDROCHLORIDE
Company: ASTRAZENECA
 
Label History
 
Labels are not available on this site for ELAVIL, (NDA) 012704
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
7/29/2003 046Labeling Revision Letter 
3/27/2001 045Labeling Revision Letter 
4/5/2000 044Labeling Revision  
12/24/1998 043Manufacturing Change or Addition  
4/5/2000 042Labeling Revision  
4/5/2000 041Labeling Revision  
4/5/2000 040Labeling Revision  
4/5/2000 039Labeling Revision  
7/28/1989 036Manufacturing Change or Addition  
6/24/1991 035Labeling Revision  
12/12/1988 034Formulation Revision  
6/24/1991 033Labeling Revision  
7/10/1986 032Labeling Revision  
9/20/1985 031Labeling Revision  
3/15/1983 030Labeling Revision  
5/21/1984 028Labeling Revision  
10/2/1995 026Manufacturing Change or Addition  
6/25/1981 025Manufacturing Change or Addition  
3/23/1981 024Labeling Revision  
9/3/1980 023Labeling Revision  
6/23/1980 022Labeling Revision  
3/2/1981 021Manufacturing Change or Addition  
3/4/1980 019Labeling Revision  
3/2/1981 017Manufacturing Change or Addition  
3/9/1981 013Control Supplement  
4/11/1961 000Approval Other Important Information from FDA 
 
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