Visitor Monitoring Drug History: PAMELOR
 
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Label and Approval History

Drug Name: PAMELOR
FDA Application No: (NDA) 018013
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
Company: TYCO HLTHCARE
 
Label History
 
View the label approved on July 16, 2007 for PAMELOR, (NDA) 018013


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
7/13/2007 058Labeling Revision Letter
Label 
1/12/2005 056Labeling Revision Letter
Label 
12/6/2004 055Manufacturing Change or Addition  
6/7/2001 054Manufacturing Change or Addition  
7/31/2001 053Labeling Revision  
4/27/2000 052Manufacturing Change or Addition  
4/15/1999 051Package Change  
4/28/1999 050Manufacturing Change or Addition  
12/7/1995 048Manufacturing Change or Addition  
9/18/1995 047Control Supplement  
7/7/1994 044Control Supplement  
4/15/1994 043Manufacturing Change or Addition  
4/1/1994 042Package Change  
10/6/1993 041Labeling Revision  
7/23/1993 039Package Change  
8/17/1993 038Formulation Revision  
6/16/1993 037Control Supplement  
6/16/1993 036Control Supplement  
6/10/1993 035Control Supplement  
7/23/1993 034Control Supplement  
1/21/1992 033Manufacturing Change or Addition  
3/12/1992 032Package Change  
8/2/1991 031Control Supplement  
8/26/1993 030Labeling Revision  
3/13/1991 029Labeling Revision  
3/26/1990 026Manufacturing Change or Addition  
11/7/1989 023Package Change  
11/7/1988 021Package Change  
1/16/1990 020Package Change  
8/25/1986 019Control Supplement  
6/11/1985 016Labeling Revision  
6/27/1985 015Formulation Revision  
12/11/1984 014Package Change  
5/1/1984 012Labeling Revision  
6/2/1982 010Control Supplement  
3/25/1982 009Package Change  
6/26/1981 008Manufacturing Change or Addition  
7/24/1981 007Package Change  
11/20/1979 005Labeling Revision  
9/17/1979 004Package Change  
6/14/1979 003Manufacturing Change or Addition  
2/18/1982 002General Efficacy (MarkIV)  
6/29/1978 001General Efficacy (MarkIV)  
8/1/1977 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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