Visitor Monitoring Drug History: ZOLOFT
 
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Label and Approval History

Drug Name: ZOLOFT
FDA Application No: (NDA) 019839
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
Company: PFIZER
 
Label History
 
View the label approved on October 10, 2007 for ZOLOFT, (NDA) 019839


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
10/4/2007 065Labeling Revision Letter
Label 
8/2/2007 064Labeling Revision Letter
Label 
8/2/2007 063Labeling Revision Letter
Label 
9/14/2006 060Labeling Revision Letter
Label 
8/2/2007 059Labeling Revision Letter 
9/14/2006 058Labeling Revision Letter
Label 
5/4/2006 057Labeling Revision Letter 
7/26/2005 055Labeling Revision Letter 
2/18/2005 054Labeling Revision Letter
Label 
2/18/2005 053Labeling Revision Letter
Label 
8/19/2004 050Labeling Revision Letter
Label 
8/19/2004 047Efficacy Supplement with Clinical Data to Support Letter
Label 
2/7/2003 045New or Modified Indication Letter
Label 
9/16/2003 044Patient Population Altered Letter
Label
Review 
9/18/2002 043Labeling Revision Letter 
1/9/2002 042Manufacturing Change or Addition  
7/12/2001 040Manufacturing Change or Addition  
5/16/2002 039New or Modified Indication Letter
Label 
11/16/2000 038Labeling Revision  
2/22/2001 037Labeling Revision  
9/20/2002 036Efficacy Supplement with Clinical Data to Support Letter 
8/6/2001 035Efficacy Supplement with Clinical Data to Support Letter
Label
Review 
9/20/2002 034Efficacy Supplement with Clinical Data to Support  
10/12/2001 033Efficacy Supplement with Clinical Data to Support Letter
Label 
3/17/2000 032Manufacturing Change or Addition  
1/3/2000 031Package Change  
10/7/1999 030Manufacturing Change or Addition  
10/7/1999 029Manufacturing Change or Addition  
2/22/2001 027Labeling Revision  
12/7/1999 026New or Modified Indication Letter
Label
Review 
4/10/1998 024Control Supplement  
12/4/1997 023Control Supplement  
4/7/1997 020Control Supplement  
10/10/1997 018Labeling Revision Review 
10/10/1997 017Patient Population Altered Review 
3/5/1996 012Manufacturing Change or Addition  
7/8/1997 011New or Modified Indication Review 
3/6/1996 010Control Supplement  
10/5/1995 009Manufacturing Change or Addition  
6/16/1995 008Labeling Revision  
3/22/1995 007Control Supplement  
6/16/1995 006Labeling Revision  
9/7/1994 005Formulation Revision  
9/14/1995 003Labeling Revision  
10/25/1996 002New or Modified Indication  
6/22/1992 001Manufacturing Change or Addition  
12/30/1991 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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