Visitor Monitoring Drug History: SERZONE
 
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Label and Approval History

Drug Name: SERZONE
FDA Application No: (NDA) 020152
Active Ingredient(s): NEFAZODONE HYDROCHLORIDE
Company: BRISTOL MYERS SQUIBB
 
Label History
 
View the label approved on January 13, 2005 for SERZONE, (NDA) 020152


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
1/12/2005 035Labeling Revision Letter
Label 
5/27/2004 034Labeling Revision Letter 
6/20/2002 033Labeling Revision Letter 
5/5/2003 031Labeling Revision Letter
Review 
4/23/2002 030Manufacturing Change or Addition  
1/8/2002 029Labeling Revision Letter 
12/4/2001 028Labeling Revision Letter
Review 
3/11/2002 027Control Supplement  
3/21/2001 026Labeling Revision Letter
Review 
1/23/2001 025Labeling Revision  
11/9/2000 024Manufacturing Change or Addition  
6/1/2000 023Labeling Revision  
4/10/2000 022Manufacturing Change or Addition  
11/30/1999 021Control Supplement  
9/9/1999 020Labeling Revision  
6/1/2000 019Labeling Revision  
9/23/1999 018Manufacturing Change or Addition  
6/1/2000 017Labeling Revision  
6/1/2000 016Labeling Revision  
6/1/2000 015Labeling Revision  
1/27/1999 013Manufacturing Change or Addition  
8/6/1997 012Labeling Revision  
3/31/1998 011Labeling Revision Letter 
5/5/1997 010Labeling Revision Review 
5/5/1997 009Labeling Revision Review 
12/2/1996 008Manufacturing Change or Addition  
1/13/1997 007Control Supplement  
7/26/2000 006Labeling Revision Review 
2/6/1997 005Manufacturing Change or Addition  
3/28/1996 004Manufacturing Change or Addition  
6/25/1996 003Labeling Revision  
3/20/1996 002Manufacturing Change or Addition  
3/28/1996 001Manufacturing Change or Addition  
12/22/1994 000Approval Other Important Information from FDA 
 
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