Visitor Monitoring Drug History: SEREVENT
 
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Label and Approval History

Drug Name: SEREVENT
FDA Application No: (NDA) 020692
Active Ingredient(s): SALMETEROL XINAFOATE
Company: GLAXO GRP LTD
 
Label History
 
View the label approved on March 3, 2006 for SEREVENT, (NDA) 020692


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
3/2/2006 029Labeling Revision Letter
Label
Other Important Information from FDA 
2/23/2007 028Labeling Revision Letter
Label 
9/28/2004 026Labeling Revision Letter
Label 
8/11/2003 024Labeling Revision Letter
Label 
5/17/2002 020Control Supplement  
5/15/2002 018Manufacturing Change or Addition  
10/16/2001 017Control Supplement  
3/22/2002 016New or Modified Indication Letter
Label 
5/17/2001 015Labeling Revision  
6/15/2000 013Control Supplement  
4/3/2000 012Control Supplement  
6/29/2000 011Efficacy Supplement with Clinical Data to Support  
7/20/1999 010Manufacturing Change or Addition  
1/19/2001 009Control Supplement  
3/18/1998 008Control Supplement  
3/11/1998 007Labeling Revision  
12/3/1998 006Control Supplement  
3/18/1998 004Control Supplement  
3/26/1998 003Control Supplement  
9/25/1998 002Patient Population Altered Letter
Label
Review 
9/25/1998 001New or Modified Indication Letter
Label
Review 
9/19/1997 000Approval Review
Medication Guide
Other Important Information from FDA 
 
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