Visitor Monitoring Drug History: SEREVENT
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: SEREVENT
FDA Application No: (NDA) 020236
Active Ingredient(s): SALMETEROL XINAFOATE
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on October 4, 2004 for SEREVENT, (NDA) 020236


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
9/28/2004 030Labeling Revision Letter
Label 
8/11/2003 028Labeling Revision Letter
Label 
10/16/2001 025Control Supplement  
5/17/2001 023Labeling Revision  
6/15/2000 021Control Supplement  
6/29/2000 019Efficacy Supplement with Clinical Data to Support  
2/25/2000 018Labeling Revision  
12/24/1998 017Labeling Revision Review 
5/11/1998 016Labeling Revision  
2/5/1998 015New or Modified Indication  
11/26/1997 014Labeling Revision  
8/6/1996 013Manufacturing Change or Addition  
11/13/1995 011Control Supplement  
7/19/1995 010Control Supplement  
12/23/1994 009Labeling Revision  
3/14/1995 008Control Supplement  
12/23/1994 006Control Supplement  
10/15/1996 003Control Supplement  
7/9/1996 001Labeling Revision  
2/4/1994 000Approval Other Important Information from FDA 
 
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