Visitor Monitoring Drug History: SINGULAIR
 
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: SINGULAIR
FDA Application No: (NDA) 020829
Active Ingredient(s): MONTELUKAST SODIUM
Company: MERCK
 
Label History
 
View the label approved on December 14, 2006 for SINGULAIR, (NDA) 020829


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
4/13/2007 043Labeling Revision Letter 
4/13/2007 042Labeling Revision Letter 
4/13/2007 041Labeling Revision Letter 
12/8/2006 039Labeling Revision Letter
Label 
5/19/2006 038Labeling Revision Letter
Label 
6/27/2005 037Labeling Revision Letter
Label 
4/13/2007 036New or Modified Indication Letter
Label 
5/26/2005 035Labeling Revision Letter
Label 
11/30/2005 034Efficacy Supplement with Clinical Data to Support Letter
Label 
7/27/2005 033New or Modified Indication Letter
Label 
12/29/2004 032Labeling Revision Letter
Label 
11/15/2004 031Labeling Revision Letter
Label 
11/15/2004 029Labeling Revision  
12/19/2003 026Labeling Revision Letter
Label
Review 
11/5/2003 025Labeling Revision Letter
Label
Review 
10/2/2003 023Labeling Revision Letter
Label
Review 
10/7/2002 019Package Change  
7/11/2002 018Control Supplement  
12/31/2002 017New or Modified Indication Letter
Label 
2/11/2002 016Manufacturing Change or Addition  
10/26/2001 014Labeling Revision  
6/18/2001 013Control Supplement  
8/2/2001 012Labeling Revision Label 
9/5/2000 010Control Supplement  
10/17/2000 009Labeling Revision  
7/28/1999 007Control Supplement  
12/1/1998 006Labeling Revision  
1/21/1999 005Manufacturing Change or Addition  
9/18/1998 004Labeling Revision  
4/30/1998 003Labeling Revision  
4/2/1998 002Labeling Revision  
2/12/1999 001Labeling Revision Review 
2/20/1998 000Approval Letter
Label
Review
Consumer Information Sheet 
 
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