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) 020830
Active Ingredient(s): MONTELUKAST SODIUM
Company: MERCK
 
Label History
 
View the label approved on December 14, 2006 for SINGULAIR, (NDA) 020830


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 
12/8/2006 041Labeling Revision Letter
Label 
5/19/2006 040Labeling Revision Letter
Label 
6/27/2005 039Labeling Revision Letter
Label 
4/13/2007 038New or Modified Indication Letter
Label 
5/26/2005 037Labeling Revision Letter
Label 
11/30/2005 036Efficacy Supplement with Clinical Data to Support Letter
Label 
7/27/2005 035New or Modified Indication Letter
Label 
12/29/2004 034Labeling Revision Letter
Label 
11/15/2004 033Labeling Revision Letter
Label 
12/19/2003 029Labeling Revision Letter
Label
Review 
11/5/2003 028Labeling Revision Letter
Label
Review 
10/2/2003 026Labeling Revision Letter
Label
Review 
10/7/2002 021Package Change  
12/31/2002 020New or Modified Indication Letter
Label 
2/11/2002 019Manufacturing Change or Addition  
10/26/2001 016Labeling Revision  
5/9/2001 015Control Supplement  
8/2/2001 014Labeling Revision  
9/5/2000 012Control Supplement  
11/23/2001 011Efficacy Supplement with Clinical Data to Support Letter
Label 
10/17/2000 010Labeling Revision  
3/3/2000 008New or Modified Indication Letter
Label
Review 
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
Review
Consumer Information Sheet 
 
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