Treats asthma. NDA 21409, held by Organon. Montelukast Sodium.
As of Nov 14, 2026, NDA 21409 (Singulair), held by Organon, was first approved by FDA on Jul 26, 2002, with 33 approved supplements and 0 published complete response letters.
SINGULAIR is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12 months of age and older. Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies. Limitations of Use: Not indicated to treat an acute asthma attack. 1.
| Mar 26, 2012 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Apr 13, 2007 | Supplement 16Efficacy (new indication or use) | Approved | |
| Nov 30, 2005 | Supplement 14Efficacy (new indication or use) | Approved | |
| Jul 27, 2005 | Supplement 12Efficacy (new indication or use) | Approved | |
| Dec 31, 2002 | Supplement 3Efficacy (new indication or use) | Approved | |
| Jul 26, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| SingulairEQ 4MG BASE/PACKET · granule;oral | Montelukast Sodium | DiscontinuedReference drug |
| Feb 22, 2021 | Supplement 52Labeling · Standard review | Approved | |
| Apr 29, 2020 | Supplement 51Labeling · Standard review | Approved | |
| Aug 9, 2019 | Supplement 50Labeling · Standard review | Approved | |
| Dec 21, 2018 | Supplement 49Labeling · Standard review | Approved | |
| Dec 21, 2018 | Supplement 48Labeling · Standard review | Approved | |
| Dec 13, 2016 | Supplement 47Labeling · Standard review | Approved | |
| Nov 26, 2014 | Supplement 45Labeling · Standard review | Approved | |
| Dec 30, 2013 | Supplement 43Labeling · Standard review | Approved | |
| Mar 21, 2013 | Supplement 42Labeling · Standard review | Approved | |
| Oct 18, 2012 | Supplement 39Labeling | Approved | |
| Sep 27, 2012 | Supplement 40Labeling | Approved | |
| Mar 26, 2012 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Dec 16, 2011 | Supplement 37Labeling | Approved | |
| Apr 27, 2011 | Supplement 34Labeling | Approved | |
| Aug 10, 2010 | Supplement 31Labeling | Approved | |
| Apr 26, 2010 | Supplement 29Labeling · Standard review | Approved | |
| Aug 19, 2009 | Supplement 28Labeling · Standard review | Approved | |
| Jan 27, 2009 | Supplement 27Labeling · Standard review | Approved | |
| Apr 24, 2008 | Supplement 26Labeling · Standard review | Approved | |
| Apr 21, 2008 | Supplement 25Labeling · Standard review | Approved | |
| Mar 7, 2008 | Supplement 23Labeling · Standard review | Approved | |
| Apr 13, 2007 | Supplement 16Efficacy (new indication or use) | Approved | |
| Dec 8, 2006 | Supplement 19Labeling · Standard review | Approved | |
| May 19, 2006 | Supplement 18Labeling · Standard review | Approved | |
| Nov 30, 2005 | Supplement 14Efficacy (new indication or use) | Approved | |
| Jul 27, 2005 | Supplement 12Efficacy (new indication or use) | Approved | |
| Jun 27, 2005 | Supplement 17Labeling · Standard review | Approved | |
| May 26, 2005 | Supplement 15Labeling · Standard review | Approved | |
| Dec 29, 2004 | Supplement 11Labeling · Standard review | Approved | None posted |
| Nov 15, 2004 | Supplement 10Labeling · Standard review | Approved | |
| Dec 19, 2003 | Supplement 7Labeling · Standard review | Approved | |
| Oct 2, 2003 | Supplement 5Labeling · Standard review | Approved | |
| Dec 31, 2002 | Supplement 3Efficacy (new indication or use) | Approved | |
| Jul 26, 2002 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
