Treats asthma. NDA 20830, held by Organon. Montelukast Sodium.
As of Nov 13, 2026, NDA 20830 (Singulair), held by Organon, was first approved by FDA on Feb 20, 1998, with 54 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 61Efficacy (new indication or use) · Standard review | Approved | |
| Apr 13, 2007 | Supplement 38Efficacy (new indication or use) | Approved | |
| Nov 30, 2005 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Jul 27, 2005 | Supplement 35Efficacy (new indication or use) | Approved | |
| Dec 31, 2002 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Nov 23, 2001 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Mar 3, 2000 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Feb 20, 1998 | Original applicationNew dosage form · Standard review | Approved |
| SingulairEQ 5MG BASE · tablet, chewable;oral | Montelukast Sodium | RxReference drug |
| SingulairEQ 4MG BASE · tablet, chewable;oral | Montelukast Sodium | DiscontinuedReference drug |
| Feb 22, 2021 | Supplement 76Labeling · Standard review | Approved | |
| Apr 29, 2020 | Supplement 75Labeling · Standard review | Approved | |
| Aug 9, 2019 | Supplement 74Labeling · Standard review | Approved | |
| Dec 21, 2018 | Supplement 73Labeling · Standard review | Approved | |
| Dec 21, 2018 | Supplement 72Labeling · Standard review | Approved | |
| Dec 13, 2016 | Supplement 71Labeling · Standard review | Approved | |
| Nov 26, 2014 | Supplement 70Labeling · Standard review | Approved | |
| Oct 29, 2014 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Dec 30, 2013 | Supplement 68Labeling · Standard review | Approved | |
| Mar 21, 2013 | Supplement 66Labeling · Standard review | Approved | |
| Oct 18, 2012 | Supplement 63Labeling | Approved | |
| Sep 27, 2012 | Supplement 64Labeling | Approved | |
| Mar 26, 2012 | Supplement 61Efficacy (new indication or use) · Standard review | Approved | |
| Dec 16, 2011 | Supplement 62Labeling | Approved | |
| Jun 10, 2011 | Supplement 55Labeling | Approved | |
| Apr 27, 2011 | Supplement 59Labeling | Approved | |
| Aug 10, 2010 | Supplement 56Labeling | Approved | |
| Apr 26, 2010 | Supplement 53Labeling · Standard review | Approved | |
| Aug 19, 2009 | Supplement 52Labeling · Standard review | Approved | |
| Jan 27, 2009 | Supplement 51Labeling · Standard review | Approved | |
| Apr 24, 2008 | Supplement 50Labeling · Standard review | Approved | |
| Apr 21, 2008 | Supplement 49Labeling · Standard review | Approved | |
| Mar 7, 2008 | Supplement 48Labeling · Standard review | Approved | |
| Dec 7, 2007 | Supplement 47Labeling · Standard review | Approved | |
| Apr 13, 2007 | Supplement 43Labeling · Standard review | Approved | |
| Apr 13, 2007 | Supplement 38Efficacy (new indication or use) | Approved | |
| Dec 8, 2006 | Supplement 41Labeling · Standard review | Approved | |
| May 19, 2006 | Supplement 40Labeling · Standard review | Approved | |
| Nov 30, 2005 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Jul 27, 2005 | Supplement 35Efficacy (new indication or use) | Approved | |
| Jun 27, 2005 | Supplement 39Labeling · Standard review | Approved | |
| May 26, 2005 | Supplement 37Labeling · Standard review | Approved | |
| Dec 29, 2004 | Supplement 34Labeling · Standard review | Approved | |
| Nov 15, 2004 | Supplement 33Labeling · Standard review | Approved | |
| Dec 19, 2003 | Supplement 29Labeling · Standard review | Approved | |
| Nov 5, 2003 | Supplement 28Labeling · Standard review | Approved | |
| Oct 2, 2003 | Supplement 26Labeling · Standard review | Approved | |
| Dec 31, 2002 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Oct 7, 2002 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Feb 11, 2002 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Nov 23, 2001 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Oct 26, 2001 | Supplement 16Labeling · Standard review | Approved | None posted |
| Aug 2, 2001 | Supplement 14Labeling · Standard review | Approved | None posted |
| May 9, 2001 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Oct 17, 2000 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 5, 2000 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 3, 2000 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 1999 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Feb 12, 1999 | Supplement 1Labeling · Standard review | Approved | |
| Jan 21, 1999 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Dec 1, 1998 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 18, 1998 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 30, 1998 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 2, 1998 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 20, 1998 | 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
