Tools / Drug approvals and letters / Drugs Montelukast Sodium Treats asthma. Sold as Singulair. Every FDA application for this active ingredient: 3 branded and 49 generic.
As of Nov 15, 2026, FDA lists 52 applications for Montelukast Sodium (sold as Singulair), first approved Feb 20, 1998, with 17 new uses approved and 0 published complete response letters.
First approved : Feb 20, 1998 Applications : 52 New uses approved : 17 Complete response letters : 0 Medicare spending, 2025 : $161M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Montelukast Sodium Part D $155M +14% 3,199,889 Singulair Part D $5.3M -8% 2,342
What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change SINGULAIR 10 MG TABLET: $9.23 per unit Brand · +5% in a year SINGULAIR 5 MG TABLET CHEW: $9.27 per unit Brand · +5% in a year FDA Drug Safety Communications One communication since 2020 that name this drug; see all communications
Shortages FDA's drug shortage list, as of Nov 13, 2026 Clinical Trials 2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Feb 20, 1998 Singulair NDA 20830 · New dosage form 54 Marketed Feb 20, 1998 Singulair NDA 20829 · New molecular entity 56 Marketed Jul 26, 2002 Singulair NDA 21409 · New dosage form 33 Discontinued Aug 3, 2012 Montelukast Sodium ANDA 78605 10 Marketed Aug 3, 2012 Montelukast Sodium ANDA 79142 9 Discontinued Aug 3, 2012 Montelukast Sodium ANDA 90655 6 Discontinued Aug 3, 2012 Montelukast Sodium ANDA 90926 6 Marketed Aug 3, 2012 Montelukast Sodium ANDA 201294 4 Discontinued Aug 3, 2012 Montelukast Sodium ANDA 201508 4 Discontinued Aug 3, 2012 Montelukast Sodium ANDA 202096 10 Marketed Aug 3, 2012 Montelukast Sodium ANDA 90984 10 Marketed Aug 3, 2012 Montelukast Sodium ANDA 91588 10 Discontinued Aug 3, 2012 Montelukast Sodium ANDA 200405 11 Marketed Aug 3, 2012 Montelukast Sodium ANDA 201515 9 Marketed Aug 3, 2012 Montelukast Sodium ANDA 201522 11 Marketed Aug 3, 2012 Montelukast Sodium ANDA 78723 11 Marketed Aug 3, 2012 Montelukast Sodium ANDA 79103 9 Discontinued Aug 3, 2012 Montelukast Sodium ANDA 90955 10 Discontinued Aug 3, 2012 Montelukast Sodium ANDA 91128 6 Discontinued Aug 3, 2012 Montelukast Sodium ANDA 91414 9 Discontinued Aug 3, 2012 Montelukast Sodium ANDA 91576 10 Discontinued Aug 3, 2012 Montelukast Sodium ANDA 200889 9 Marketed Aug 3, 2012 Montelukast Sodium ANDA 202468 10 Marketed Aug 6, 2012 Montelukast Sodium ANDA 201581 8 Marketed Aug 6, 2012 Montelukast Sodium ANDA 201582 11 Marketed Sep 17, 2012 Montelukast Sodium ANDA 202906 9 Marketed Sep 21, 2012 Montelukast Sodium ANDA 202717 11 Marketed Dec 18, 2012 Montelukast Sodium ANDA 202776 5 Discontinued Sep 10, 2014 Montelukast Sodium ANDA 202843 5 Marketed Sep 11, 2014 Montelukast Sodium ANDA 203366 8 Marketed Oct 30, 2014 Montelukast Sodium ANDA 202859 5 Marketed Oct 30, 2014 Montelukast Sodium ANDA 203037 4 Marketed Feb 27, 2015 Montelukast Sodium ANDA 203795 5 Discontinued Mar 12, 2015 Montelukast Sodium ANDA 203582 7 Marketed May 22, 2015 Montelukast Sodium ANDA 204093 5 Marketed Jul 31, 2015 Montelukast Sodium ANDA 203328 5 Discontinued Jul 31, 2015 Montelukast Sodium ANDA 203438 5 Marketed Jul 31, 2015 Montelukast Sodium ANDA 203432 5 Discontinued Sep 4, 2015 Montelukast Sodium ANDA 204604 6 Marketed Oct 8, 2015 Montelukast Sodium ANDA 204290 7 Marketed Nov 5, 2015 Montelukast Sodium ANDA 205695 2 Marketed Jan 12, 2016 Montelukast Sodium ANDA 205683 2 Marketed Oct 28, 2016 Montelukast Sodium ANDA 207463 5 Marketed Apr 18, 2017 Montelukast Sodium ANDA 209011 2 Marketed Apr 24, 2017 Montelukast Sodium ANDA 209012 2 Marketed Apr 26, 2017 Montelukast Sodium ANDA 206112 4 Discontinued Jul 2, 2018 Montelukast Sodium ANDA 208621 4 Marketed Jul 31, 2018 Montelukast Sodium ANDA 210431 5 Marketed Dec 6, 2018 Montelukast Sodium ANDA 207464 4 Marketed Feb 18, 2020 Montelukast Sodium ANDA 213471 2 Marketed Sep 4, 2020 Montelukast Sodium ANDA 205107 1 Discontinued Oct 30, 2020 Montelukast Sodium ANDA 205319 0 Discontinued
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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