Treats asthma. NDA 22518, held by Organon LLC. Formoterol Fumarate; Mometasone Furoate.
As of Nov 14, 2026, NDA 22518 (Dulera), held by Organon LLC, was first approved by FDA on Jun 22, 2010, with 24 approved supplements and 0 published complete response letters.
DULERA is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: Treatment of asthma in patients 5 years of age and older. Important Limitation of Use: Not indicated for the relief of acute bronchospasm. 1.1 Treatment of Asthma DULERA is indicated for the twice-daily treatment of asthma in patients 5 years of age and older. DULERA should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an ICS and long-acting beta 2 -adrenergic agonist (LABA).
| Aug 12, 2019 | Supplement 26Efficacy (new indication or use) · Priority review | Approved | |
| Dec 20, 2017 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Jul 12, 2016 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Jun 22, 2010 | Original applicationNew combination · Standard review | Approved |
| Dulera0.005MG/INH;0.1MG/INH · aerosol, metered;inhalation | Formoterol Fumarate; Mometasone Furoate | RxReference drug |
| Dulera0.005MG/INH;0.2MG/INH · aerosol, metered;inhalation | Formoterol Fumarate; Mometasone Furoate | RxReference drug |
| Dulera0.005MG/INH;0.05MG/INH · aerosol, metered;inhalation | Formoterol Fumarate; Mometasone Furoate | RxReference drug |
| Jun 5, 2025 | Supplement 33Manufacturing | Approved | |
| Aug 12, 2019 | Supplement 26Efficacy (new indication or use) · Priority review | Approved | |
| Mar 23, 2018 | Supplement 24Labeling · Standard review | Approved | |
| Mar 23, 2018 | Supplement 23Labeling · Standard review | Approved | |
| Dec 20, 2017 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Jun 27, 2017 | Supplement 21Labeling · Standard review | Approved | |
| Jul 12, 2016 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| May 12, 2016 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Dec 24, 2015 | Supplement 18Labeling · Standard review | Approved | |
| Sep 18, 2015 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Aug 6, 2015 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Apr 23, 2015 | Supplement 15Labeling · Standard review | Approved | |
| Apr 17, 2014 | Supplement 14Labeling · Standard review | Approved | |
| Aug 21, 2013 | Supplement 13Labeling · Standard review | Approved | |
| Jul 30, 2013 | Supplement 11Labeling · Standard review | Approved | |
| Jun 10, 2013 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jan 25, 2013 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jan 15, 2013 | Supplement 8Labeling · Standard review | Approved | |
| Nov 27, 2012 | Supplement 10REMS | Approved | |
| Nov 27, 2012 | Supplement 7Labeling · Standard review | Approved | |
| Nov 23, 2012 | Supplement 6Labeling | Approved | |
| Aug 21, 2012 | Supplement 5Labeling · Standard review | Approved | |
| Aug 18, 2011 | Supplement 4Labeling · Standard review | Approved | |
| Aug 18, 2011 | Supplement 2Labeling · Standard review | Approved | |
| Jun 22, 2010 | Original applicationNew combination · 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
