← FDA DRUG APPROVALS

FDA NDA · NDA022518

DULERA

mometasone furoate and formoterol fumarate dihydrate

Sponsor: ORGANON LLC

APPLICATION
NDA022518
TYPE
NDA
ORIGINAL APPROVAL
2010-06-22
LATEST ACTION
2025-06-05
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Prescription

Products

DULERA · ReferencePrescription
FORMOTEROL FUMARATE 0.005MG/INH, MOMETASONE FUROATE 0.2MG/INH · AEROSOL, METERED · INHALATION
DULERA · ReferencePrescription
FORMOTEROL FUMARATE 0.005MG/INH, MOMETASONE FUROATE 0.05MG/INH · AEROSOL, METERED · INHALATION
DULERA · ReferencePrescription
FORMOTEROL FUMARATE 0.005MG/INH, MOMETASONE FUROATE 0.1MG/INH · AEROSOL, METERED · INHALATION

Approval history

2025-06-05Manufacturing (CMC) · Supplement 33 — Letter ↗AP
2019-08-12Efficacy · Supplement 26 · priority — Letter ↗AP
2018-03-23Labeling · Supplement 24 · standard — Label ↗AP
2018-03-23Labeling · Supplement 23 · standard — Label ↗AP
2017-12-20Efficacy · Supplement 22 · standard — Label ↗AP
2017-06-27Labeling · Supplement 21 · standard — Label ↗AP
2016-07-12Efficacy · Supplement 19 · standard — Pediatric Medical Review ↗AP
2016-05-12Manufacturing (CMC) · Supplement 20 · standardAP
2015-12-24Labeling · Supplement 18 · standard — Letter ↗AP
2015-09-18Manufacturing (CMC) · Supplement 17 · standardAP
2015-08-06Manufacturing (CMC) · Supplement 16 · standardAP
2015-04-23Labeling · Supplement 15 · standard — Label ↗AP
2014-04-17Labeling · Supplement 14 · standard — Letter ↗AP
2013-08-21Labeling · Supplement 13 · standard — Label ↗AP
2013-07-30Labeling · Supplement 11 · standard — Letter ↗AP
2013-06-10Manufacturing (CMC) · Supplement 12 · standardAP
2013-01-25Manufacturing (CMC) · Supplement 9 · standardAP
2013-01-15Labeling · Supplement 8 · standard — Letter ↗AP
2012-11-27REMS · Supplement 10 — Letter ↗AP
2012-11-27Labeling · Supplement 7 · standard — Letter ↗AP
2012-11-23Labeling · Supplement 6 · unknown — Letter ↗AP
2012-08-21Labeling · Supplement 5 · standard — Label ↗AP
2011-08-18Labeling · Supplement 4 · standard — Label ↗AP
2011-08-18Labeling · Supplement 2 · standard — Label ↗AP
2010-06-22Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →