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Dulera FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved June 22, 2010)
Brand name: Dulera
Generic name: mometasone furoate and formoterol fumarate
Dosage form: Inhaler
Company: Merck
Treatment for: Asthma

Dulera (mometasone furoate and formoterol fumarate) is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for the treatment of asthma in patients 5 years of age and older.

Development timeline for Dulera

DateArticle
Jun 24, 2010Approval FDA Approves Merck's Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol for the Treatment of Asthma in Patients 12 Years of Age and Older
Jul 23, 2009Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma

Further information

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