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Dulera Approval History

  • FDA approved: Yes (First approved June 22nd, 2010)
  • Brand name: Dulera
  • Generic name: mometasone furoate and formoterol fumarate
  • Dosage form: Inhaler
  • Company: Merck & Co., Inc.
  • 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 12 years of age and older.

Development History and FDA Approval Process for Dulera

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

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