Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsINHALATIONStandard

DULERA

FORMOTEROL FUMARATE; MOMETASONE FUROATE

Standard Dose
0.005MG/INH;0.1MG/INH
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary

Approval overview DULERA is listed in Drugs@FDA under application 022518 (NDA).

Review priority: N/A Marketing status: Prescription Active ingredient FORMOTEROL FUMARATE; MOMETASONE FUROATE Form and strength AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH Sponsor ORGANON LLC Submission history Latest submission status date: 2025-06-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview DULERA is listed in Drugs@FDA under application 022518 (NDA). Review priority: N/A Marketing status: Prescription Active ingredient FORMOTEROL FUMARATE; MOMETASONE FUROATE Form and strength AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH Sponsor ORGANON LLC Submission history Latest submission status date: 2025-06-05 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.