# DULERA
> **NDA022518** · New Drug Application · Sponsor: ORGANON LLC · Approved 2010-06-22
## Drug
- **FDA Application Number:** NDA022518
- **Application type:** New Drug Application
- **Brand name:** DULERA
- **Generic name:** MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE
- **Active ingredients:** FORMOTEROL FUMARATE; MOMETASONE FUROATE
- **Dosage form:** AEROSOL, METERED
- **Route:** INHALATION
- **Marketing status:** Prescription
- **Sponsor:** ORGANON LLC
- **Manufacturer:** Organon LLC
- **First approval:** 2010-06-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022518)
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