# SINGULAIR
> **NDA021409** · New Drug Application · Sponsor: ORGANON · Approved 2002-07-26
## Drug
- **FDA Application Number:** NDA021409
- **Application type:** New Drug Application
- **Brand name:** SINGULAIR
- **Generic name:** MONTELUKAST SODIUM
- **Active ingredients:** MONTELUKAST SODIUM
- **Dosage form:** GRANULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ORGANON
- **Manufacturer:** Organon LLC
- **First approval:** 2002-07-26
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021409)
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