# REMERON SOLTAB
> **NDA021208** · New Drug Application · Sponsor: ORGANON USA ORGANON · Approved 2001-01-12
## Drug
- **FDA Application Number:** NDA021208
- **Application type:** New Drug Application
- **Brand name:** REMERON SOLTAB
- **Generic name:** MIRTAZAPINE
- **Active ingredients:** MIRTAZAPINE
- **Dosage form:** TABLET, ORALLY DISINTEGRATING
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ORGANON USA ORGANON
- **Manufacturer:** Organon LLC
- **First approval:** 2001-01-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021208)
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