# XYREM
> **NDA021196** · New Drug Application · Sponsor: JAZZ PHARMS · Approved 2002-07-17
## Drug
- **FDA Application Number:** NDA021196
- **Application type:** New Drug Application
- **Brand name:** XYREM
- **Generic name:** SODIUM OXYBATE
- **Active ingredients:** SODIUM OXYBATE
- **Dosage form:** SOLUTION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** JAZZ PHARMS
- **Manufacturer:** Hikma Pharmaceuticals USA Inc.
- **First approval:** 2002-07-17
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021196)
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