# DEFITELIO
> **NDA208114** · New Drug Application · Sponsor: JAZZ PHARMS INC · Approved 2016-03-30
## Drug
- **FDA Application Number:** NDA208114
- **Application type:** New Drug Application
- **Brand name:** DEFITELIO
- **Generic name:** DEFIBROTIDE SODIUM
- **Active ingredients:** DEFIBROTIDE SODIUM
- **Dosage form:** SOLUTION
- **Route:** INTRAVENOUS
- **Marketing status:** Prescription
- **Sponsor:** JAZZ PHARMS INC
- **Manufacturer:** Jazz Pharmaceuticals, Inc.
- **First approval:** 2016-03-30
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208114)
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