# PHEBURANE
> **NDA216513** · New Drug Application · Sponsor: MEDUNIK · Approved 2022-06-17
## Drug
- **FDA Application Number:** NDA216513
- **Application type:** New Drug Application
- **Brand name:** PHEBURANE
- **Generic name:** SODIUM PHENYLBUTYRATE
- **Active ingredients:** SODIUM PHENYLBUTYRATE
- **Dosage form:** PELLETS
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** MEDUNIK
- **Manufacturer:** Medunik USA
- **First approval:** 2022-06-17
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216513)
---
*MORVS · CC0 1.0*