# SODIUM PHENYLBUTYRATE
> **ANDA204395** · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2016-04-15
## Drug
- **FDA Application Number:** ANDA204395
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** SODIUM PHENYLBUTYRATE
- **Generic name:** SODIUM PHENYLBUTYRATE TABLETS, 500 MG
- **Active ingredients:** SODIUM PHENYLBUTYRATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** PH HEALTH
- **Manufacturer:** Par Health USA, LLC
- **First approval:** 2016-04-15
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204395)
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