# METAXALONE
> **NDA022503** · New Drug Application · Sponsor: PRIMUS PHARMS · Approved 2015-06-01
## Drug
- **FDA Application Number:** NDA022503
- **Application type:** New Drug Application
- **Brand name:** METAXALONE
- **Generic name:** METAXALONE
- **Active ingredients:** METAXALONE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** PRIMUS PHARMS
- **Manufacturer:** INA Pharmaceutics Inc
- **First approval:** 2015-06-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022503)
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