# OZOBAX DS
> **NDA208193** · New Drug Application · Sponsor: METACEL PHARMS LLC · Approved 2019-09-18
## Drug
- **FDA Application Number:** NDA208193
- **Application type:** New Drug Application
- **Brand name:** OZOBAX DS
- **Generic name:** BACLOFEN
- **Active ingredients:** BACLOFEN
- **Dosage form:** SOLUTION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** METACEL PHARMS LLC
- **Manufacturer:** Palmetto Pharmaceuticals Inc.
- **First approval:** 2019-09-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208193)
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