# BACLOFEN
> **ANDA211659** · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS LIFESCIENCES · Approved 2018-11-23
## Drug
- **FDA Application Number:** ANDA211659
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BACLOFEN
- **Generic name:** BACLOFEN
- **Active ingredients:** BACLOFEN
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ZYDUS LIFESCIENCES
- **Manufacturer:** Zydus Pharmaceuticals (USA) Inc.
- **First approval:** 2018-11-23
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211659)
---
*AI Analytics · CC0 1.0*