# BACLOFEN
> **ANDA214114** · Abbreviated New Drug Application (Generic) · Sponsor: REGCON HOLDINGS · Approved 2021-07-16
## Drug
- **FDA Application Number:** ANDA214114
- **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:** REGCON HOLDINGS
- **First approval:** 2021-07-16
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214114)
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