# BACLOFEN
> **ANDA091193** · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2016-05-03
## Drug
- **FDA Application Number:** ANDA091193
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** BACLOFEN
- **Generic name:** Baclofen
- **Active ingredients:** BACLOFEN
- **Dosage form:** INJECTABLE
- **Route:** INTRATHECAL
- **Marketing status:** Prescription
- **Sponsor:** AMNEAL
- **First approval:** 2016-05-03
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=091193)
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