# LOFEXIDINE HYDROCHLORIDE
> **ANDA219917** · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2025-10-22
## Drug
- **FDA Application Number:** ANDA219917
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** LOFEXIDINE HYDROCHLORIDE
- **Generic name:** LOFEXIDINE
- **Active ingredients:** LOFEXIDINE HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** NOVITIUM PHARMA
- **Manufacturer:** ANI Pharmaceuticals, Inc.
- **First approval:** 2025-10-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219917)
---
*AI Analytics · CC0 1.0*