# MEXILETINE HYDROCHLORIDE
> **ANDA214598** · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2026-09-23
## Drug
- **FDA Application Number:** ANDA214598
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** MEXILETINE HYDROCHLORIDE
- **Generic name:** Mexiletine Hydrochloride
- **Active ingredients:** MEXILETINE HYDROCHLORIDE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ZYDUS PHARMS
- **First approval:** 2026-09-23
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214598)
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