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MEXILETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2026-09-23

Drug application

FDA Application #

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

Authoritative

Drugs@FDA application overview

Machine

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