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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

MEXILETINE HYDROCHLORIDE

ANDA

Tentative Approval

MEXILETINE HYDROCHLORIDE | A214598 | ZYDUS PHARMS

API Supply Chain7 active DMFs3 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

MEDICHEM SAMEXILETINE HYDROCHLORIDE

DMF 92571991

ALEMBIC PHARMACEUTICALS LTDMEXILETINE HYDROCHLORIDE USP

DMF 247142011

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMEXILETINE HYDROCHLORIDE

DMF 346682020

COHANCE LIFESCIENCES LTDMEXILETINE HYDROCHLORIDE USP

DMF 349582020

KALINTIS HEALTHCARE PVT LTDMEXILETINE HYDROCHLORIDE USP

DMF 351462020

HETERO DRUGS LTDMEXILETINE HYDROCHLORIDE

DMF 359832021

MACLEODS PHARMACEUTICALS LTDMEXILETINE HYDROCHLORIDE USP

DMF 360972021

FINE CHEMICALS CORPInactiveMEXILETINE HYDROCHLORIDE

DMF 97861992

ICN HUNGARY COMPANY LTDInactiveMEXILETINE HYDROCHLORIDE USP BULK

DMF 103761993

SLOVAKOFARMA ASInactiveMEXILETINE HYDROCHLORIDE

DMF 144421999

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (3)

Sort:

#001 — 150MG

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CAPSULE;ORAL | Approved: 2026-09-23 00:00:00

No patent or exclusivity listings for this strength.

#002 — 200MG

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CAPSULE;ORAL | Approved: 2026-09-23 00:00:00

#003 — 250MG

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CAPSULE;ORAL | Approved: 2026-09-23 00:00:00