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MEXILETINE HYDROCHLORIDE

ANDA

MEXILETINE HYDROCHLORIDE | A213500 | CROSSMEDIKA SA

3 strengths0 unique patents0 unique exclusivities

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 24, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 150MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 22, 2020

No patent or exclusivity listings for this strength.

#002 — 200MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jul 22, 2020

#003 — 250MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jul 22, 2020