Drug Master Files for: MEXILETINE HYDROCHLORIDE

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MEXILETINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10376	I	II	7/26/1993	ICN HUNGARY COMPANY LTD	MEXILETINE HYDROCHLORIDE USP BULK
14442	I	II	10/7/1999	SLOVAKOFARMA AS	MEXILETINE HYDROCHLORIDE
24714	A	II	3/9/2011	ALEMBIC PHARMACEUTICALS LTD	MEXILETINE HYDROCHLORIDE USP
9257	A	II	7/26/1991	MEDICHEM SA	MEXILETINE HYDROCHLORIDE
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

Drug Master File Glossary

STATUS OF DMFS

A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
I = Inactive
N = Not an assigned number
P = DMF Pending Filing Review

TYPES OF DMFs

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

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