Drug Master Files for: FLECAINIDE ACETATE

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FLECAINIDE ACETATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10688	A	II	1/24/1994	MAPRIMED SA	FLECAINIDE ACETATE PROCESS I (CODE 50064)
14749	A	II	2/29/2000	AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA	FLECAINIDE ACETATE
15244	A	II	1/15/2001	POLYCARBON INDUSTRIES INC DBA PCI SYNTHESIS	FLECAINIDE ACETATE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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