Drug Master Files for: icosapent ethyl

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icosapent ethyl Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
22077	I	II	10/9/2008	CHEMPORT INC	EICOSAPENTAENOIC ACID, 90% ETHYL ESTER
23911	A	II	7/7/2010	PRONOVA BIOPHARMA NORGE AS	EICOSAPENTAENOIC ACID ETHYL ESTER (EPA-E)
26271	A	II	8/1/2012	CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD	ETHYL ICOSAPENTATE
26892	A	II	2/26/2013	KD PHARMA BEXBACH GMBH	EICOSAPENTAENOIC ACID ETHYL ESTER
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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