Drug Master Files for: ZILEUTON

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ZILEUTON Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
24334	A	II	4/1/2011	APICORE US LLC	ZILEUTON USP
24827	A	II	4/5/2011	MSN LABORATORIES PRIVATE LTD	ZILEUTON USP [ROUTE CODE ZN]
25805	A	II	3/26/2012	EMCURE PHARMACEUTICALS LTD	ZILEUTON USP
26446	A	II	9/26/2012	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	ZILEUTON
26995	A	II	3/15/2013	ERREGIERRE SPA	ZILEUTON USP
27679	I	II	10/30/2013	FARMAK AS	ZILEUTON
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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