Drug Master Files for: EZETIMIBE

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EZETIMIBE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19717	A	II	8/30/2006	GLENMARK PHARMACEUTICALS LTD	EZETIMIBE (PROCESS I)
20039	A	II	12/13/2006	TEVA PHARMACEUTICAL INDUSTRIES LTD	EZETIMIBE
21554	A	II	4/17/2008	MSN LABORATORIES PRIVATE LTD	EZETIMIBE USP [ROUTE CODE - EB]
22573	I	II	2/25/2009	NEULAND LABORATORIES LTD	EZETIMIBE (FORM-X)
23541	A	II	4/7/2010	LUPIN LTD	EZETIMIBE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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