Drug Master Files for: LENALIDOMIDE

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LENALIDOMIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
23410	A	II	12/29/2009	MYLAN LABORATORIES LTD	LENALIDOMIDE
24264	A	II	12/2/2010	APICORE US LLC	LENALIDOMIDE
25872	I	II	3/30/2012	DR REDDYS LABORATORIES LTD	LENALIDOMIDE
27116	A	II	6/4/2013	FIS FABBRICA ITALIANA SINTETICI SPA	LENALIDOMIDE
27905	A	II	2/3/2014	RELIANCE LIFE SCIENCES PVT LTD	LENALIDOMIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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