Drug Master Files for: thalidomide

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thalidomide Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15291	I	II	2/19/2001	SIFAVITOR SPA	THALIDOMIDE
18448	A	II	6/23/2005	OLON SPA	THALIDOMIDE
19745	A	II	9/11/2006	HETERO LABS LTD	THALIDOMIDE USP
21806	A	II	7/28/2008	FIS FABBRICA ITALIANA SINTETICI SPA	THALIDOMIDE
22678	I	II	3/31/2009	DR REDDYS LABORATORIES LTD	THALIDOMIDE
27967	A	II	3/5/2014	LAURUS LABS LTD	THALIDOMIDE USP
29452	A	II	6/30/2015	MYLAN LABORATORIES LTD	THALIDOMIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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