Drug Master Files for: FONDAPARINUX SODIUM

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FONDAPARINUX SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15257	I	II	1/19/2001	GLAXO GROUP LTD DBA GLAXOSMITHKLINE	FONDAPARINUX SODIUM
15259	I	II	1/22/2001	SANOFI CHIMIE	FONDAPARINUX SODIUM
22579	A	II	2/26/2009	DR REDDYS LABORATORIES LTD	FONDAPARINUX SODIUM USP
23863	A	II	6/28/2010	APICORE US LLC	FONDAPARINUX SODIUM 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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