Drug Master Files for: riluzole

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riluzole Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15252	A	II	1/16/2001	SCINOPHARM TAIWAN LTD	RILUZOLE
22107	A	II	10/22/2008	GLENMARK PHARMACEUTICALS LTD	RILUZOLE USP
22438	A	II	3/16/2009	SUN PHARMACEUTICAL INDUSTRIES LTD	RILUZOLE USP
22596	A	II	3/5/2009	APOTEX PHARMACHEM INDIA PVT LTD	RILUZOLE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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