Drug Master Files for: FOSPHENYTOIN SODIUM

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FOSPHENYTOIN SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16899	I	II	10/8/2003	RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA	FOSPHENYTOIN SODIUM API
17333	A	II	4/26/2004	SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD	FOSPHENYTOIN SODIUM USP
18806	A	II	9/25/2005	DIVIS LABORATORIES LTD	FOSPHENYTOIN SODIUM USP
18954	I	II	11/14/2005	CILAG AG	FOSPHENYTOIN SODIUM DRUG SUBSTANCE (A PHARMACEUTICAL INGREDIENT)
19455	A	II	5/25/2006	SUN PHARMACEUTICAL INDUSTRIES LTD	FOSPHENYTOIN SODIUM USP
20511	I	II	5/7/2007	DR REDDYS LABORATORIES LTD	FOSPHENYTOIN SODIUM
20970	A	II	10/24/2007	TRIFARMA SPA	FOSPHENYTOIN SODIUM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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