Drug Master Files for: phenytoin

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phenytoin Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16301	A	II	12/5/2002	ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE	PHENYTOIN SODIUM
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
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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