Drug Master Files for: FOMEPIZOLE

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FOMEPIZOLE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19151	A	II	2/3/2006	ALCAMI WISCONSIN CORP	FP-059 (FOMEPIZOLE) DRUG SUBSTANCE
19472	A	II	5/24/2006	APICORE US LLC	FOMEPIZOLE
19683	A	II	8/10/2006	NAVINTA LLC	FOMEPIZOLE
19978	A	II	12/13/2006	CHEMWERTH INC	FOMEPIZOLE
20305	A	II	2/26/2007	SERATEC SAS	FOMEPIZOLE (4-METHYLPYRAZOLE)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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