Drug Master Files for: argatroban

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argatroban Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20709	A	II	7/20/2007	CHEMWERTH INC	ARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE
20760	A	II	8/7/2007	EUTICALS SPA	ARGATROBAN
21304	A	II	1/30/2008	LUNDBECK PHARMACEUTICALS ITALY SPA	ARGATROBAN
22855	A	II	8/14/2009	CHEMWERTH INC	INTERMEDIATE 6 OF ARGATROBAN (ARGA 6)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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