Drug Master Files for: Genzyme Corp

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Genzyme Corp Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10101	I	II	2/25/1993	GENZYME CORP	CERAMIDETRIHEXOSIDASE
10375	I	II	7/26/1993	GENZYME CORP	MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LIESTAL, SWITZERLAND.
10556	I	II	9/30/1993	GENZYME CORP	SODIUM CHOLESTERYL SULPHATE
10923	I	II	5/25/1994	GENZYME CORP	SN-1-PALMITOYL-2-OLEOYLPHOSPHATIDYLGLYCEROL SODIUM SALT (POPG.NA)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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