Drug Master Files for: GUERBET

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GUERBET Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10121	I	II	3/5/1993	GUERBET CHIMIE AULNAY	SYNTHESIS OF P607 IN AULNAY SOUS BOIS, FRANCE.
11270	I	II	12/27/1994	GUERBET CHIMIE AULNAY SA	IOXITOL
2230	I	II	2/4/1974	ANDRE GUERBET LABORATORIES	IOCARMIC ACID
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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