Drug Master Files for: glutethimide

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glutethimide Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12616	I	II	6/9/1997	GEDEON RICHTER LTD	GLUTETHIMIDE
1914	I	II	4/12/1972	TROPONWERKE GMBH CO KG	GLUTETHIMIDE
2293	I	II	6/21/1974	GANES CHEMICALS INC PENNSVILLE DIV	GLUTETHIMIDE BULK
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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