Drug Master Files for: glyburide

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glyburide Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10297	I	II	6/17/1993	CHINOIN PHARMACEUTICAL CHEMICAL WORKS	GLIBENCLAMIDE BP88 (GLYBURIDE)
11055	I	II	9/1/1994	SELOC FRANCE	GLYBURIDE
11179	I	II	11/4/1994	HOECHST CELANESE CORP	GLYBURIDE
12136	I	II	9/12/1996	AVENTIS PHARMA DEUTSCHLAND GMBH	GLYBURIDE [MILLED (GROUND)]
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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