Drug Master Files for: glimepiride

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glimepiride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15882	A	II	2/13/2002	CHONGQING CARELIFE PHARMACEUTICAL CO LTD	GLIMEPIRIDE USP
16713	A	II	7/18/2003	USV PRIVATE LTD	GLIMEPIRIDE USP
16736	A	II	7/28/2003	MEDICHEM SA	GLIMEPIRIDE
16983	A	II	11/26/2003	DR REDDYS LABORATORIES LTD	GLIMEPIRIDE USP
17048	I	II	12/15/2003	ZACH SYSTEM SPA	GLIMEPIRIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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