Drug Master Files for: cevimeline hydrochloride

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cevimeline hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13074	A	II	7/17/1998	ISHIHARA SANGYO KAISHA LTD	CEVIMELINE HYDROCHLORIDE
22200	A	II	11/17/2008	EXCELLA GMBH AND CO KG	CEVIMELINE HYDROCHLORIDE
22509	A	II	2/6/2009	APOTEX PHARMACHEM INC	CEVIMELINE HYDROCHLORIDE HEMIHYDRATE
24949	A	II	10/31/2011	APICORE US LLC	CEVIMELINE HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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