Drug Master Files for: CLOZAPINE

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CLOZAPINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10534	A	II	10/21/1993	MEDICHEM SA	CLOZAPINE
10862	A	II	4/5/1994	AREVIPHARMA GMBH	CLOZAPINE
11098	I	II	9/26/1994	SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT	CLOZAPINE
11195	A	II	11/16/1994	SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD	CLOZAPINE
11692	A	II	10/3/1995	CAMBREX PROFARMACO MILANO SRL	CLOZAPINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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