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Last Updated: April 19, 2024

Drug Master Files for: MIRTAZAPINE

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MIRTAZAPINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10457	A	II	8/30/1993	ASPEN OSS BV	MIRTAZAPINE
15300	I	II	2/22/2001	SUMITOMO CHEMICAL CO LTD	MIRTAZAPINE
15323	A	II	3/2/2001	TEVA PHARMACEUTICAL INDUSTRIES LTD	MIRTAZAPINE
15749	A	II	12/5/2001	MEDICHEM SA	MIRTAZAPINE
16007	A	II	6/11/2002	NEULAND LABORATORIES LTD	MIRTAZAPINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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