Drug Master Files for: PAROXETINE MESYLATE

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PAROXETINE MESYLATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12770	I	II	12/3/1997	APOTEX PHARMACHEM INC	PAROXETINE HYDROCHLORIDE (ANHYDROUS)
13888	I	II	12/7/1998	SUMITOMO CHEMICAL CO LTD	PAROXETINE HYDROCHLORIDE ANHYDRATE
14432	I	II	9/30/1999	ASAHI GLASS CO LTD	PAROXETINE HYDROCHLORIDE AMORPHOUS
14475	I	II	10/13/1999	GLAXOSMITHKLINE	PAROXETINE HYDROCHLORIDE HEMIHYDRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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