Drug Master Files for: FLUVOXAMINE MALEATE

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FLUVOXAMINE MALEATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12353	I	II	2/4/1997	VIS FARMACEUTICI INSTITUTO SCIENTIFICO VINEZIE SPA	FLUVOXAMINE MALEATE
13892	I	II	12/10/1998	DIOSYNTH BV	FLUVOXAMINE MALEATE
13913	A	II	12/23/1998	TEVA PHARMACEUTICAL INDUSTRIES LTD	FLUVOXAMINE MALEATE
13957	I	II	1/22/1999	ALKERMES INC	FLUVOXAMINE MALEATE CR CAPSULES
14511	A	II	10/29/1999	MEDICHEM SA	FLUVOXAMINE MALEATE
14529	A	II	11/12/1999	APOTEX PHARMACHEM INDIA PVT LTD	FLUVOXAMINE MALEATE USP
16174	A	II	9/24/2002	SUN PHARMACEUTICAL INDUSTRIES LTD	FLUVOXAMINE MALEATE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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