Drug Master Files for: QUETIAPINE FUMARATE

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QUETIAPINE FUMARATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17122	A	II	1/29/2004	DR REDDYS LABORATORIES LTD	QUETIAPINE FUMARATE USP
18341	A	II	5/9/2005	TEVA PHARMACEUTICAL INDUSTRIES LTD	QUETIAPINE FUMARATE DRUG SUBSTANCE
18797	I	II	9/12/2005	IND SWIFT LABORATORIES LTD	QUETIAPINE FUMARATE
18869	A	II	10/14/2005	MYLAN LABORATORIES LTD	QUETIAPINE FUMARATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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