Drug Master Files for: ATOVAQUONE

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ATOVAQUONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20672	I	II	7/6/2007	USV LTD	ATOVAQUONE USP
20908	A	II	10/3/2007	CADILA HEALTHCARE LTD	ATOVAQUONE USP
21001	I	II	10/1/2007	ZHEJIANG HISOAR PHARMACEUTICAL CO LTD	Atovaquone
21360	A	II	2/15/2008	ROLABO OUTSOURCING SL	ATOVAQUONE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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