Drug Master Files for: FLUDARABINE PHOSPHATE

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FLUDARABINE PHOSPHATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14924	I	II	6/15/2000	BAYER SCHERING PHARMA AG	FLUDARABINE PHOSPHATE
15542	I	II	7/25/2001	ASH STEVENS INC	FLUDARABINE PHOSPHATE (ASP)
15742	A	II	11/12/2001	TEVA PHARMACEUTICAL INDUSTRIES LTD	FLUDARABINE PHOSPHATE
16807	A	II	8/27/2003	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	FLUDARABINE PHOSPHATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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