Drug Master Files for: FULVESTRANT

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FULVESTRANT Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
22174	I	II	11/12/2008	TEVA PHARMACEUTICAL INDUSTRIES LTD	FULVESTRANT
22611	A	II	3/13/2009	SCINOPHARM TAIWAN LTD	FULVESTRANT USP
26835	A	II	3/15/2013	TEVA PHARMACEUTICAL INDUSTRIES LTD	FULVESTRANT
26855	A	II	1/30/2013	STERLING SPA	FULVESTRANT
26893	I	II	3/14/2014	CHEM WERTH INC	FULVESTRANT
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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