Drug Master Files for: TAMOXIFEN CITRATE

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TAMOXIFEN CITRATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10681	I	II	12/15/1993	CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD	TAMOXIFEN CITRATE
15121	I	II	10/31/2000	EGIS PHARMACEUTICALS PRIVATE LTD	TAMOXIFEN CITRATE BULK
19284	I	II	3/8/2006	YANGTZE RIVER PHARMACY GROUP JIANGSU HAI CI BIOLOGICAL PHARMACY CO LTD	TAMOXIFEN CITRATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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