Drug Master Files for: MIFEPRISTONE

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MIFEPRISTONE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20504	I	II	5/1/2007	PCAS	MIFEPRISTONE
20949	I	II	10/17/2007	CRYSTAL PHARMA SAU	MIFEPRISTONE, MICRONIZED
21944	I	II	9/8/2008	ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO LTD	MIFEPRISTONE
24628	A	II	1/30/2011	QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD	MIFEPRISTONE
27474	A	II	9/13/2013	FORMOSA LABORATORIES INC	MIFEPRISTONE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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