Drug Master Files for: OSPEMIFENE

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OSPEMIFENE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
25541	A	II	11/30/2011	FERMION OY	OSPEMIFENE
29720	A	II	9/24/2015	OLON SPA	OSPEMIFENE
30474	A	II	6/13/2016	TIANJIN WEIJIE PHARMACEUTICAL CO LTD	OSPEMIFENE
30574	A	II	6/30/2016	GLENMARK PHARMACEUTICALS LTD	OSPEMIFENE
30858	A	II	10/17/2016	HONOUR LAB LTD	OSPEMIFENE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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