Drug Master Files for: DIFLUNISAL

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DIFLUNISAL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
24762	A	II	3/15/2011	AARTI INDUSTRIES LTD	DIFLUNISAL
25743	I	II	6/18/2012	JUHUA GROUP CORP PHARMACEUTICAL FACTORY	DIFLUNISAL USP
28951	A	II	1/12/2015	APICORE US LLC	DIFLUNISAL, USP
3852	I	II	6/23/1980	MERCK SHARP & DOHME RESEARCH LABS	DIFLUNISAL
7492	A	II	5/22/1988	CHEMI SPA	DIFLUNISAL
8163	I	II	8/2/1989	CAMBREX PROFARMACO MILANO SRL	DIFLUNISAL
9060	I	II	4/15/1991	ZAMBON GROUP SPA	DIFLUNISAL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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