Drug Master Files for: warfarin potassium

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warfarin potassium Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10530	I	II	8/14/1993	MEDEA RESEARCH LABORATORIES INC	WARFARIN SODIUM
11387	A	II	3/15/1995	APOTEX PHARMACHEM INC	WARFARIN SODIUM CLATHRATE USP
12117	I	II	8/27/1996	NAPP TECHNOLOGIES INC	WARFARIN SODIUM CLATHRATE
12269	A	II	12/16/1996	TEVA PHARMACEUTICAL INDUSTRIES LTD	WARFARIN SODIUM CLATHRATE
12704	I	II	10/21/1997	SHANGHAI SHEN XING PHARMACEUTICAL FACTORY	WARFARIN SODIUM, USP
12746	A	II	11/18/1997	TARO PHARMACEUTICAL INDUSTRIES LTD	WARFARIN SODIUM CLATHRATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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