Drug Master Files for: dofetilide

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dofetilide Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
27816	A	II	2/25/2014	JOHNSON MATTHEY PHARMA SERVICES	4245.C (MILLED) [DOFETILIDE]
28301	A	II	6/5/2014	SIGMAPHARM LABORATORIES LLC	AMORPHOUS DOFETILIDE
29722	A	II	10/7/2015	APICORE US LLC	DOFETILIDE USP, POLYMORPH P162B
30042	A	II	12/17/2015	INDUSTRIALE CHIMICA SRL	DOFETILIDE USP
30508	A	II	6/29/2016	BIDDLE SAWYER PHARMA LLC	DOFETILIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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