Drug Master Files for: DALFAMPRIDINE

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DALFAMPRIDINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17860	A	II	11/29/2004	CU CHEMIE UETIKON GMBH	DALFAMPRIDINE
24718	A	II	3/21/2011	JUBILANT GENERICS LTD	DALFAMPRIDINE USP
25695	I	II	5/15/2012	ENALTEC LABS PRIVATE LTD	DALFAMPRIDINE
27623	A	II	10/18/2013	INDUSTRIALE CHIMICA SRL	DALFAMPRIDINE
27637	A	II	11/1/2013	ALKEM LABORATORIES LTD	DALFAMPRIDINE USP
27647	A	II	10/15/2013	PROCOS SPA	DALFAMPRIDINE
27662	A	II	11/18/2013	SUN PHARMACEUTICAL INDUSTRIES LTD	DALFAMPRIDINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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