Drug Master Files for: ALISKIREN HEMIFUMARATE

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ALISKIREN HEMIFUMARATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
24755	I	II	3/10/2011	CHANGZHOU PHARMACEUTICAL FACTORY	ALISKIREN HEMIFUMARATE
26776	A	II	12/27/2012	CHEMO IBERICA SA	ALISKIREN HEMIFUMARATE
26975	A	II	4/29/2013	MSN LABORATORIES PRIVATE LTD	ALISKIREN HEMIFUMARATE [ROUTE CODE - AF]
28050	A	II	3/31/2014	JUBILANT GENERICS LTD	ALISKIREN HEMIFUMARATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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