Drug Master Files for: EPROSARTAN MESYLATE

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EPROSARTAN MESYLATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15475	I	II	5/29/2001	LONZA LTD	EPROSARTAN
16703	I	II	7/14/2003	DISHMAN PHARMACEUTICALS AND CHEMICALS LTD	EPROSARTAN MESYLATE
16790	I	II	8/22/2003	LONZA LTD	EPROSARTAN MESYLATE (ROUTE F)
18079	I	II	2/9/2005	LONZA AG	EPROSARTAN MESYLATE (ROUTE F1)
18155	A	II	3/7/2005	DISHMAN CARBOGEN AMCIS LTD	EPROSARTAN MESYLATE
22863	A	II	8/31/2009	JUBILANT GENERICS LTD	EPROSARTAN MESYLATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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