Drug Master Files for: VALSARTAN

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VALSARTAN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17897	I	II	12/15/2004	SUN PHARMACEUTICAL INDUSTRIES LTD	VALSARTAN USP
17909	A	II	12/16/2004	TEVA PHARMACEUTICAL INDUSTRIES LTD	VALSARTAN
18253	A	II	4/7/2005	MYLAN LABORATORIES LTD	VALSARTAN USP
18967	A	II	11/22/2005	JUBILANT GENERICS LTD	VALSARTAN 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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