Drug Master Files for: VALGANCICLOVIR HYDROCHLORIDE

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VALGANCICLOVIR HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
19060	I	II	12/21/2005	SUN PHARMACEUTICAL INDUSTRIES LTD	VALGANCICLOVIR HYDROCHLORIDE (NON-STERILE BULK)
23044	A	II	8/4/2009	OLON SPA	VALGANCICLOVIR HYDROCHLORIDE AMORPHOUS
23322	A	II	11/30/2009	MYLAN LABORATORIES LTD	VALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE)
23859	A	II	5/27/2010	MYLAN LABORATORIES LTD	VALGANCICLOVIR HYDROCHLORIDE USP (AMORPHOUS)
23946	I	II	7/6/2010	SUN PHARMACEUTICAL INDUSTRIES LTD	VALGANCICLOVIR HYDROCHLORIDE, USP (PROCESS 2; SITE TOANSA)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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