Drug Master Files for: FLUVASTATIN SODIUM

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FLUVASTATIN SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17879	I	II	12/7/2004	CADILA HEALTHCARE LTD	FLUVASTATIN SODIUM
18493	A	II	7/7/2005	BIOCON LTD	FLUVASTATIN SODIUM AMORPHOUS
18762	A	II	9/13/2005	BIOCON LTD	FLUVASTATIN SODIUM
18911	A	II	10/11/2005	FIS FABBRICA ITALIANA SINTETICI SPA	FLUVASTATIN SODIUM HYDRATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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