Drug Master Files for: PRAVASTATIN SODIUM

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PRAVASTATIN SODIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14235	A	II	6/24/1999	CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD	PRAVASTATIN SODIUM USP
14729	A	II	2/25/2000	TEVA PHARMACEUTICAL INDUSTRIES LTD	PRAVASTATIN SODIUM
15922	I	II	4/3/2002	LEK PHARMACEUTICALS DD	PRAVASTATIN SODIUM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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