Drug Master Files for: simvastatin

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simvastatin Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14599	A	II	11/29/1999	TEVA PHARMACEUTICAL INDUSTRIES LTD	SIMVASTATIN
15722	I	II	11/7/2001	SUN PHARMACEUTICAL INDUSTRIES LTD	SIMVASTATIN USP
16094	I	II	8/12/2002	BIOCON LTD	SIMVASTATIN USP
16305	A	II	12/11/2002	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	SIMVASTATIN USP
17151	I	II	2/10/2004	KREBS BIOCHEMICALS INDUSTRIES LTD	SIMVASTATIN USP
17568	I	II	7/27/2004	LEK PHARMACEUTICALS DD	SIMVASTATIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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