Drug Master Files for: LOVASTATIN

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LOVASTATIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11336	I	II	12/2/1996	ANTIBIOTIC CO	LOVASTATIN
11502	A	II	5/12/1995	TEVA PHARMACEUTICAL INDUSTRIES LTD	LOVASTATIN USP
12133	A	II	9/17/1996	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	LOVASTATIN USP
12400	I	II	3/2/1997	ZHEJIANG RUIBANG LABORATORIES INC	LOVASTATIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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