Drug Master Files for: pitavastatin calcium

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pitavastatin calcium Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14660	A	II	1/11/2000	NISSAN CHEMICAL CORP	PITAVASTATIN CALCIUM
23488	A	II	1/27/2010	MSN LABORATORIES PRIVATE LTD	PITAVASTATIN CALCIUM [ROUTE CODE: PC]
25956	A	II	4/11/2012	SOLARA A PHARMA SCIENCES LTD	PITAVASTATIN CALCIUM
26406	I	II	12/16/2012	ZHEJIANG HISUN PHARMACEUTICAL CO LTD	PITAVASTATIN CALCIUM
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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