Drug Master Files for: ATORVASTATIN CALCIUM

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ATORVASTATIN CALCIUM Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16098	I	II	8/19/2002	RANBAXY LABORATORIES LTD	ATORVASTATIN CALCIUM(AMORPHOUS)
17484	I	II	6/21/2004	RANBAXY LABORATORIES LTD	ATORVASTATIN MAGNESIUM
18082	A	II	2/1/2005	LEK PHARMACEUTICALS DD	ATORVASTATIN CALCIUM
18122	I	II	2/23/2005	MOREPEN LABORATORIES LTD	ATORVASTATIN CALCIUM
18402	I	II	6/6/2005	MOREPEN LABORATORIES LTD	ATORVASTATIN CALCIUM AMORPHOUS, BULK SUBSTANCE
18468	A	II	6/29/2005	DR REDDYS LABORATORIES LTD	ATORVASTATIN CALCIUM (AMORPHOUS)
18822	A	II	9/30/2005	CADILA HEALTHCARE LTD	ATORVASTATIN PROTECTED DIOL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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