Drug Master Files for: ranolazine

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ranolazine Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21866	A	II	8/7/2008	AARTI INDUSTRIES LTD	RANOLAZINE
21966	A	II	12/3/2008	CIPLA LTD	RANOLAZINE
22350	A	II	12/22/2008	MSN PHARMACHEM PRIVATE LTD	RANOLAZINE [ROUTE CODE - RA]
22811	A	II	6/15/2009	COSMA SPA	RANOLAZINE
23245	A	II	12/24/2009	LUPIN LTD	RANOLAZINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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