Drug Master Files for: CHOLESTYRAMINE

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CHOLESTYRAMINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21726	I	II	3/17/2008	THERMAX LTD CHEMICAL DIV	TULSION 412 CHL (CHOLESTYRAMINE RESIN USP)
23171	A	II	10/5/2009	ION EXCHANGE INDIA LTD	CHOLESTYRAMINE RESIN USP (INDION 454)
27607	A	II	8/2/2013	PHAEX POLYMERS PRIVATE LTD	CHOLESTYRAMINE RESIN USP AS IN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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