Drug Master Files for: colesevelam hydrochloride

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colesevelam hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
22870	A	II	6/16/2009	FORMOSA LABORATORIES INC	COLESEVELAM HYDROCHLORIDE
23333	A	II	4/6/2010	LUPIN LTD	COLESEVELAM HYDROCHLORIDE
23378	A	II	12/16/2009	SOLARA A PHARMA SCIENCES LTD	COLESEVELAM HYDROCHLORIDE
25696	I	II	3/20/2012	USV LTD	COLESEVELAM HYDROCHLORIDE
26813	I	II	2/5/2013	IND SWIFT LABORATORIES LTD	COLESEVELAM HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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