Drug Master Files for: sevelamer carbonate

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sevelamer carbonate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14695	I	II	2/24/2000	DOW CHEMICAL CO	SEVELAMER HYDROCHLORIDE
21104	A	II	11/29/2007	SOLARA A PHARMA SCIENCES LTD	SEVELAMER HYDROCHLORIDE
21488	A	II	3/31/2008	LUPIN LTD	SEVELAMER HYDROCHLORIDE
22069	A	II	10/8/2008	EMCURE PHARMACEUTICALS LTD	SEVELAMER HYDROCHLORIDE (PROCESS-I)
22113	I	II	11/4/2008	USV PRIVATE LTD	SEVELAMER HYDROCHLORIDE
22262	I	II	12/3/2008	CHEMO IBERICA SA MADRID	SEVELAMER CARBONATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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