Drug Master Files for: SUCRALFATE

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SUCRALFATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11876	I	II	2/28/1996	BK GIULINI GMBH	SUCRALFATE POWDER
16589	A	II	5/13/2003	EUTICALS SPA	SUCRALFATE
30056	A	II	2/3/2016	ZHEJIANG HAISEN PHARMACEUTICAL CO LTD	SUCRALFATE NON STERILE BULK DRUG SUBSTANCE
3542	A	II	6/12/1979	CHUGAI PHARMACEUTICAL CO LTD	SUCRALFATE
5454	I	II	6/25/1984	ORION CORP LTD	SUCRALFATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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