Drug Master Files for: PROBUCOL

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PROBUCOL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17355	A	II	4/26/2004	SCI PHARMTECH INC	PROBUCOL
2167	I	II	10/17/1973	HOECHST MARION ROUSSEL INC	PROBUCOL (DH-581)
7579	I	II	7/18/1988	MEDICHEM SA	PROBUCOL
7761	I	II	11/22/1988	SUMIKA FINE CHEMICALS CO LTD	PROBUCOL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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