Drug Master Files for: urea

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urea Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10161	I	II	3/23/1993	PERKIN ELMER LIFE SCIENCES	[14C]-UREA
1077	I	II	8/25/1967	ER SQUIBB AND SONS INC	MANUFACTURE OF HYDROXYUREA
11378	A	II	3/16/1995	CAMBRIDGE ISOTOPE LABORATORIES INC	13C UREA
11455	A	II	4/17/1995	ALDRICH CHEMICAL CO	UREA-13 C
11685	I	II	4/20/1995	SYNTHELABO PHARMACIE	UREA-CALCIUM ACETYLSALICYLATE
11899	A	II	3/25/1996	OLON SPA	HYDROXYUREA
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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