Drug Master Files for: HYDROXYUREA

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HYDROXYUREA Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1077	I	II	8/25/1967	ER SQUIBB AND SONS INC	MANUFACTURE OF HYDROXYUREA
11899	A	II	3/25/1996	OLON SPA	HYDROXYUREA
12754	A	II	11/14/1997	EUTICALS SPA	HYDROXYUREA
16458	I	II	2/21/2003	CHEMSPEC	HYDROXYUREA
20615	A	II	6/15/2007	QILU TIANHE PHARMACEUTICAL CO LTD	HYDROXYUREA USP (NON-STERILE BULK)
2258	I	II	4/9/1974	FERMENTA FRANCE SA	HYDROXYUREA BY OLMACO OF EMPERNON,FRANCE (FORMERLY HELD BY OLMACO)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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