Drug Master Files for: PROPYLTHIOURACIL

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PROPYLTHIOURACIL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
16578	A	II	5/7/2003	CHEMISCHE FABRIK BERG GMBH	PROPYLTHIOURACIL USP
29101	A	II	4/28/2015	MACLEODS PHARMACEUTICALS LTD	PROPYLTHIOURACIL
4928	A	II	3/22/1983	HERBRAND PHARMACHEMICALS GMBH	PROPYLTHIOURACIL
8377	I	II	1/15/1990	ROCHE DIAGNOSTICS GMBH	PROPYLTHIOURACIL
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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