Drug Master Files for: fluorouracil

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fluorouracil Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1138	I	II	2/2/1968	INTERNATL CHEM & NUCLEAR PHARMS INC	5-FLUOROURACIL
1226	I	II	8/21/1968	PCR INC	5-FLUOROURACIL
12738	A	II	11/11/1997	AMCOL HEALTH AND BEAUTY SOLUTIONS INC	FLUOROURACIL IN MICROSPONGE? POLYMER (FLUROURACIL IN METHYL METHACRYLATE/DIMETHACRYLATE CROSSPOLYMER)
17832	I	II	9/8/2004	NANTONG GENERAL PHARMACEUTICAL FACTORY	FLUOROURACIL
18478	A	II	6/28/2005	NANTONG JINGHUA PHARMACEUTICAL CO LTD	FLUOROURACIL USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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