Drug Master Files for: FLUCYTOSINE

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FLUCYTOSINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15476	I	II	6/7/2001	ACETO CORP	FLUCYTOSINE USP
23503	A	II	1/22/2010	CALYX CHEMICALS AND PHARMACEUTICALS LTD	FLUCYTOSINE
25094	A	II	7/14/2011	NANTONG JINGHUA PHARMACEUTICAL CO LTD	FLUCYTOSINE
28247	A	II	6/16/2014	APICORE US LLC	FLUCYTOSINE, USP
31959	A	II	8/30/2017	MAITHRI LABORATORIES PRIVATE LTD	FLUCYTOSINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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