Drug Master Files for: FLUDEOXYGLUCOSE F-18

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FLUDEOXYGLUCOSE F-18 Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13268	I	II	6/4/1998	GENERAL ELECTRIC MEDICAL SYSTEMS	FLUDEOXYGLUCOSE F-18 INJECTION
24772	A	V	1/31/2011	ROTEM INDUSTRIES LTD	CASSETTE FOR PRODUCTION OF FLUORINE-18 FLUDEOXYGLUCOSE ON THE TRACERLAB MXFDG SYNTHESIS UNIT
25157	A	V	5/18/2011	ROTEM INDUSTRIES LTD	CASSETTE FOR THE PRODUCTION OF FLUORINE-18 FLUDEOXYGLUCOSE ON THE TRACERLAB MX FDG SYNTHESIS UNIT, B AS MANUFACTURED IN MISHOR YAMIN , ISRAEL
29891	A	V	9/25/2015	TRACE-ABILITY INC	ANALYTICAL METHOD TO BE USED FOR QUALITY CONTROL OF FLUDEOXYGLUCOSE (FDG) 18 INJECTION
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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