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Last Updated: June 7, 2020

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Drug Master Files for: fludeoxyglucose f-18


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fludeoxyglucose f-18 Drug Master Files

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
30031 A IV 11/16/2015 ROTEM INDUSTRIES LTD DILUENT FOR USE IN F-18 FLUDEOXYGLUCOSE MANUFACTURING
9056 I V 4/9/1991 INSTITUTE CLINICAL PET CLINICAL AND PRECLINCAL DATA ON FLUDEOXYGLUCOSE F-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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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