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 |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
