01 1GENERAL ELECTRIC
02 1HUAYI ISOTOPE CO
03 1Rotem Industries
04 3Blank
01 118F 2-FLUORO-2-DEOXYGLUCOSE
02 118F-FDG REAGENT KITS
03 1DILUENT FOR USE IN F-18 FLUDEOXYGLUCOSE MANUFACTURING
04 1F-18 FLUDEOXYGLUCOSE (MICHIGAN SYNTHESIS)
05 2FLUDEOXYGLUCOSE F-18 INJECTION
01 1China
02 1Israel
03 1U.S.A
04 3Blank
01 2Active
02 4Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13268
Submission : 1998-06-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30323
Submission : 2016-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30031
Submission : 2015-11-16
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9141
Submission : 1991-05-16
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9057
Submission : 1991-04-09
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9250
Submission : 1991-06-19
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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