01 13D IMAGING DRUG DESIGN AND DEVELOPMENT LLC
02 1ACOM Srl
03 1ALBERTA HEALTH SERVICES
04 1Advanced Accelerator Applications
05 1BC Cancer
06 1BRIGHAM WOMENS
07 2Biomedical Research Foundation
08 1CHILDRENS HOSP MI
09 1CIUSS DE L'ESTRIE - CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE
10 2Cardinal Health
11 1DECATUR
12 2DOWNSTATE CLINCL
13 1ESSENTIAL ISOTOPES
14 1Eckert & Ziegler Strahlen
15 2Feinstein Institutes
16 7GE Healthcare Inc
17 1Hot Shots Nuclear Medicine
18 2IASON GmbH
19 1IBA PHARMA S.A.
20 1IBA Pharma SA
21 1ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.
22 1Isologic Innovative Radiopharmaceuticals
23 1Jubilant DraxImage Inc
24 1KETTERING MEDCTR
25 1KREITCHMAN PET CENTER
26 1Karolinska University Hospital
27 1Lawson Health Research Institute
28 1MA GENERAL HOSP
29 1MCPRF
30 1METHODIST HOSP RES
31 1MIDWEST MEDICAL ISOTOPES LLC CYCLOTRON DIV
32 1MIPS CRF
33 1Memorial Sloan Kettering Cancer Center
34 1NCM USA
35 1NORTHLAND
36 1NTP Radioisotopes Soc Ltd
37 1Nova Scotia Health Authority
38 1Nuclear medicine, PET Imaging
39 1Nukemed
40 1PETNET
41 2PharmaLogic
42 1Precision BioSciences
43 1QUEEN HAMAMATSU PET
44 1Skåne University Hospital, Lund,
45 2Sofie Biosciences
46 1Sylvia Fedoruk Canadian Centre
47 1THUNDER BAY REGIONAL HEALTH SCIENCES CENTRE
48 1TRUSTEES UNIV PA
49 2The University of Texas MD Anderson Cancer Center
50 1UCLA
51 1UCSF RODIOPHARM
52 1UIHC PET IMAGING
53 1UNIV MICHIGAN
54 1UNIV SOUTHERN CA
55 1UNIV TX SW MEDCTR
56 1UNIV UTAH CYCLOTRON
57 1WUSM CYCLOTRON
58 1Weill Cornell Medicine
59 1Winnipeg Regional Health Authority
60 1Wisconsin Medical Cyclotron & Radiopharmacy
01 1Fluorine-18F-Deoxyglucose 1 Gbq/Ml 11Ml 1 Units Parenteral Use
02 1Fluorine-18F-Deoxyglucose 1 Gbq/Ml 20Ml 1 Units Parenteral Use
03 1Fluorine-18F-Deoxyglucose 185Mbq/Ml 15Ml 1 Units Parenteral Use
04 2Fluorine-18F-Deoxyglucose 250Mbq/Ml 10Ml 1 Units Parenteral Use
05 1Fluorine-18F-Deoxyglucose 600Mbq/Ml 10Ml 1 Units Parenteral Use
06 1INJ
07 2INJECTABLE;INJECTION
08 45INJECTABLE;INTRAVENOUS
09 4Injection fluid, resolution
10 9SOLUTION
11 7SOLUTION FOR INJECTION
01 9DISCN
02 1Originator
03 38RX
04 26Blank
01 118F-FLUDEOXYGLUCOSE (18F-FDG)
02 1ATLANTISCAN
03 1CYCLODX
04 2Efdege
05 1FDG Eckert & Ziegler
06 1FDG IBA
07 2FLUDEOXYGLUCOSE (18F) INJECTION
08 1FLUDEOXYGLUCOSE (F-18)
09 47FLUDEOXYGLUCOSE F18
10 1FLUDEOXYGLUCOSE [F-18] FDG INJECTION
11 1FLUGLUCOSCAN
12 1Fludeoxyglucose (18F) GE Healthcare
13 1Fludeoxyglucose (18F) Karolinska
14 1Fludeoxyglucose (18F) NUS
15 1Fludeoxyglucose (18F) SUS Lund
16 1Fluodeossiglucosio
17 1Glucompet
18 2Gluscan
19 6Steripet
20 1[F-18]-FLUDEOXYGLUCOSE (FDG) INJECTION
01 9Canada
02 6Italy
03 4Norway
04 1South Africa
05 7Sweden
06 47USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-300mCi/ML
Packaging :
Approval Date : 2015-10-30
Application Number : 203778
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-300mCi/ML
Packaging :
Approval Date : 2015-05-01
Application Number : 203710
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-300mCi/ML
Packaging :
Approval Date : 2015-05-01
Application Number : 203837
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-300mCi/ML
Packaging :
Approval Date : 2015-11-13
Application Number : 203603
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-500mCi/ML
Packaging :
Approval Date : 2018-09-27
Application Number : 203603
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2005-08-19
Application Number : 21870
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-400mCi/ML
Packaging :
Approval Date : 2008-11-21
Application Number : 21870
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 4-500mCi/ML
Packaging :
Approval Date : 2014-10-30
Application Number : 203937
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-300mCi/ML
Packaging :
Approval Date : 2015-06-23
Application Number : 203920
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-100mCi/ML
Packaging :
Approval Date : 2016-04-11
Application Number : 203942
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-240mCi/ML
Packaging :
Approval Date : 2013-08-05
Application Number : 203612
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-200mCi/ML
Packaging :
Approval Date : 2015-11-19
Application Number : 203736
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 4-500mCi/ML
Packaging :
Approval Date : 2015-04-22
Application Number : 203911
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-200mCi/ML
Packaging :
Approval Date : 2011-02-25
Application Number : 79086
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-200mCi/ML
Packaging :
Approval Date : 2014-02-04
Application Number : 203664
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-300mCi/ML
Packaging :
Approval Date : 2015-08-31
Application Number : 203591
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-500mCi/ML
Packaging :
Approval Date : 2013-02-14
Application Number : 203665
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-150mCi/ML
Packaging :
Approval Date : 2014-01-13
Application Number : 203246
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-300mCi/ML
Packaging :
Approval Date : 2014-01-13
Application Number : 203246
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 4-40mCi/ML
Packaging :
Approval Date : 2013-06-27
Application Number : 203811
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-300mCi/ML
Packaging :
Approval Date : 2014-05-09
Application Number : 203902
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-100mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2004-08-05
Application Number : 21768
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-500mCi/ML
Packaging :
Approval Date : 2013-10-23
Application Number : 203709
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-300mCi/ML
Packaging :
Approval Date : 2014-02-05
Application Number : 203935
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1994-08-19
Application Number : 20306
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4-90mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2001-09-25
Application Number : 20306
Regulatory Info : DISCN
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-100mCi/ML
Packaging :
Approval Date : 2015-08-31
Application Number : 203771
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-200mCi/ML
Packaging :
Approval Date : 2014-10-29
Application Number : 203801
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-300mCi/ML
Packaging :
Approval Date : 2014-10-30
Application Number : 203816
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
Brand Name : FLUDEOXYGLUCOSE F18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-300mCi/ML
Packaging :
Approval Date : 2015-04-23
Application Number : 203904
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
