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01 13D IMAGING DRUG DESIGN AND DEVELOPMENT LLC
02 1ACOM Srl
03 1ALBERTA HEALTH SERVICES
04 1Advanced Accelerator Applications
05 1BAMF
06 1BC Cancer
07 1BRIGHAM WOMENS
08 2Biomedical Research Foundation
09 1CHILDRENS HOSP MI
10 1CIUSS DE L'ESTRIE - CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE
11 2Cardinal Health
12 1DECATUR
13 2DOWNSTATE CLINCL
14 1ESSENTIAL ISOTOPES
15 1Eckert & Ziegler Strahlen
16 2Feinstein Institutes
17 7GE Healthcare Inc
18 1Hot Shots Nuclear Medicine
19 2IASON GmbH
20 1IBA PHARMA S.A.
21 1IBA Pharma SA
22 1ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.
23 1Isologic Innovative Radiopharmaceuticals
24 1Jubilant DraxImage Inc
25 1KETTERING MEDCTR
26 1KREITCHMAN PET CENTER
27 1Karolinska University Hospital
28 1Lawson Health Research Institute
29 1MA GENERAL HOSP
30 1MCPRF
31 1METHODIST HOSP RES
32 1MIDWEST MEDICAL ISOTOPES LLC CYCLOTRON DIV
33 1MIPS CRF
34 1Memorial Sloan Kettering Cancer Center
35 1NCM USA
36 1NORTHLAND
37 1NTP Radioisotopes Soc Ltd
38 1Nova Scotia Health Authority
39 1Nuclear medicine, PET Imaging
40 1Nukemed
41 1PETNET
42 2PharmaLogic
43 1Precision BioSciences
44 1QUEEN HAMAMATSU PET
45 1SHARED HEALTH
46 1Skåne University Hospital, Lund,
47 2Sofie Biosciences
48 1Sylvia Fedoruk Canadian Centre
49 1THUNDER BAY REGIONAL HEALTH SCIENCES CENTRE
50 1TRUSTEES UNIV PA
51 2The University of Texas MD Anderson Cancer Center
52 1UCLA
53 1UCSF RODIOPHARM
54 1UIHC PET IMAGING
55 1UNIV MICHIGAN
56 1UNIV SOUTHERN CA
57 1UNIV TX SW MEDCTR
58 1UNIV UTAH CYCLOTRON
59 1WUSM CYCLOTRON
60 1Weill Cornell Medicine
61 1Wisconsin Medical Cyclotron & Radiopharmacy
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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 46INJECTABLE;INTRAVENOUS
09 4Injection fluid, resolution
10 9SOLUTION
11 7SOLUTION FOR INJECTION
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01 9DISCN
02 1Originator
03 39RX
04 9Schedule C
05 17Blank
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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 48FLUDEOXYGLUCOSE 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
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01 9Canada
02 6Italy
03 4Norway
04 1South Africa
05 7Sweden
06 48USA
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