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01 13D IMAGING DRUG DESIGN AND DEVELOPMENT LLC
02 1BAMF
03 1Biomedical Research Foundation
04 1Cardinal Health
05 1DECATUR
06 1ESSENTIAL ISOTOPES
07 1Feinstein Institutes
08 1GE Healthcare Inc
09 1Hot Shots Nuclear Medicine
10 1IASON GmbH
11 1ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.
12 1Jubilant DraxImage Inc
13 1KREITCHMAN PET CENTER
14 1MCPRF
15 1MIDWEST MEDICAL ISOTOPES LLC CYCLOTRON DIV
16 1MIPS CRF
17 1NCM USA
18 1National Institutes of Health
19 1Nukemed
20 1PETNET
21 1Precision BioSciences
22 1SHERTECH LABS LLC
23 2Sofie Biosciences
24 1The University of Texas MD Anderson Cancer Center
25 1UCSF RODIOPHARM
26 1UIHC PET IMAGING
27 1UNIV UTAH CYCLOTRON
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01 26INJECTABLE;INTRAVENOUS
02 1SOLUTION
03 1Sodium Fluoride (18F) 2.0 Gbq/Ml 25Ml 1 Units Parenteral Use
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01 8DISCN
02 18RX
03 1Schedule C
04 1Blank
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01 1FLUORINE F-18
02 1Iasonfluoride
03 1NAF PLUS
04 1SODIUM FLUORIDE F 18
05 24SODIUM FLUORIDE F-18
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01 1Canada
02 1Italy
03 26USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2015-10-19
Application Number : 203777
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2015-01-09
Application Number : 204351
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2015-07-30
Application Number : 203780
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 20-600mCi/ML
Packaging :
Approval Date : 2014-11-19
Application Number : 204328
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FLUORINE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 17042
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2015-10-23
Application Number : 203968
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2016-05-19
Application Number : 203936
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-91.5mCi/ML
Packaging :
Approval Date : 2013-06-28
Application Number : 203605
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2015-11-17
Application Number : 204440
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM FLUORIDE F 18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2011-01-26
Application Number : 22494
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2015-04-22
Application Number : 203912
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2015-09-28
Application Number : 203890
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2012-12-26
Application Number : 203544
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2015-08-18
Application Number : 203592
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2013-12-23
Application Number : 203247
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2014-03-13
Application Number : 204437
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2014-09-22
Application Number : 204315
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 : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2015-11-17
Application Number : 204462
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 : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2014-10-21
Application Number : 204464
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 : SODIUM FLUORIDE F-18
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 10-200mCi/ML
Packaging :
Approval Date : 2015-04-20
Application Number : 204497
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF