01 13D IMAGING DRUG DESIGN AND DEVELOPMENT LLC
02 1BAMF
03 1Biomedical Research Foundation
04 1Cardinal Health
05 1DECATUR
06 1ESSENTIAL ISOTOPES
07 1Eckert & Ziegler Strahlen
08 1Feinstein Institutes
09 1GE Healthcare Inc
10 1Hot Shots Nuclear Medicine
11 1IASON GmbH
12 1ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.
13 1Jubilant DraxImage Inc
14 1KREITCHMAN PET CENTER
15 1MCPRF
16 1MIDWEST MEDICAL ISOTOPES LLC CYCLOTRON DIV
17 1MIPS CRF
18 1NCM USA
19 1National Institutes of Health
20 1Nukemed
21 1PETNET
22 1Precision BioSciences
23 1SHERTECH LABS LLC
24 2Sofie Biosciences
25 1The University of Texas MD Anderson Cancer Center
26 1UCSF RODIOPHARM
27 1UIHC PET IMAGING
28 1UNIV UTAH CYCLOTRON
01 26INJECTABLE;INTRAVENOUS
02 1SOLUTION
03 1SOLUTION FOR INJECTION
04 1Sodium Fluoride (18F) 2.0 Gbq/Ml 25Ml 1 Units Parenteral Use
01 8DISCN
02 18RX
03 1Schedule C
04 2Blank
01 1FLUORINE F-18
02 1Iasonfluoride
03 1NAF PLUS
04 1SODIUM FLUORIDE F 18
05 24SODIUM FLUORIDE F-18
06 1Sodium fluoride (F-18), Eckert & Ziegler
01 1Canada
02 1Italy
03 1Sweden
04 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Dosage Strength : 2mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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