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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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PharmaCompass

01

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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02

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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03

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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04

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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05

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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06

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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07

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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08

MCPRF

U.S.A
FNCE
Not Confirmed
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MCPRF

U.S.A
arrow
FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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09

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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10

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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11

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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12

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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13

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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14

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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15

FNCE
Not Confirmed
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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16

FNCE
Not Confirmed
arrow
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FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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17

SHERTECH LABS LLC

Country
FNCE
Not Confirmed
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SHERTECH LABS LLC

Country
arrow
FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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18

UIHC PET IMAGING

Country
FNCE
Not Confirmed
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UIHC PET IMAGING

Country
arrow
FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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19

DECATUR

Country
FNCE
Not Confirmed
arrow

DECATUR

Country
arrow
FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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20

UNIV UTAH CYCLOTRON

Country
FNCE
Not Confirmed
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UNIV UTAH CYCLOTRON

Country
arrow
FNCE
Not Confirmed

SODIUM FLUORIDE F-18

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

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