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    01 13D IMAGING DRUG DESIGN AND DEVELOPMENT LLC

    02 1BRIGHAM WOMENS HOSP

    03 1Biomedical Research Foundation

    04 1CENTRAL RADIOPHARM

    05 1Cardinal Health

    06 1ESSENTIAL ISOTOPES

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    01

    3D IMAGING DRUG DESIGN AND DEVELOPM...

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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 48.75mCi-487.5mCi/13ML (3.75-37.5mCi/ML)

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    Approval Date : 2015-05-01

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    Approval Date : 2013-02-25

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    ESSENTIAL ISOTOPES

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    AMMONIA N-13

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    Dosage Strength : 3.75mCi-260mCi/ML

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    Approval Date : 2015-12-17

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    Feinstein Institutes

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    AMMONIA N-13

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    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    Approval Date : 2007-08-23

    Application Number : 22119

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    Ionetix

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    AMMONIA N-13

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    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 22.5mCi-225mCi/6ML (3.75-37.5mCi/ML)

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    Approval Date : 2018-12-21

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    KREITCHMAN PET CENTER

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    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    Approval Date : 2013-12-09

    Application Number : 203938

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    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    Approval Date : 2013-02-25

    Application Number : 203321

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    09

    MIDWEST MEDICAL ISOTOPES LLC CYCLOT...

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    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    Approval Date : 2015-11-18

    Application Number : 204457

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    NCM USA

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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 3.75mCi-260mCi/ML

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    Approval Date : 2015-02-04

    Application Number : 204515

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    Registration Country : USA

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    11

    Nukemed

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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    Approval Date : 2015-04-23

    Application Number : 204455

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    Registration Country : USA

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    12

    PETNET

    U.S.A
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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 30mCi-300mCi (3.75-37.5mCi/ML)

    Packaging :

    Approval Date : 2015-11-02

    Application Number : 204510

    Regulatory Info : RX

    Registration Country : USA

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    13

    Precision BioSciences

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    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 3.75mCi-260mCi/ML

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    Approval Date : 2015-08-14

    Application Number : 204547

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    14

    Sofie Biosciences

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    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 3.75mCi-260mCi/ML

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    Approval Date : 2012-12-14

    Application Number : 203543

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    Sofie Biosciences

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    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    Approval Date : 2014-10-23

    Application Number : 204465

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    Sofie Biosciences

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    AMMONIA N-13

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    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 18.8mCi-188mCi/5ML (3.75-37.5mCi/ML)

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    Approval Date : 2015-04-22

    Application Number : 204667

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    17

    The University of Texas MD Anderson...

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    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    Approval Date : 2014-06-27

    Application Number : 203933

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    UCLA

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    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    Approval Date : 2013-06-27

    Application Number : 203812

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    UCSF RODIOPHARM

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    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    Approval Date : 2014-03-28

    Application Number : 204496

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    WA UNIV SCH MED

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    Approval Date : 2014-02-07

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    Wisconsin Medical Cyclotron & Radio...

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    Approval Date : 2014-12-18

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    BRIGHAM WOMENS HOSP

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    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    Approval Date : 2014-10-30

    Application Number : 203783

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    SHERTECH LABS LLC

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    Regulatory Info : DISCN

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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 3.75mCi-260mCi/ML

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    Approval Date : 2014-09-19

    Application Number : 204366

    Regulatory Info : DISCN

    Registration Country : USA

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    JOHNS HOPKINS UNIV

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    Regulatory Info : RX

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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    Approval Date : 2014-08-19

    Application Number : 204514

    Regulatory Info : RX

    Registration Country : USA

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    MIPS CRF

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    Regulatory Info : RX

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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

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    Approval Date : 2014-11-20

    Application Number : 204535

    Regulatory Info : RX

    Registration Country : USA

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    CENTRAL RADIOPHARM

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    Regulatory Info : DISCN

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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 3.75-260mCi/ML

    Packaging :

    Approval Date : 2015-06-23

    Application Number : 204539

    Regulatory Info : DISCN

    Registration Country : USA

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    GEN HOSP

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    Regulatory Info : RX

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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

    Packaging :

    Approval Date : 2016-02-03

    Application Number : 207025

    Regulatory Info : RX

    Registration Country : USA

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    28

    UNIV TX SW MEDCTR

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    Regulatory Info : RX

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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

    Packaging :

    Approval Date : 2019-11-01

    Application Number : 209507

    Regulatory Info : RX

    Registration Country : USA

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    UNIV ALAHAMA BIRM

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    Regulatory Info : RX

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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 15mCi-150mCi/4ML (3.75-37.5mCi/ML)

    Packaging :

    Approval Date : 2022-11-03

    Application Number : 211698

    Regulatory Info : RX

    Registration Country : USA

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    30

    UNIV WISCONSIN

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    Regulatory Info : RX

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    AMMONIA N-13

    Brand Name : AMMONIA N 13

    Dosage Form : INJECTABLE;INTRAVENOUS

    Dosage Strength : 30mCi-300mCi/8ML (3.75-37.5mCi/ML)

    Packaging :

    Approval Date : 2020-09-09

    Application Number : 211740

    Regulatory Info : RX

    Registration Country : USA

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