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Approved Drug Products containing Ammonia N 13 listed in the FDA Orange Book. Original Data : FDA Website

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01 13D IMAGING DRUG

02 1BIOMEDCL RES FDN

03 1BRIGHAM WOMENS HOSP

04 1CARDINAL HLTH 414

05 1CENTRAL RADIOPHARM

06 1DECATUR

07 1ESSENTIAL ISOTOPES

08 1FEINSTEIN

09 1GEN HOSP

10 1IONETIX

11 1JOHNS HOPKINS UNIV

12 1KREITCHMAN PET CTR

13 1MCPRF

14 1METHODIST

15 1MIDWEST MEDCL

16 1MIPS CRF

17 1NCM USA BRONX LLC

18 1NUKEMED

19 1PETNET

20 1PRECISION NUCLEAR

21 1SHERTECH LABS LLC

22 2SOFIE

23 1UCLA BIOMEDICAL

24 1UCSF RODIOPHARM

25 1UNIV ALAHAMA BIRM

26 1UNIV TX MD ANDERSON

27 1UNIV TX SW MEDCTR

28 1UNIV WISCONSIN

29 1WA UNIV SCH MED

30 1WISCONSIN

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01

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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)

Approval Date : 2015-10-19

Application Number : 203779

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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02

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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)

Approval Date : 2015-05-01

Application Number : 204352

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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03

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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)

Approval Date : 2013-02-25

Application Number : 203700

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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04

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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)

Approval Date : 2007-08-23

Application Number : 22119

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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05

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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)

Approval Date : 2013-12-09

Application Number : 203938

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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06

MCPRF

U.S.A
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MCPRF

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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)

Approval Date : 2013-02-25

Application Number : 203321

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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07

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AMMONIA N-13

Brand Name : AMMONIA N 13

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 3.75mCi-260mCi/ML

Approval Date : 2012-12-14

Application Number : 203543

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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08

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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)

Approval Date : 2014-06-27

Application Number : 203933

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

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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)

Approval Date : 2013-06-27

Application Number : 203812

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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10

BRIGHAM WOMENS HOSP

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BRIGHAM WOMENS HOSP

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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)

Approval Date : 2014-10-30

Application Number : 203783

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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