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01 5GE HEALTHCARE

02 5GUERBET

03 5HAINAN POLY

04 5HENGRUI PHARMA

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PharmaCompass

01

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : CLARISCAN

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 3.769GM/10ML (376.9MG/ML)

Approval Date : 2019-11-01

Application Number : 210016

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : CLARISCAN

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 5.6535GM/15ML (376.9MG/ML)

Approval Date : 2019-11-01

Application Number : 210016

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : CLARISCAN

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 7.538GM/20ML (376.9MG/ML)

Approval Date : 2019-11-01

Application Number : 210016

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : CLARISCAN

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 37.69GM/100ML (376.9MG/ML)

Approval Date : 2020-08-04

Application Number : 210016

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : CLARISCAN

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1.8845GM/5ML (376.9MG/ML)

Approval Date : 2020-11-24

Application Number : 210016

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : DOTAREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 37.69GM/100ML (376.9MG/ML)

Approval Date : 2013-03-20

Application Number : 204781

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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07

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : DOTAREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 3.769GM/10ML (376.9MG/ML)

Approval Date : 2013-03-20

Application Number : 204781

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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08

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : DOTAREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 5.6535GM/15ML (376.9MG/ML)

Approval Date : 2013-03-20

Application Number : 204781

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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09

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : DOTAREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 7.538GM/20ML (376.9MG/ML)

Approval Date : 2013-03-20

Application Number : 204781

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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10

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : DOTAREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1.8845GM/5ML (376.9MG/ML)

Approval Date : 2017-03-31

Application Number : 204781

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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