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01 2Farmak JSC

02 5GE Healthcare Inc

03 6GUERBET

04 6Hainan Poly Pharm

05 5Jiangsu Hengrui Medicine

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PharmaCompass

01

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : CLARISCAN

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2019-11-01

Application Number : 210016

Regulatory Info : RX

Registration Country : USA

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02

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : CLARISCAN

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2019-11-01

Application Number : 210016

Regulatory Info : RX

Registration Country : USA

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03

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : CLARISCAN

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2019-11-01

Application Number : 210016

Regulatory Info : RX

Registration Country : USA

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04

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : CLARISCAN

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2020-08-04

Application Number : 210016

Regulatory Info : RX

Registration Country : USA

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05

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : CLARISCAN

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2020-11-24

Application Number : 210016

Regulatory Info : RX

Registration Country : USA

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06

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : DOTAREM

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2013-03-20

Application Number : 204781

Regulatory Info : RX

Registration Country : USA

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07

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : DOTAREM

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2013-03-20

Application Number : 204781

Regulatory Info : RX

Registration Country : USA

blank

08

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : DOTAREM

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2013-03-20

Application Number : 204781

Regulatory Info : RX

Registration Country : USA

blank

09

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : DOTAREM

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2013-03-20

Application Number : 204781

Regulatory Info : RX

Registration Country : USA

blank

10

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : DOTAREM

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2017-03-31

Application Number : 204781

Regulatory Info : RX

Registration Country : USA

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11

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : GADOTERATE MEGLUMINE

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2024-06-17

Application Number : 218073

Regulatory Info : RX

Registration Country : USA

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12

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : GADOTERATE MEGLUMINE

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2024-06-17

Application Number : 218073

Regulatory Info : RX

Registration Country : USA

blank

13

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : GADOTERATE MEGLUMINE

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2024-06-17

Application Number : 218073

Regulatory Info : RX

Registration Country : USA

blank

14

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : GADOTERATE MEGLUMINE

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2024-06-17

Application Number : 218073

Regulatory Info : RX

Registration Country : USA

blank

15

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : GADOTERATE MEGLUMINE

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2024-06-17

Application Number : 218073

Regulatory Info : RX

Registration Country : USA

blank

16

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : GADOTERATE MEGLUMINE

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2022-04-11

Application Number : 215304

Regulatory Info : DISCN

Registration Country : USA

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17

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : GADOTERATE MEGLUMINE

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2022-04-11

Application Number : 215304

Regulatory Info : DISCN

Registration Country : USA

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18

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : GADOTERATE MEGLUMINE

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2022-04-11

Application Number : 215304

Regulatory Info : DISCN

Registration Country : USA

blank

19

CPhI Japan
Not Confirmed
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : GADOTERATE MEGLUMINE

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2022-04-11

Application Number : 215304

Regulatory Info : DISCN

Registration Country : USA

blank

20

CPhI Japan
Not Confirmed
arrow
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CPhI Japan
Not Confirmed

GADOTERATE MEGLUMINE

Brand Name : GADOTERATE MEGLUMINE

Dosage Form : SOLUTION;INTRAVENOUS

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

Packaging :

Approval Date : 2022-04-15

Application Number : 215304

Regulatory Info : DISCN

Registration Country : USA

blank