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01 7AXIM
02 2Farmak JSC
03 9GE Healthcare Inc
04 26GUERBET
05 6Hainan Poly Pharm
06 5Jiangsu Hengrui Medicine
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01 12INJ
02 1Injection
03 8Injection fluid, resolution
04 10PFS
05 1Prefilled Syringe
06 1SOLUTION
07 20SOLUTION;INTRAVENOUS
08 1Solution for Injection
09 1VIA
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01 1Ethical
02 4Generic
03 19Originator
04 20RX
05 11Blank
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01 9CLARISCAN
02 6DOTAREM
03 8Dotarem
04 4Dotarem 10Ml
05 4Dotarem 15Ml
06 4Dotarem 20Ml
07 7Dotarem Prefilled Syringes
08 1Dotavist
09 10GADOTERATE MEGLUMINE
10 1Product Under Development
11 1Blank
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01 1Canada
02 1China
03 8Norway
04 23South Africa
05 20USA
06 2Ukraine
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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 : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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 : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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 : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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 : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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 : RX
Registration Country : USA