01 7AXIM
02 2Farmak JSC
03 17GE Healthcare Inc
04 35GUERBET
05 6Hainan Poly Pharm
06 5Jiangsu Hengrui Medicine
07 5beimaging.ag
01 12INJ
02 4Inj L?s
03 8Inj Loose
04 5Inj. L?s
05 2Inj. Soluble
06 2Inj. Solution
07 1Injection
08 8Injection fluid, resolution
09 10PFS
10 1Prefilled Syringe
11 1SOLUTION
12 1SOLUTION FOR INJECTION
13 20SOLUTION;INTRAVENOUS
14 1Solution for Injection
15 1VIA
01 1Ethical
02 4Generic
03 19Originator
04 20RX
05 33Blank
01 1Artirem
02 9CLARISCAN
03 8Clariscan
04 5Cyclolux
05 6DOTAREM
06 16Dotarem
07 4Dotarem 10Ml
08 4Dotarem 15Ml
09 4Dotarem 20Ml
10 7Dotarem Prefilled Syringes
11 1Dotavist
12 10GADOTERATE MEGLUMINE
13 1Product Under Development
14 1Blank
01 1Canada
02 1China
03 8Norway
04 23South Africa
05 1Sweden
06 21Switzerland
07 20USA
08 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
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