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Details for New Drug Application (NDA): 204781
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The generic ingredient in DOTAREM is gadoterate meglumine. Additional details are available on the gadoterate meglumine profile page.
Summary for 204781
Tradename: | DOTAREM |
Applicant: | Guerbet |
Ingredient: | gadoterate meglumine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 37.69GM/100ML (376.9MG/ML) | ||||
Approval Date: | Mar 20, 2013 | TE: | AP | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Aug 25, 2020 | ||||||||
Regulatory Exclusivity Use: |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 3.769GM/10ML (376.9MG/ML) | ||||
Approval Date: | Mar 20, 2013 | TE: | AP | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Aug 25, 2020 | ||||||||
Regulatory Exclusivity Use: |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5.6535GM/15ML (376.9MG/ML) | ||||
Approval Date: | Mar 20, 2013 | TE: | AP | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Aug 25, 2020 | ||||||||
Regulatory Exclusivity Use: |
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