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Details for New Drug Application (NDA): 204781
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NDA 204781 describes DOTAREM, which is a drug marketed by Guerbet and is included in one NDA. Additional details are available on the DOTAREM profile page.
The generic ingredient in DOTAREM is gadoterate meglumine. Additional details are available on the gadoterate meglumine profile page.
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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