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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. It is available from one supplier. Additional details are available on the DOTAREM profile page.
The generic ingredient in DOTAREM is gadoterate meglumine. Two suppliers are listed for this compound. Additional details are available on the gadoterate meglumine profile page.
The generic ingredient in DOTAREM is gadoterate meglumine. Two suppliers are listed for this compound. 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 |
Pharmacology for NDA: 204781
| Mechanism of Action | Magnetic Resonance Contrast Activity |
Suppliers and Packaging for NDA: 204781
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781 | NDA | Guerbet LLC | 67684-2000 | 67684-2000-0 | 10 VIAL in 1 PACKAGE (67684-2000-0) > 5 mL in 1 VIAL |
| DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781 | NDA | Guerbet LLC | 67684-2000 | 67684-2000-1 | 10 VIAL in 1 PACKAGE (67684-2000-1) > 10 mL in 1 VIAL |
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: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 25, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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: | NEW PATIENT POPULATION | ||||||||
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: | NEW PATIENT POPULATION | ||||||||
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