Details for New Drug Application (NDA): 215957
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NDA 215957 describes PIXXOSCAN, which is a drug marketed by Ge Hlthcare and is included in one NDA. Additional details are available on the PIXXOSCAN profile page.
The generic ingredient in PIXXOSCAN is gadobutrol. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the gadobutrol profile page.
The generic ingredient in PIXXOSCAN is gadobutrol. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the gadobutrol profile page.
Summary for 215957
| Tradename: | PIXXOSCAN |
| Applicant: | Ge Hlthcare |
| Ingredient: | gadobutrol |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1.20944GM/2ML (604.72MG/ML) | ||||
| Approval Date: | Jun 29, 2026 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 4.5354GM/7.5ML (604.72MG/ML) | ||||
| Approval Date: | Jun 29, 2026 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 6.0472GM/10ML (604.72MG/ML) | ||||
| Approval Date: | Jun 29, 2026 | TE: | AP | RLD: | No | ||||
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