Details for New Drug Application (NDA): 215957
NDA 215957 describes PIXXOSCAN, which is a drug marketed by Ge Hlthcare and is included in one NDA. It is available from one supplier. 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. Six 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. Six 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 |
Pharmacology for NDA: 215957
| Mechanism of Action | Magnetic Resonance Contrast Activity |
Suppliers and Packaging for NDA: 215957
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIXXOSCAN | gadobutrol | SOLUTION;INTRAVENOUS | 215957 | ANDA | GE Healthcare Inc. | 0407-1066 | 0407-1066-02 | 10 VIAL, GLASS in 1 BOX (0407-1066-02) / 2 mL in 1 VIAL, GLASS |
| PIXXOSCAN | gadobutrol | SOLUTION;INTRAVENOUS | 215957 | ANDA | GE Healthcare Inc. | 0407-1066 | 0407-1066-08 | 10 VIAL, GLASS in 1 BOX (0407-1066-08) / 7.5 mL in 1 VIAL, GLASS |
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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