Details for New Drug Application (NDA): 219146
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NDA 219146 describes GADOBUTROL, which is a drug marketed by Hainan Poly Pharm, Hengrui Pharma, and Zenara, and is included in three NDAs. It is available from two suppliers. Additional details are available on the GADOBUTROL profile page.
The generic ingredient in GADOBUTROL is gadobutrol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the gadobutrol profile page.
The generic ingredient in GADOBUTROL is gadobutrol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the gadobutrol profile page.
Summary for 219146
| Tradename: | GADOBUTROL |
| Applicant: | Zenara |
| 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 8, 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 8, 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 8, 2026 | TE: | AP | RLD: | No | ||||
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