Details for New Drug Application (NDA): 215061
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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 215061
Tradename: | GADOBUTROL |
Applicant: | Hengrui Pharma |
Ingredient: | gadobutrol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215061
Mechanism of Action | Magnetic Resonance Contrast Activity |
Suppliers and Packaging for NDA: 215061
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 215061 | ANDA | Fresenius Kabi USA, LLC | 65219-281 | 65219-281-02 | 5 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00) |
GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 215061 | ANDA | Fresenius Kabi USA, LLC | 65219-281 | 65219-281-07 | 2 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1.20944GM/2ML (604.72MG/ML) | ||||
Approval Date: | Nov 17, 2022 | 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: | Nov 17, 2022 | 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: | Nov 17, 2022 | TE: | AP | RLD: | No |
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