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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 217480


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NDA 217480 describes GADOBUTROL, which is a drug marketed by Hainan Poly Pharm and Hengrui Pharma and is included in two 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.
Summary for 217480
Tradename:GADOBUTROL
Applicant:Hainan Poly Pharm
Ingredient:gadobutrol
Patents:0
Pharmacology for NDA: 217480
Mechanism of ActionMagnetic Resonance Contrast Activity
Suppliers and Packaging for NDA: 217480
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GADOBUTROL gadobutrol SOLUTION;INTRAVENOUS 217480 ANDA Slate Run Pharmaceuticals, LLC 70436-212 70436-212-54 20 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-54) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32)
GADOBUTROL gadobutrol SOLUTION;INTRAVENOUS 217480 ANDA Slate Run Pharmaceuticals, LLC 70436-212 70436-212-80 1 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-80) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength4.5354GM/7.5ML (604.72MG/ML)
Approval Date:Mar 15, 2023TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength9.0708GM/15ML (604.72MG/ML)
Approval Date:Mar 15, 2023TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1.20944GM/2ML (604.72MG/ML)
Approval Date:Apr 16, 2025TE:APRLD:No

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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