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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 216081


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NDA 216081 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 216081
Tradename:GADOBUTROL
Applicant:Hengrui Pharma
Ingredient:gadobutrol
Patents:0
Pharmacology for NDA: 216081
Mechanism of ActionMagnetic Resonance Contrast Activity
Suppliers and Packaging for NDA: 216081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GADOBUTROL gadobutrol SOLUTION;INTRAVENOUS 216081 ANDA Fresenius Kabi USA, LLC 65219-287 65219-287-30 10 BOTTLE in 1 CARTON (65219-287-30) / 30 mL in 1 BOTTLE (65219-287-10)
GADOBUTROL gadobutrol SOLUTION;INTRAVENOUS 216081 ANDA Fresenius Kabi USA, LLC 65219-289 65219-289-65 10 BOTTLE in 1 CARTON (65219-289-65) / 65 mL in 1 BOTTLE (65219-289-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength18.1416GM/30ML (604.72MG/ML)
Approval Date:Sep 8, 2023TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength39.3068GM/65ML (604.72MG/ML)
Approval Date:Sep 8, 2023TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1.20944GM/2ML (604.72MG/ML)
Approval Date:Nov 17, 2022TE:APRLD:No

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Preferred Citation:

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