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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 210016


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NDA 210016 describes CLARISCAN, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. Additional details are available on the CLARISCAN profile page.

The generic ingredient in CLARISCAN is gadoterate meglumine. Four suppliers are listed for this compound. Additional details are available on the gadoterate meglumine profile page.
Summary for 210016
Tradename:CLARISCAN
Applicant:Ge Healthcare
Ingredient:gadoterate meglumine
Patents:0
Pharmacology for NDA: 210016
Mechanism of ActionMagnetic Resonance Contrast Activity
Suppliers and Packaging for NDA: 210016
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARISCAN gadoterate meglumine SOLUTION;INTRAVENOUS 210016 ANDA GE Healthcare 0407-2943 0407-2943-01 10 VIAL, GLASS in 1 BOX (0407-2943-01) / 10 mL in 1 VIAL, GLASS
CLARISCAN gadoterate meglumine SOLUTION;INTRAVENOUS 210016 ANDA GE Healthcare 0407-2943 0407-2943-02 10 VIAL, GLASS in 1 BOX (0407-2943-02) / 15 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength3.769GM/10ML (376.9MG/ML)
Approval Date:Nov 1, 2019TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5.6535GM/15ML (376.9MG/ML)
Approval Date:Nov 1, 2019TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength7.538GM/20ML (376.9MG/ML)
Approval Date:Nov 1, 2019TE:APRLD:No

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Preferred Citation:

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