Last Updated: September 24, 2026

Details for New Drug Application (NDA): 204781


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NDA 204781 describes DOTAREM, which is a drug marketed by Guerbet and is included in one NDA. It is available from one supplier. Additional details are available on the DOTAREM profile page.

The generic ingredient in DOTAREM is gadoterate meglumine. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the gadoterate meglumine profile page.
Summary for 204781
Tradename:DOTAREM
Applicant:Guerbet
Ingredient:gadoterate meglumine
Patents:0
Pharmacology for NDA: 204781
Mechanism of ActionMagnetic Resonance Contrast Activity
Suppliers and Packaging for NDA: 204781
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781 NDA Guerbet LLC 67684-2000 67684-2000-0 10 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL
DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781 NDA Guerbet LLC 67684-2000 67684-2000-1 10 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength37.69GM/100ML (376.9MG/ML)
Approval Date:Mar 20, 2013TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength3.769GM/10ML (376.9MG/ML)
Approval Date:Mar 20, 2013TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5.6535GM/15ML (376.9MG/ML)
Approval Date:Mar 20, 2013TE:APRLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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