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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 218073


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NDA 218073 describes GADOTERATE MEGLUMINE, which is a drug marketed by Hainan Poly and Hengrui Pharma and is included in two NDAs. It is available from two suppliers. Additional details are available on the GADOTERATE MEGLUMINE profile page.

The generic ingredient in GADOTERATE MEGLUMINE is gadoterate meglumine. Four suppliers are listed for this compound. Additional details are available on the gadoterate meglumine profile page.
Summary for 218073
Tradename:GADOTERATE MEGLUMINE
Applicant:Hainan Poly
Ingredient:gadoterate meglumine
Patents:0
Pharmacology for NDA: 218073
Mechanism of ActionMagnetic Resonance Contrast Activity
Suppliers and Packaging for NDA: 218073
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GADOTERATE MEGLUMINE gadoterate meglumine SOLUTION;INTRAVENOUS 218073 ANDA Slate Run Pharmaceuticals, LLC 70436-123 70436-123-31 10 VIAL in 1 CARTON (70436-123-31) / 5 mL in 1 VIAL
GADOTERATE MEGLUMINE gadoterate meglumine SOLUTION;INTRAVENOUS 218073 ANDA Slate Run Pharmaceuticals, LLC 70436-123 70436-123-33 10 VIAL in 1 CARTON (70436-123-33) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength1.8845GM/5ML (376.9MG/ML)
Approval Date:Jun 17, 2024TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength3.769GM/10ML (376.9MG/ML)
Approval Date:Jun 17, 2024TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength5.6535GM/15ML (376.9MG/ML)
Approval Date:Jun 17, 2024TE:APRLD:No

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Preferred Citation:

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