Last Updated: September 24, 2026

Details for New Drug Application (NDA): 215304


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NDA 215304 describes GADOTERATE MEGLUMINE, which is a drug marketed by Hainan Poly, Hengrui Pharma, and Viwit Pharm, and is included in three 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. 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 215304
Tradename:GADOTERATE MEGLUMINE
Applicant:Hengrui Pharma
Ingredient:gadoterate meglumine
Patents:0
Pharmacology for NDA: 215304
Mechanism of ActionMagnetic Resonance Contrast Activity
Suppliers and Packaging for NDA: 215304
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GADOTERATE MEGLUMINE gadoterate meglumine SOLUTION;INTRAVENOUS 215304 ANDA Fresenius Kabi USA, LLC 65219-080 65219-080-05 10 CARTON in 1 BOX (65219-080-05) / 1 VIAL in 1 CARTON (65219-080-01) / 5 mL in 1 VIAL
GADOTERATE MEGLUMINE gadoterate meglumine SOLUTION;INTRAVENOUS 215304 ANDA Fresenius Kabi USA, LLC 65219-082 65219-082-10 10 CARTON in 1 BOX (65219-082-10) / 1 VIAL in 1 CARTON (65219-082-01) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength1.8845GM/5ML (376.9MG/ML)
Approval Date:Apr 11, 2022TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength3.769GM/10ML (376.9MG/ML)
Approval Date:Apr 11, 2022TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength5.6535GM/15ML (376.9MG/ML)
Approval Date:Apr 11, 2022TE:RLD:No

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