Last Updated: August 9, 2026

Details for New Drug Application (NDA): 219287


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NDA 219287 describes GADOBUTROL, which is a drug marketed by Hainan Poly Pharm, Hengrui Pharma, Viwit Pharm, and Zenara, and is included in four NDAs. It is available from four 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. Five suppliers are listed for this compound. Additional details are available on the gadobutrol profile page.
Summary for 219287
Tradename:GADOBUTROL
Applicant:Viwit Pharm
Ingredient:gadobutrol
Patents:0
Pharmacology for NDA: 219287
Mechanism of ActionMagnetic Resonance Contrast Activity
Suppliers and Packaging for NDA: 219287
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GADOBUTROL gadobutrol SOLUTION;INTRAVENOUS 219287 ANDA Viwit Pharmaceutical Co., Ltd. 42337-005 42337-005-02 10 VIAL, SINGLE-DOSE in 1 CARTON (42337-005-02) / 7.5 mL in 1 VIAL, SINGLE-DOSE (42337-005-01)
GADOBUTROL gadobutrol SOLUTION;INTRAVENOUS 219287 ANDA Viwit Pharmaceutical Co., Ltd. 42337-006 42337-006-02 10 VIAL, SINGLE-DOSE in 1 CARTON (42337-006-02) / 10 mL in 1 VIAL, SINGLE-DOSE (42337-006-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength4.5354GM/7.5ML (604.72MG/ML)
Approval Date:Jun 11, 2026TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength6.0472GM/10ML (604.72MG/ML)
Approval Date:Jun 11, 2026TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength9.0708GM/15ML (604.72MG/ML)
Approval Date:Jun 11, 2026TE:APRLD:No

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