General MedicationsINTRAVENOUSStandard

GADOBUTROL

Standard Dose

4.5354GM/7.5ML (604.72MG/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: UNKNOWN Marketing status: Prescription

Summary

Approval overview GADOBUTROL is listed in Drugs@FDA under application 217480 (ANDA).

Review priority: UNKNOWN Marketing status: Prescription Active ingredient GADOBUTROL Form and strength SOLUTION;INTRAVENOUS - 4.5354GM/7.5ML (604.72MG/ML) Sponsor HAINAN POLY PHARM Submission history Latest submission status date: 2025-04-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview GADOBUTROL is listed in Drugs@FDA under application 217480 (ANDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient GADOBUTROL Form and strength SOLUTION;INTRAVENOUS - 4.5354GM/7.5ML (604.72MG/ML) Sponsor HAINAN POLY PHARM Submission history Latest submission status date: 2025-04-16 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: UNKNOWN

Interaction Notes

No interaction notes stored yet.