General MedicationsINTRAVENOUSStandard
GADOBUTROL
GADOBUTROL
Standard Dose
9.0708GM/15ML (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 - 9.0708GM/15ML (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 - 9.0708GM/15ML (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.