General MedicationsINTRAVENOUSStandard
MULTIHANCE
GADOBENATE DIMEGLUMINE
Standard Dose
7.935GM/15ML (529MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview MULTIHANCE is listed in Drugs@FDA under application 021357 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient GADOBENATE DIMEGLUMINE Form and strength INJECTABLE;INTRAVENOUS - 7.935GM/15ML (529MG/ML) Sponsor BRACCO Submission history Latest submission status date: 2025-03-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview MULTIHANCE is listed in Drugs@FDA under application 021357 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GADOBENATE DIMEGLUMINE Form and strength INJECTABLE;INTRAVENOUS - 7.935GM/15ML (529MG/ML) Sponsor BRACCO Submission history Latest submission status date: 2025-03-05 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.