General MedicationsINTRAVENOUSStandard
EOVIST
GADOXETATE DISODIUM
Standard Dose
1.8143GM/10ML (181.43MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview EOVIST is listed in Drugs@FDA under application 022090 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient GADOXETATE DISODIUM Form and strength SOLUTION;INTRAVENOUS - 1.8143GM/10ML (181.43MG/ML) Sponsor BAYER HLTHCARE Submission history Latest submission status date: 2026-02-13 00:00:00.
Structured Monograph
Clinical summary
Approval overview EOVIST is listed in Drugs@FDA under application 022090 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GADOXETATE DISODIUM Form and strength SOLUTION;INTRAVENOUS - 1.8143GM/10ML (181.43MG/ML) Sponsor BAYER HLTHCARE Submission history Latest submission status date: 2026-02-13 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.