General MedicationsINJECTIONStandard
OMNISCAN
GADODIAMIDE
Standard Dose
287MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview OMNISCAN is listed in Drugs@FDA under application 020123 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient GADODIAMIDE Form and strength INJECTABLE;INJECTION - 287MG/ML Sponsor GE HEALTHCARE Submission history Latest submission status date: 2025-03-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview OMNISCAN is listed in Drugs@FDA under application 020123 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GADODIAMIDE Form and strength INJECTABLE;INJECTION - 287MG/ML Sponsor GE HEALTHCARE 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.