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General MedicationsINJECTIONGeneric

OMNISCAN

GADODIAMIDE

Standard Dose
14.35GM/50ML (287MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview OMNISCAN is listed in Drugs@FDA under application 022066 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient GADODIAMIDE Form and strength INJECTABLE;INJECTION - 14.35GM/50ML (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 022066 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GADODIAMIDE Form and strength INJECTABLE;INJECTION - 14.35GM/50ML (287MG/ML) Sponsor GE HEALTHCARE Submission history Latest submission status date: 2025-03-05 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.