General MedicationsINJECTIONGeneric

OPTIMARK IN PLASTIC CONTAINER

GADOVERSETAMIDE

Standard Dose

4963.5MG/15ML (330.9MG/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview OPTIMARK IN PLASTIC CONTAINER is listed in Drugs@FDA under application 020976 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient GADOVERSETAMIDE Form and strength INJECTABLE;INJECTION - 4963.5MG/15ML (330.9MG/ML) Sponsor LIEBEL-FLARSHEIM Submission history Latest submission status date: 2018-11-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview OPTIMARK IN PLASTIC CONTAINER is listed in Drugs@FDA under application 020976 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GADOVERSETAMIDE Form and strength INJECTABLE;INJECTION - 4963.5MG/15ML (330.9MG/ML) Sponsor LIEBEL-FLARSHEIM Submission history Latest submission status date: 2018-11-02 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.