General MedicationsINJECTIONGeneric
OPTIMARK
GADOVERSETAMIDE
Standard Dose
1654.5MG/5ML (330.9MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview OPTIMARK is listed in Drugs@FDA under application 020937 (NDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient GADOVERSETAMIDE Form and strength INJECTABLE;INJECTION - 1654.5MG/5ML (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 is listed in Drugs@FDA under application 020937 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GADOVERSETAMIDE Form and strength INJECTABLE;INJECTION - 1654.5MG/5ML (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.