General MedicationsINTRAVENOUSStandard

GADOTERATE MEGLUMINE

Standard Dose

37.69GM/100ML (376.9MG/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview GADOTERATE MEGLUMINE is listed in Drugs@FDA under application 218073 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GADOTERATE MEGLUMINE Form and strength SOLUTION;INTRAVENOUS - 37.69GM/100ML (376.9MG/ML) Sponsor HAINAN POLY Submission history Latest submission status date: 2024-06-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview GADOTERATE MEGLUMINE is listed in Drugs@FDA under application 218073 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GADOTERATE MEGLUMINE Form and strength SOLUTION;INTRAVENOUS - 37.69GM/100ML (376.9MG/ML) Sponsor HAINAN POLY Submission history Latest submission status date: 2024-06-17 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.