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General MedicationsINTRAVENOUSStandard

GADOTERATE MEGLUMINE

GADOTERATE MEGLUMINE

Standard Dose
1.8845GM/5ML (376.9MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription

Key Takeaways

  • Primary indication: Review priority: STANDARD Marketing status: Prescription
  • 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 - 1.8845GM/5ML (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 - 1.8845GM/5ML (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.