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General MedicationsINTRAVENOUSStandard

LUTATHERA

LUTETIUM LU 177 DOTATATE

Standard Dose
10mCi/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview LUTATHERA is listed in Drugs@FDA under application 208700 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient LUTETIUM LU 177 DOTATATE Form and strength SOLUTION;INTRAVENOUS - 10mCi/ML Sponsor AAA USA INC Submission history Latest submission status date: 2024-11-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview LUTATHERA is listed in Drugs@FDA under application 208700 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LUTETIUM LU 177 DOTATATE Form and strength SOLUTION;INTRAVENOUS - 10mCi/ML Sponsor AAA USA INC Submission history Latest submission status date: 2024-11-26 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.