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General MedicationsINTRAVENOUSStandard

XOFIGO

RADIUM RA-223 DICHLORIDE

Standard Dose
162mCi/6ML (27mCi/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview XOFIGO is listed in Drugs@FDA under application 203971 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient RADIUM RA-223 DICHLORIDE Form and strength SOLUTION;INTRAVENOUS - 162mCi/6ML (27mCi/ML) Sponsor BAYER HLTHCARE Submission history Latest submission status date: 2019-12-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview XOFIGO is listed in Drugs@FDA under application 203971 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient RADIUM RA-223 DICHLORIDE Form and strength SOLUTION;INTRAVENOUS - 162mCi/6ML (27mCi/ML) Sponsor BAYER HLTHCARE Submission history Latest submission status date: 2019-12-10 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.