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General MedicationsINJECTIONStandard

MEGATOPE

ALBUMIN IODINATED I-131 SERUM

Standard Dose
0.5mCi/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview MEGATOPE is listed in Drugs@FDA under application 017837 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ALBUMIN IODINATED I-131 SERUM Form and strength INJECTABLE;INJECTION - 0.5mCi/VIAL Sponsor ISO TEX Submission history Latest submission status date: 2023-08-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview MEGATOPE is listed in Drugs@FDA under application 017837 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ALBUMIN IODINATED I-131 SERUM Form and strength INJECTABLE;INJECTION - 0.5mCi/VIAL Sponsor ISO TEX Submission history Latest submission status date: 2023-08-25 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.