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General MedicationsINTRAVENOUSGeneric

VIZAMYL

FLUTEMETAMOL F-18

Standard Dose
40.5mCi/10ML (4.05mCi/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview VIZAMYL is listed in Drugs@FDA under application 203137 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient FLUTEMETAMOL F-18 Form and strength INJECTABLE;INTRAVENOUS - 40.5mCi/10ML (4.05mCi/ML) Sponsor GE HEALTHCARE Submission history Latest submission status date: 2025-06-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview VIZAMYL is listed in Drugs@FDA under application 203137 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient FLUTEMETAMOL F-18 Form and strength INJECTABLE;INTRAVENOUS - 40.5mCi/10ML (4.05mCi/ML) Sponsor GE HEALTHCARE Submission history Latest submission status date: 2025-06-23 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.