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General MedicationsINTRAVESICALStandard

VALRUBICIN

VALRUBICIN

Standard Dose
40MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview VALRUBICIN is listed in Drugs@FDA under application 206430 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient VALRUBICIN Form and strength SOLUTION;INTRAVESICAL - 40MG/ML Sponsor HIKMA Submission history Latest submission status date: 2019-04-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview VALRUBICIN is listed in Drugs@FDA under application 206430 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient VALRUBICIN Form and strength SOLUTION;INTRAVESICAL - 40MG/ML Sponsor HIKMA Submission history Latest submission status date: 2019-04-19 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.