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General MedicationsORALStandard

TEMBEXA

BRINCIDOFOVIR

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

Approval overview TEMBEXA is listed in Drugs@FDA under application 214460 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BRINCIDOFOVIR Form and strength SUSPENSION;ORAL - 10MG/ML Sponsor EMERGENT BIODEFENSE Submission history Latest submission status date: 2021-08-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview TEMBEXA is listed in Drugs@FDA under application 214460 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BRINCIDOFOVIR Form and strength SUSPENSION;ORAL - 10MG/ML Sponsor EMERGENT BIODEFENSE Submission history Latest submission status date: 2021-08-03 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.