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General MedicationsORALStandard

SOVALDI

SOFOSBUVIR

Standard Dose
200MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SOVALDI is listed in Drugs@FDA under application 204671 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SOFOSBUVIR Form and strength TABLET;ORAL - 200MG Sponsor GILEAD SCIENCES INC Submission history Latest submission status date: 2024-12-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview SOVALDI is listed in Drugs@FDA under application 204671 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SOFOSBUVIR Form and strength TABLET;ORAL - 200MG Sponsor GILEAD SCIENCES INC Submission history Latest submission status date: 2024-12-23 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.