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General MedicationsORALStandard

HARVONI

LEDIPASVIR; SOFOSBUVIR

Standard Dose
45MG;200MG/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview HARVONI is listed in Drugs@FDA under application 212477 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient LEDIPASVIR; SOFOSBUVIR Form and strength PELLETS;ORAL - 45MG;200MG/PACKET Sponsor GILEAD SCIENCES INC Submission history Latest submission status date: 2024-12-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview HARVONI is listed in Drugs@FDA under application 212477 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LEDIPASVIR; SOFOSBUVIR Form and strength PELLETS;ORAL - 45MG;200MG/PACKET Sponsor GILEAD SCIENCES INC Submission history Latest submission status date: 2024-12-19 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.