General MedicationsORALStandard
SOVALDI
SOFOSBUVIR
Standard Dose
200MG/PACKET
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 212480 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient SOFOSBUVIR Form and strength PELLETS;ORAL - 200MG/PACKET 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 212480 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SOFOSBUVIR Form and strength PELLETS;ORAL - 200MG/PACKET 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.