General MedicationsTOPICALStandard
FILSUVEZ
BIRCH TRITERPENES
Standard Dose
10%
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview FILSUVEZ is listed in Drugs@FDA under application 215064 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient BIRCH TRITERPENES Form and strength GEL;TOPICAL - 10% Sponsor CHIESI Submission history Latest submission status date: 2023-12-18 00:00:00.
Structured Monograph
Clinical summary
Approval overview FILSUVEZ is listed in Drugs@FDA under application 215064 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient BIRCH TRITERPENES Form and strength GEL;TOPICAL - 10% Sponsor CHIESI Submission history Latest submission status date: 2023-12-18 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.