General MedicationsTOPICALStandard
ZELSUVMI
BERDAZIMER SODIUM
Standard Dose
EQ 10.3% BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ZELSUVMI is listed in Drugs@FDA under application 217424 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient BERDAZIMER SODIUM Form and strength GEL;TOPICAL - EQ 10.3% BASE Sponsor LNHC Submission history Latest submission status date: 2024-01-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview ZELSUVMI is listed in Drugs@FDA under application 217424 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BERDAZIMER SODIUM Form and strength GEL;TOPICAL - EQ 10.3% BASE Sponsor LNHC Submission history Latest submission status date: 2024-01-05 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.