General MedicationsTOPICALStandard
EPSOLAY
BENZOYL PEROXIDE
Standard Dose
5%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview EPSOLAY is listed in Drugs@FDA under application 214510 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient BENZOYL PEROXIDE Form and strength CREAM;TOPICAL - 5% Sponsor MAYNE PHARMA Submission history Latest submission status date: 2022-04-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview EPSOLAY is listed in Drugs@FDA under application 214510 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BENZOYL PEROXIDE Form and strength CREAM;TOPICAL - 5% Sponsor MAYNE PHARMA Submission history Latest submission status date: 2022-04-22 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.