U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 214510

Marketing Status: Prescription
Active Ingredient: BENZOYL PEROXIDE
Proprietary Name: EPSOLAY
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 5%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214510
Product Number: 001
Approval Date: Apr 22, 2022
Applicant Holder Full Name: GALDERMA LABORATORIES LP
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top