FDA — authorised 23 May 2018
- Application: ANDA206164
- Marketing authorisation holder: ENCUBE
- Status: approved
🇺🇸 Benzoyl Peroxide gel in United States
FDA authorised Benzoyl Peroxide gel on 23 May 2018
Marketing authorisations
FDA — authorised 25 May 2018
- Application: ANDA208776
- Marketing authorisation holder: SUN PHARMA CANADA
- Status: approved
Benzoyl Peroxide gel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Benzoyl Peroxide gel approved in United States?
Yes. FDA authorised it on 23 May 2018; FDA authorised it on 25 May 2018.
Who is the marketing authorisation holder for Benzoyl Peroxide gel in United States?
ENCUBE holds the US marketing authorisation.