FDA — authorised 23 September 1969
- Status: approved
🇺🇸 Zonalon in United States
FDA authorised Zonalon on 23 September 1969
Marketing authorisations
FDA — authorised 1 April 1994
- Application: NDA020126
- Marketing authorisation holder: MYLAN
- Local brand name: ZONALON
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 22 December 2016
- Application: NDA022036
- Marketing authorisation holder: CURRAX
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 12 November 2021
- Application: ANDA202337
- Marketing authorisation holder: RK PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 17 February 2023
- Application: ANDA215408
- Marketing authorisation holder: TEVA PHARMS
- Status: approved
FDA — authorised 21 August 2023
- Application: ANDA217975
- Marketing authorisation holder: UNIQUE
- Status: approved
FDA — authorised 6 August 2025
- Application: ANDA219058
- Marketing authorisation holder: TARO
- Status: approved
Zonalon in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Zonalon approved in United States?
Yes. FDA authorised it on 23 September 1969; FDA authorised it on 1 April 1994; FDA authorised it on 22 December 2016.
Who is the marketing authorisation holder for Zonalon in United States?
Marketing authorisation holder not available in our data.