FDA — authorised 24 September 1996
- Marketing authorisation holder: DENCO ASSET
- Status: approved
🇺🇸 Denavir in United States
FDA authorised Denavir on 24 September 1996
Marketing authorisations
FDA — authorised 24 September 1996
- Application: NDA020629
- Marketing authorisation holder: MYLAN
- Local brand name: DENAVIR
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 9 November 2022
- Application: ANDA212710
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: PENCICLOVIR
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 7 August 2023
- Application: ANDA216981
- Marketing authorisation holder: TORRENT
- Local brand name: PENCICLOVIR
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 27 September 2024
- Application: ANDA212368
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: PENCICLOVIR
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 22 August 2025
- Application: ANDA214100
- Marketing authorisation holder: AMNEAL
- Local brand name: PENCICLOVIR
- Indication: CREAM — TOPICAL
- Status: approved
Denavir in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Denavir approved in United States?
Yes. FDA authorised it on 24 September 1996; FDA authorised it on 24 September 1996; FDA authorised it on 9 November 2022.
Who is the marketing authorisation holder for Denavir in United States?
DENCO ASSET holds the US marketing authorisation.