FDA — authorised 29 March 1982
- Application: NDA018604
- Marketing authorisation holder: BAUSCH
- Local brand name: ZOVIRAX
- Indication: OINTMENT — TOPICAL
- Status: approved
🇺🇸 Acyclovir 5% in United States
FDA authorised Acyclovir 5% on 29 March 1982
Marketing authorisations
FDA — authorised 22 October 1982
- Application: NDA018603
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: ZOVIRAX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 January 1985
- Application: NDA018828
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ZOVIRAX
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 April 1991
- Application: NDA020089
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ZOVIRAX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 2002
- Application: NDA021478
- Marketing authorisation holder: BAUSCH
- Local brand name: ZOVIRAX
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Status: approved
Acyclovir 5% 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 Acyclovir 5% approved in United States?
Yes. FDA authorised it on 29 March 1982; FDA authorised it on 22 October 1982; FDA authorised it on 25 January 1985.
Who is the marketing authorisation holder for Acyclovir 5% in United States?
BAUSCH holds the US marketing authorisation.