FDA — authorised 29 March 1982
- Application: NDA018604
- Marketing authorisation holder: BAUSCH
- Local brand name: ZOVIRAX
- Indication: OINTMENT — TOPICAL
- Status: approved
🇺🇸 Zovirax in United States
FDA authorised Zovirax 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 22 April 1997
- Application: ANDA074556
- Marketing authorisation holder: TEVA
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 April 1997
- Application: ANDA074727
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 April 1997
- Application: ANDA074828
- Marketing authorisation holder: TEVA
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 April 1997
- Application: ANDA074833
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 April 1997
- Application: ANDA074578
- Marketing authorisation holder: TEVA
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 April 1997
- Application: ANDA074836
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 April 1997
- Application: ANDA074872
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 April 1997
- Application: ANDA074674
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 April 1997
- Application: ANDA074834
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 1997
- Application: ANDA074738
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: ACYCLOVIR
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 June 1997
- Application: ANDA074870
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 1997
- Application: ANDA074906
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 October 1997
- Application: ANDA074891
- Marketing authorisation holder: HERITAGE
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 1997
- Application: ANDA074889
- Marketing authorisation holder: HERITAGE
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 November 1997
- Application: ANDA074946
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 November 1997
- Application: ANDA074914
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 March 1998
- Application: ANDA075021
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 1998
- Application: ANDA074976
- Marketing authorisation holder: MYLAN
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 April 1998
- Application: ANDA074977
- Marketing authorisation holder: MYLAN
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 September 1998
- Application: ANDA075211
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 1998
- Application: ANDA074975
- Marketing authorisation holder: RANBAXY
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 September 1998
- Application: ANDA074980
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 January 1999
- Application: ANDA075090
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 April 1999
- Application: ANDA075382
- Marketing authorisation holder: CARLSBAD
- Local brand name: ACYCLOVIR
- 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 — authorised 7 June 2005
- Application: ANDA077026
- Marketing authorisation holder: HIKMA
- Local brand name: ACYCLOVIR
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 28 September 2005
- Application: ANDA075677
- Marketing authorisation holder: APOTEX
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 September 2005
- Application: ANDA077309
- Marketing authorisation holder: APOTEX
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 April 2013
- Application: ANDA202459
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 12 April 2013
- Application: NDA203791
- Marketing authorisation holder: LIGAND PHARMS
- Local brand name: SITAVIG
- Indication: TABLET — BUCCAL
- Status: approved
FDA — authorised 29 October 2013
- Application: ANDA203834
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 November 2013
- Application: ANDA202168
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 June 2014
- Application: ANDA204605
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 31 July 2017
- Application: ANDA205510
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 31 July 2017
- Application: ANDA206437
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 16 August 2017
- Application: ANDA206261
- Marketing authorisation holder: CARLSBAD
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 November 2017
- Application: ANDA205591
- Marketing authorisation holder: COSETTE
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 7 March 2018
- Application: ANDA210401
- Marketing authorisation holder: YILING
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 April 2018
- Application: ANDA209000
- Marketing authorisation holder: ALEMBIC
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 11 January 2019
- Application: ANDA209971
- Marketing authorisation holder: TORRENT
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 18 January 2019
- Application: ANDA211794
- Marketing authorisation holder: CIPLA
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 4 February 2019
- Application: ANDA208702
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: ACYCLOVIR
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 20 February 2019
- Application: ANDA205659
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 15 March 2019
- Application: ANDA205974
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 6 September 2019
- Application: ANDA210774
- Marketing authorisation holder: APOTEX
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 7 October 2019
- Application: ANDA209366
- Marketing authorisation holder: SQUARE PHARMS
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 April 2020
- Application: ANDA212495
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 23 April 2020
- Application: ANDA212718
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ACYCLOVIR
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 10 July 2020
- Application: ANDA212252
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: ACYCLOVIR
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 September 2020
- Application: ANDA212173
- Marketing authorisation holder: YILING
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 November 2020
- Application: ANDA208766
- Marketing authorisation holder: AMNEAL
- Local brand name: ACYCLOVIR
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 11 January 2021
- Application: ANDA213951
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: ACYCLOVIR
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 May 2021
- Application: ANDA212444
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 15 November 2021
- Application: ANDA212202
- Marketing authorisation holder: PRINSTON INC
- Local brand name: ACYCLOVIR
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 31 March 2022
- Application: ANDA216331
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ACYCLOVIR
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 1 July 2022
- Application: ANDA215669
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: ACYCLOVIR
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 August 2022
- Application: ANDA215724
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: ACYCLOVIR
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 28 February 2023
- Application: ANDA206770
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: ACYCLOVIR
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 9 March 2023
- Application: ANDA217393
- Marketing authorisation holder: MSN
- Local brand name: ACYCLOVIR
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 21 November 2023
- Application: ANDA212361
- Marketing authorisation holder: ALEMBIC
- Local brand name: ACYCLOVIR
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 2 May 2025
- Application: ANDA212981
- Marketing authorisation holder: CIPLA
- Local brand name: ACYCLOVIR
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA074658
- Marketing authorisation holder: LEK PHARM
- Local brand name: ACYCLOVIR
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA074750
- Marketing authorisation holder: LEK PHARM
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA074570
- Marketing authorisation holder: ROXANE
- Local brand name: ACYCLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
Zovirax 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 Zovirax 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 Zovirax in United States?
BAUSCH holds the US marketing authorisation.