FDA — authorised 22 April 1997
- Application: ANDA074720
- Marketing authorisation holder: HOSPIRA
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 ACYCLOVIR SODIUM in United States
FDA authorised ACYCLOVIR SODIUM on 22 April 1997
Marketing authorisations
FDA — authorised 22 April 1997
- Application: ANDA074663
- Marketing authorisation holder: HOSPIRA
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 April 1997
- Application: ANDA074758
- Marketing authorisation holder: HOSPIRA
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 April 1997
- Application: ANDA074596
- Marketing authorisation holder: CHARTWELL INJECTABLE
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 August 1997
- Application: ANDA074969
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 October 1997
- Application: ANDA074913
- Marketing authorisation holder: EUROHLTH INTL SARL
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 December 1997
- Application: ANDA074897
- Marketing authorisation holder: APOTHECON
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 December 1997
- Application: ANDA074885
- Marketing authorisation holder: EUROHLTH INTL SARL
- Local brand name: ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 April 1998
- Application: ANDA075015
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 May 1998
- Application: ANDA074930
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 February 1999
- Application: ANDA075065
- Marketing authorisation holder: HOSPIRA
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 March 2001
- Application: ANDA075627
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 October 2013
- Application: ANDA203701
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 February 2016
- Application: ANDA205771
- Marketing authorisation holder: HIKMA
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 March 2017
- Application: ANDA203927
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 2018
- Application: ANDA206535
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 June 2020
- Application: ANDA207919
- Marketing authorisation holder: DR REDDYS
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 June 2024
- Application: ANDA215404
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ACYCLOVIR SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
ACYCLOVIR SODIUM 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 SODIUM approved in United States?
Yes. FDA authorised it on 22 April 1997; FDA authorised it on 22 April 1997; FDA authorised it on 22 April 1997.
Who is the marketing authorisation holder for ACYCLOVIR SODIUM in United States?
HOSPIRA holds the US marketing authorisation.