FDA — authorised 23 June 1989
- Application: NDA019661
- Marketing authorisation holder: CHEPLAPHARM
- Local brand name: CYTOVENE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Cytovene in United States
FDA authorised Cytovene on 23 June 1989
Marketing authorisations
FDA — authorised 23 June 1989
- Marketing authorisation holder: ROCHE PALO
- Status: approved
FDA — authorised 22 December 1994
- Application: NDA020460
- Marketing authorisation holder: ROCHE PALO
- Local brand name: CYTOVENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 March 1996
- Application: NDA020569
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: VITRASERT
- Indication: IMPLANT — IMPLANTATION
- Status: approved
FDA — authorised 29 April 2014
- Application: NDA022211
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 6 December 2016
- Application: ANDA204950
- Marketing authorisation holder: PH HEALTH
- Status: approved
FDA — authorised 17 February 2017
- Application: NDA209347
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: GANZYK-RTU
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 8 November 2018
- Application: ANDA204204
- Marketing authorisation holder: SLATE RUN PHARMA
- Status: approved
FDA — authorised 18 May 2020
- Application: ANDA207645
- Marketing authorisation holder: PHARMASCIENCE INC
- Indication: Labeling
- Status: approved
FDA — authorised 8 June 2020
- Application: ANDA090658
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA
- Application: ANDA076457
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: GANCICLOVIR
- Indication: CAPSULE — ORAL
- Status: approved
Cytovene 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 Cytovene approved in United States?
Yes. FDA authorised it on 23 June 1989; FDA authorised it on 23 June 1989; FDA authorised it on 22 December 1994.
Who is the marketing authorisation holder for Cytovene in United States?
CHEPLAPHARM holds the US marketing authorisation.