FDA — authorised 27 January 1989
- Status: approved
🇺🇸 Eulexin in United States
FDA authorised Eulexin on 27 January 1989
Marketing authorisations
FDA — authorised 27 January 1989
- Application: NDA018554
- Marketing authorisation holder: SCHERING
- Local brand name: EULEXIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 September 2001
- Application: ANDA075298
- Marketing authorisation holder: WAYLIS THERAP
- Status: approved
Eulexin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Eulexin approved in United States?
Yes. FDA authorised it on 27 January 1989; FDA authorised it on 27 January 1989; FDA authorised it on 18 September 2001.
Who is the marketing authorisation holder for Eulexin in United States?
Pfizer Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.