FDA — authorised 14 March 2008
- Application: ANDA077126
- Marketing authorisation holder: SUN PHARM
- Local brand name: AMIFOSTINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Ethyol in United States
FDA authorised Ethyol on 14 March 2008
Marketing authorisations
FDA — authorised 17 July 2017
- Application: ANDA204363
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: AMIFOSTINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Ethyol 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 Ethyol approved in United States?
Yes. FDA authorised it on 14 March 2008; FDA authorised it on 17 July 2017; FDA has authorised it.
Who is the marketing authorisation holder for Ethyol in United States?
SUN PHARM holds the US marketing authorisation.