FDA — authorised 28 November 1990
- Application: NDA019879
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: ORNIDYL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 EFLORNITHINE HYDROCHLORIDE in United States
FDA authorised EFLORNITHINE HYDROCHLORIDE on 28 November 1990
Marketing authorisations
FDA
- Status: approved
EFLORNITHINE HYDROCHLORIDE 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 EFLORNITHINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 28 November 1990; FDA has authorised it.
Who is the marketing authorisation holder for EFLORNITHINE HYDROCHLORIDE in United States?
SANOFI AVENTIS US holds the US marketing authorisation.