FDA — authorised 9 July 1993
- Marketing authorisation holder: ROXANE
- Status: approved
🇺🇸 Orlaam in United States
FDA authorised Orlaam on 9 July 1993
Marketing authorisations
FDA — authorised 9 July 1993
- Application: NDA020315
- Marketing authorisation holder: ROXANE
- Local brand name: ORLAAM
- Indication: CONCENTRATE — ORAL
- Status: approved
Orlaam in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Orlaam approved in United States?
Yes. FDA authorised it on 9 July 1993; FDA authorised it on 9 July 1993.
Who is the marketing authorisation holder for Orlaam in United States?
ROXANE holds the US marketing authorisation.