FDA — authorised 26 May 2006
- Application: NDA050805
- Marketing authorisation holder: GALDERMA LABS LP
- Status: supplemented
🇺🇸 Oracea in United States
FDA authorised Oracea on 26 May 2006
Marketing authorisations
FDA
- Status: approved
Oracea in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Oracea approved in United States?
Yes. FDA authorised it on 26 May 2006; FDA has authorised it.
Who is the marketing authorisation holder for Oracea in United States?
GALDERMA LABS LP holds the US marketing authorisation.