FDA — authorised 13 August 2010
- Application: NDA022474
- Marketing authorisation holder: LAB HRA PHARMA
- Local brand name: ELLA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 UPA-EC in United States
FDA authorised UPA-EC on 13 August 2010
Marketing authorisations
FDA
- Status: approved
UPA-EC 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 UPA-EC approved in United States?
Yes. FDA authorised it on 13 August 2010; FDA has authorised it.
Who is the marketing authorisation holder for UPA-EC in United States?
LAB HRA PHARMA holds the US marketing authorisation.