🇺🇸 Relafen in United States

FDA authorised Relafen on 30 August 2019

Marketing authorisations

FDA — authorised 30 August 2019

  • Application: ANDA203166
  • Marketing authorisation holder: LGM PHARMA
  • Status: supplemented

FDA

  • Status: approved

Other Other approved in United States

Frequently asked questions

Is Relafen approved in United States?

Yes. FDA authorised it on 30 August 2019; FDA has authorised it.

Who is the marketing authorisation holder for Relafen in United States?

LGM PHARMA holds the US marketing authorisation.