🇺🇸 Advil in United States

FDA authorised Advil on 20 April 1995

Marketing authorisations

FDA — authorised 20 April 1995

  • Application: NDA020402
  • Marketing authorisation holder: HALEON US HOLDINGS
  • Status: approved

FDA — authorised 30 May 2002

  • Application: NDA021374
  • Marketing authorisation holder: HALEON US HOLDINGS
  • Status: supplemented

FDA — authorised 21 December 2005

  • Application: NDA021394
  • Marketing authorisation holder: HALEON US HOLDINGS
  • Status: supplemented

FDA — authorised 21 December 2005

  • Application: NDA021393
  • Marketing authorisation holder: HALEON US HOLDINGS
  • Status: supplemented

FDA — authorised 24 March 2009

  • Application: ANDA078682
  • Marketing authorisation holder: BIONPHARMA
  • Status: supplemented

FDA

  • Status: approved

Other Other approved in United States

Frequently asked questions

Is Advil approved in United States?

Yes. FDA authorised it on 20 April 1995; FDA authorised it on 30 May 2002; FDA authorised it on 21 December 2005.

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

HALEON US HOLDINGS holds the US marketing authorisation.