🇺🇸 fluticasone propionate and salmeterol in United States

FDA authorised fluticasone propionate and salmeterol on 24 August 2000

Marketing authorisations

FDA — authorised 24 August 2000

  • Application: NDA021077
  • Marketing authorisation holder: GLAXO GRP LTD
  • Status: supplemented

FDA — authorised 8 June 2006

  • Application: NDA021254
  • Marketing authorisation holder: GLAXO GRP LTD
  • Status: supplemented

FDA — authorised 27 January 2017

  • Application: NDA208799
  • Marketing authorisation holder: TEVA PHARM
  • Status: approved

FDA — authorised 17 December 2020

  • Application: ANDA203433
  • Marketing authorisation holder: HIKMA
  • Status: supplemented

FDA — authorised 13 December 2021

  • Application: ANDA213948
  • Marketing authorisation holder: TEVA PHARMS USA
  • Status: approved

Other Respiratory/Pulmonology approved in United States

Frequently asked questions

Is fluticasone propionate and salmeterol approved in United States?

Yes. FDA authorised it on 24 August 2000; FDA authorised it on 8 June 2006; FDA authorised it on 27 January 2017.

Who is the marketing authorisation holder for fluticasone propionate and salmeterol in United States?

GLAXO GRP LTD holds the US marketing authorisation.