🇺🇸 fexofenadine HCl in United States

FDA authorised fexofenadine HCl on 17 March 2010

Marketing authorisations

FDA — authorised 17 March 2010

  • Application: ANDA079043
  • Marketing authorisation holder: DR REDDYS LABS LTD
  • Status: supplemented

FDA — authorised 18 November 2014

  • Application: ANDA076667
  • Marketing authorisation holder: DR REDDYS
  • Status: approved

FDA — authorised 19 August 2016

  • Application: ANDA204097
  • Marketing authorisation holder: HETERO LABS LTD V
  • Status: approved

FDA — authorised 13 August 2018

  • Application: ANDA210137
  • Marketing authorisation holder: UNIQUE
  • Status: supplemented

FDA — authorised 18 October 2019

  • Application: ANDA211075
  • Marketing authorisation holder: GRANULES
  • Status: approved

Other Allergy/Immunology approved in United States

Frequently asked questions

Is fexofenadine HCl approved in United States?

Yes. FDA authorised it on 17 March 2010; FDA authorised it on 18 November 2014; FDA authorised it on 19 August 2016.

Who is the marketing authorisation holder for fexofenadine HCl in United States?

DR REDDYS LABS LTD holds the US marketing authorisation.