🇺🇸 phenylacetate in United States

FDA authorised phenylacetate on 24 February 2016

Marketing authorisations

FDA — authorised 24 February 2016

  • Application: ANDA207096
  • Marketing authorisation holder: AILEX PHARMS LLC
  • Status: approved

FDA — authorised 4 August 2016

  • Application: ANDA205880
  • Marketing authorisation holder: NAVINTA LLC
  • Status: approved

FDA — authorised 8 May 2017

  • Application: ANDA208521
  • Marketing authorisation holder: MAIA PHARMS INC
  • Status: approved

FDA — authorised 10 June 2021

  • Application: NDA215025
  • Marketing authorisation holder: MAIA PHARMS INC
  • Status: approved

FDA — authorised 14 July 2023

  • Application: ANDA217526
  • Marketing authorisation holder: NAVINTA LLC
  • Status: approved

FDA

  • Status: approved

Other Other approved in United States

Frequently asked questions

Is phenylacetate approved in United States?

Yes. FDA authorised it on 24 February 2016; FDA authorised it on 4 August 2016; FDA authorised it on 8 May 2017.

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

AILEX PHARMS LLC holds the US marketing authorisation.