🇺🇸 Flavor in United States

FDA authorised Flavor on 15 March 1999

Marketing authorisations

FDA — authorised 15 March 1999

  • Application: ANDA074507
  • Marketing authorisation holder: P AND L
  • Status: supplemented

FDA — authorised 29 December 2008

  • Application: ANDA078697
  • Marketing authorisation holder: P AND L
  • Status: supplemented

FDA — authorised 29 December 2008

  • Application: ANDA078699
  • Marketing authorisation holder: P AND L
  • Status: supplemented

FDA — authorised 13 April 2015

  • Application: ANDA204559
  • Marketing authorisation holder: STRIDES PHARMA
  • Status: approved

FDA — authorised 21 December 2018

  • Application: ANDA204558
  • Marketing authorisation holder: STRIDES PHARMA
  • Status: supplemented

FDA

  • Status: approved

Other Other approved in United States

Frequently asked questions

Is Flavor approved in United States?

Yes. FDA authorised it on 15 March 1999; FDA authorised it on 29 December 2008; FDA authorised it on 29 December 2008.

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

P AND L holds the US marketing authorisation.