🇺🇸 Singulair in United States

FDA authorised Singulair on 20 February 1998

Marketing authorisations

FDA — authorised 20 February 1998

  • Application: NDA020829
  • Marketing authorisation holder: ORGANON
  • Status: supplemented

FDA — authorised 20 February 1998

  • Application: NDA020830
  • Marketing authorisation holder: ORGANON
  • Status: supplemented

FDA — authorised 26 July 2002

  • Application: NDA021409
  • Marketing authorisation holder: ORGANON
  • Status: supplemented

FDA

  • Status: approved

Singulair in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Respiratory approved in United States

Frequently asked questions

Is Singulair approved in United States?

Yes. FDA authorised it on 20 February 1998; FDA authorised it on 20 February 1998; FDA authorised it on 26 July 2002.

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

ORGANON holds the US marketing authorisation.