🇺🇸 Singulair in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Singulair (montelukast) regulatory status in United States.

Marketing authorisation

FDA

Status: approved

Other Neuroscience approved in United States

Frequently asked questions

Is Singulair approved in United States?

Yes. FDA has authorised it.

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

Merck & Co. is the originator. The local marketing authorisation holder may differ — check the official source linked above.