🇺🇸 escitalopram and eszopiclone in United States

FDA authorised escitalopram and eszopiclone on 15 December 2004

Marketing authorisations

FDA — authorised 15 December 2004

  • Application: NDA021476
  • Marketing authorisation holder: WAYLIS THERAP
  • Local brand name: LUNESTA
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

FDA

  • Status: approved

escitalopram and eszopiclone in other countries

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

Frequently asked questions

Is escitalopram and eszopiclone approved in United States?

Yes. FDA authorised it on 15 December 2004; FDA has authorised it.

Who is the marketing authorisation holder for escitalopram and eszopiclone in United States?

WAYLIS THERAP holds the US marketing authorisation.