🇺🇸 Sertraline HCl in United States

FDA authorised Sertraline HCl on 4 October 2021

Marketing authorisations

FDA — authorised 4 October 2021

  • Application: NDA215133
  • Marketing authorisation holder: ALMATICA
  • Status: approved

FDA — authorised 20 January 2026

  • Application: ANDA218342
  • Marketing authorisation holder: UMEDICA
  • Status: approved

FDA — authorised 28 January 2026

  • Application: ANDA219655
  • Marketing authorisation holder: AMNEAL
  • Status: approved

Other Psychiatry / Neurology approved in United States

Frequently asked questions

Is Sertraline HCl approved in United States?

Yes. FDA authorised it on 4 October 2021; FDA authorised it on 20 January 2026; FDA authorised it on 28 January 2026.

Who is the marketing authorisation holder for Sertraline HCl in United States?

ALMATICA holds the US marketing authorisation.