FDA — authorised 21 May 2012
- Application: ANDA077206
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
🇺🇸 Zoloft in United States
FDA authorised Zoloft on 21 May 2012
Marketing authorisations
FDA — authorised 23 December 2016
- Application: NDA020990
- Marketing authorisation holder: VIATRIS
- Indication: Labeling
- Status: approved
FDA — authorised 8 December 2017
- Application: NDA019839
- Marketing authorisation holder: VIATRIS
- Indication: Labeling
- Status: approved
FDA — authorised 31 March 2023
- Application: ANDA078403
- Marketing authorisation holder: GRANULES
- Indication: Labeling
- Status: approved
FDA — authorised 28 January 2026
- Application: ANDA219655
- Marketing authorisation holder: AMNEAL
- Status: approved
Zoloft in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Zoloft approved in United States?
Yes. FDA authorised it on 21 May 2012; FDA authorised it on 23 December 2016; FDA authorised it on 8 December 2017.
Who is the marketing authorisation holder for Zoloft in United States?
AUROBINDO PHARMA holds the US marketing authorisation.