FDA — authorised 29 December 1987
- Application: NDA018936
- Marketing authorisation holder: ELI LILLY AND CO
- Local brand name: PROZAC
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 SSRI in United States
FDA authorised SSRI on 29 December 1987
Marketing authorisations
FDA — authorised 29 August 2002
- Application: NDA021440
- Marketing authorisation holder: FOREST LABS
- Local brand name: LEXAPRO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 2002
- Application: NDA021365
- Marketing authorisation holder: ABBVIE
- Local brand name: LEXAPRO
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Status: approved
SSRI 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 SSRI approved in United States?
Yes. FDA authorised it on 29 December 1987; FDA authorised it on 29 August 2002; FDA authorised it on 27 November 2002.
Who is the marketing authorisation holder for SSRI in United States?
ELI LILLY AND CO holds the US marketing authorisation.