FDA — authorised 29 December 1987
- Application: NDA018936
- Marketing authorisation holder: ELI LILLY AND CO
- Local brand name: SARAFEM
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Prozac in United States
FDA authorised Prozac on 29 December 1987
Marketing authorisations
FDA — authorised 19 May 2006
- Application: NDA021860
- Marketing authorisation holder: APIL
- Local brand name: SARAFEM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 August 2009
- Application: ANDA076006
- Marketing authorisation holder: DR REDDYS
- Indication: Labeling
- Status: approved
FDA — authorised 19 August 2014
- Application: ANDA076001
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 2 September 2021
- Application: ANDA206937
- Marketing authorisation holder: TORRENT
- Indication: Labeling
- Status: approved
FDA — authorised 29 March 2022
- Application: ANDA216232
- Marketing authorisation holder: MICRO LABS
- Status: approved
FDA — authorised 14 January 2026
- Application: ANDA077528
- Marketing authorisation holder: TEVA PHARMS
- Indication: Labeling
- Status: approved
Teva Pharms was granted marketing authorisation for Prozac by the FDA on 14 January 2026. The approval was based on a standard application pathway. Prozac is indicated for use in accordance with its approved labeling.
Prozac 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 Prozac approved in United States?
Yes. FDA authorised it on 29 December 1987; FDA authorised it on 19 May 2006; FDA authorised it on 21 August 2009.
Who is the marketing authorisation holder for Prozac in United States?
ELI LILLY AND CO holds the US marketing authorisation.