FDA — authorised 5 December 1994
- Status: approved
🇺🇸 Luvox in United States
FDA authorised Luvox on 5 December 1994
Marketing authorisations
FDA — authorised 5 December 1994
- Application: NDA020243
- Marketing authorisation holder: SOLVAY
- Local brand name: LUVOX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 June 2007
- Application: ANDA075888
- Marketing authorisation holder: AIPING PHARM INC
- Indication: Labeling
- Status: approved
FDA — authorised 20 December 2007
- Application: NDA021519
- Marketing authorisation holder: ANI PHARMS
- Local brand name: LUVOX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 April 2008
- Application: NDA022235
- Marketing authorisation holder: JAZZ
- Local brand name: LUVOX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2013
- Application: ANDA091482
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Status: approved
FDA — authorised 18 August 2023
- Application: ANDA091476
- Marketing authorisation holder: PH HEALTH
- Indication: Labeling
- Status: approved
FDA — authorised 17 October 2024
- Application: ANDA219055
- Marketing authorisation holder: AJANTA PHARMA LTD
- Status: approved
Luvox 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 Luvox approved in United States?
Yes. FDA authorised it on 5 December 1994; FDA authorised it on 5 December 1994; FDA authorised it on 27 June 2007.
Who is the marketing authorisation holder for Luvox in United States?
Marketing authorisation holder not available in our data.