FDA — authorised 22 December 1994
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Status: approved
🇺🇸 Serzone in United States
FDA authorised Serzone on 22 December 1994
Marketing authorisations
FDA — authorised 17 July 2014
- Application: ANDA076037
- Marketing authorisation holder: TEVA
- Indication: Labeling
- Status: approved
Serzone 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 Serzone approved in United States?
Yes. FDA authorised it on 22 December 1994; FDA authorised it on 17 July 2014.
Who is the marketing authorisation holder for Serzone in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.