FDA — authorised 16 April 1959
- Application: NDA011552
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: STELAZINE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Stelazine in United States
FDA authorised Stelazine on 16 April 1959
Marketing authorisations
FDA — authorised 16 April 1959
- Status: approved
FDA — authorised 5 May 1999
- Application: ANDA085789
- Marketing authorisation holder: SANDOZ
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 15 June 1999
- Application: ANDA085788
- Marketing authorisation holder: SANDOZ
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 15 June 1999
- Application: ANDA085786
- Marketing authorisation holder: SANDOZ
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 9 May 2001
- Application: ANDA085785
- Marketing authorisation holder: SANDOZ
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 8 September 2008
- Application: ANDA040209
- Marketing authorisation holder: MYLAN
- Indication: Labeling
- Status: approved
Stelazine 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 Stelazine approved in United States?
Yes. FDA authorised it on 16 April 1959; FDA authorised it on 16 April 1959; FDA authorised it on 5 May 1999.
Who is the marketing authorisation holder for Stelazine in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.