FDA — authorised 18 September 1957
- Application: NDA011120
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: THORAZINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Thorazine in United States
FDA authorised Thorazine on 18 September 1957
Marketing authorisations
FDA — authorised 20 November 1957
- Application: NDA009149
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: THORAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 2021
- Application: ANDA212996
- Marketing authorisation holder: LANNETT CO INC
- Status: approved
FDA — authorised 2 June 2021
- Application: ANDA214542
- Marketing authorisation holder: GENUS
- Status: approved
FDA — authorised 29 November 2021
- Application: ANDA212630
- Marketing authorisation holder: ZAMEER PHARMS
- Status: approved
FDA — authorised 15 March 2024
- Application: ANDA213368
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Indication: Labeling
- Status: approved
The FDA approved Thorazine, a medication, for marketing in the United States on 15 March 2024. The approval was granted to ZYDUS LIFESCIENCES, the marketing authorisation holder. The application number for this approval is ANDA213368.
FDA — authorised 10 October 2025
- Application: ANDA216678
- Marketing authorisation holder: RUBICON
- Status: approved
Thorazine 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 Thorazine approved in United States?
Yes. FDA authorised it on 18 September 1957; FDA authorised it on 20 November 1957; FDA authorised it on 22 January 2021.
Who is the marketing authorisation holder for Thorazine in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.