FDA — authorised 3 April 1992
- Application: ANDA071173
- Marketing authorisation holder: INNOGENIX
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Haldol in United States
FDA authorised Haldol on 3 April 1992
Marketing authorisations
FDA — authorised 26 February 2010
- Application: ANDA073037
- Marketing authorisation holder: PHARM ASSOC
- Indication: Labeling
- Status: approved
FDA — authorised 22 October 2019
- Application: ANDA211180
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
FDA — authorised 12 November 2021
- Application: ANDA209101
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Indication: Labeling
- Status: approved
FDA — authorised 12 September 2025
- Application: ANDA214507
- Marketing authorisation holder: MEITHEAL
- Indication: Labeling
- Status: approved
The FDA approved MEITHEAL's Haldol on 12 September 2025, under standard expedited pathway (application number: ANDA214507). Haldol is indicated for use in the labelling. This approval allows MEITHEAL to market Haldol in the United States.
Haldol 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 Haldol approved in United States?
Yes. FDA authorised it on 3 April 1992; FDA authorised it on 26 February 2010; FDA authorised it on 22 October 2019.
Who is the marketing authorisation holder for Haldol in United States?
INNOGENIX holds the US marketing authorisation.