FDA — authorised 12 April 1967
- Application: NDA015922
- Marketing authorisation holder: ORTHO MCNEIL
- Local brand name: HALDOL
- Indication: CONCENTRATE — ORAL
- Status: approved
🇺🇸 Haldol in United States
FDA authorised Haldol on 12 April 1967
Marketing authorisations
FDA — authorised 12 April 1967
- Application: NDA015921
- Marketing authorisation holder: ORTHO MCNEIL
- Local brand name: HALDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 May 1971
- Application: NDA015923
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: HALDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 January 1986
- Marketing authorisation holder: JANSSEN PHARMS
- Status: approved
FDA — authorised 14 January 1986
- Application: NDA018701
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: HALDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 December 1997
- Application: ANDA074893
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: HALOPERIDOL DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 September 1998
- Application: ANDA075305
- Marketing authorisation holder: HIKMA
- Local brand name: HALOPERIDOL DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 May 1999
- Application: ANDA075393
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: HALOPERIDOL DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 February 2000
- Application: ANDA075176
- Marketing authorisation holder: HOSPIRA
- Local brand name: HALOPERIDOL DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 February 2000
- Application: ANDA075440
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: HALOPERIDOL DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 June 2005
- Application: ANDA076463
- Marketing authorisation holder: SANDOZ
- Local brand name: HALOPERIDOL DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 May 2017
- Application: ANDA205241
- Marketing authorisation holder: GLAND
- Local brand name: HALOPERIDOL DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 July 2018
- Application: ANDA209101
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: HALOPERIDOL DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 October 2019
- Application: ANDA211180
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: HALOPERIDOL DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 July 2021
- Application: ANDA214507
- Marketing authorisation holder: MEITHEAL
- Local brand name: HALOPERIDOL DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 May 2023
- Application: ANDA216730
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: HALOPERIDOL DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 May 2025
- Application: ANDA219168
- Marketing authorisation holder: CAPLIN
- Local brand name: HALOPERIDOL DECANOATE
- Indication: INJECTABLE — INJECTION
- Status: approved
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 12 April 1967; FDA authorised it on 12 April 1967; FDA authorised it on 18 May 1971.
Who is the marketing authorisation holder for Haldol in United States?
ORTHO MCNEIL holds the US marketing authorisation.