FDA — authorised 14 January 1986
- Application: NDA018701
- Marketing authorisation holder: JANSSEN PHARMS
- Status: supplemented
🇺🇸 Haldol in United States
FDA authorised Haldol on 14 January 1986
Marketing authorisations
FDA — authorised 10 June 1986
- Application: ANDA070278
- Marketing authorisation holder: MYLAN
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 1986
- Application: ANDA071073
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 1986
- Application: ANDA071074
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 1986
- Application: ANDA071071
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 1986
- Application: ANDA071072
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 March 1987
- Application: ANDA070983
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 March 1987
- Application: ANDA070981
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 March 1987
- Application: ANDA070982
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 1987
- Application: ANDA071076
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 1987
- Application: ANDA071075
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 1987
- Application: ANDA071015
- Marketing authorisation holder: TEVA
- Local brand name: HALOPERIDOL
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 17 May 1988
- Application: ANDA070714
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 August 1991
- Application: ANDA072113
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 1993
- Application: ANDA072517
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 February 1993
- Application: ANDA072516
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 September 1993
- Application: ANDA073364
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: HALOPERIDOL
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 18 June 2001
- Application: ANDA075858
- Marketing authorisation holder: HIKMA
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 August 2001
- Application: ANDA076035
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 August 2004
- Application: ANDA076791
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 August 2004
- Application: ANDA076774
- Marketing authorisation holder: GLAND PHARMA LTD
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 August 2004
- Application: ANDA076828
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 September 2004
- Application: ANDA076464
- Marketing authorisation holder: FOSUN PHARMA
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 September 2009
- Application: ANDA078347
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 September 2011
- Application: ANDA200742
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 September 2017
- Application: ANDA204849
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 July 2019
- Application: ANDA210356
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 January 2020
- Application: ANDA211061
- Marketing authorisation holder: APPCO
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 July 2022
- Application: ANDA200854
- Marketing authorisation holder: ACTAVIS GROUP
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 November 2022
- Application: ANDA216004
- Marketing authorisation holder: MSN
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2024
- Application: ANDA218371
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: HALOPERIDOL
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 11 April 2024
- Application: ANDA216918
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2024
- Application: ANDA218789
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 December 2025
- Application: ANDA218162
- Marketing authorisation holder: CREEKWOOD PHARMS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
Creekwood Pharms received marketing authorisation from the FDA for Haldol (haloperidol) tablets on 18 December 2025. The approval was granted under the standard expedited pathway. Haldol is indicated for oral administration, but the specific indication is not specified in the available information.
FDA
- Application: ANDA070318
- Marketing authorisation holder: ALPHARMA
- Local brand name: HALOPERIDOL
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA
- Application: ANDA072727
- Marketing authorisation holder: LEDERLE
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072728
- Marketing authorisation holder: LEDERLE
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072121
- Marketing authorisation holder: ROYCE LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072729
- Marketing authorisation holder: LEDERLE
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071374
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071375
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072730
- Marketing authorisation holder: LEDERLE
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071376
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072731
- Marketing authorisation holder: LEDERLE
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072732
- Marketing authorisation holder: LEDERLE
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA017079
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: HALDOL SOLUTAB
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070710
- Marketing authorisation holder: MORTON GROVE
- Local brand name: HALOPERIDOL
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA
- Application: ANDA070713
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071328
- Marketing authorisation holder: PAR PHARM
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070723
- Marketing authorisation holder: SCS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070720
- Marketing authorisation holder: SCS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070721
- Marketing authorisation holder: SCS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070722
- Marketing authorisation holder: SCS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070724
- Marketing authorisation holder: SCS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070726
- Marketing authorisation holder: SCS
- Local brand name: HALOPERIDOL
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA
- Application: ANDA070725
- Marketing authorisation holder: SCS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071269
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071725
- Marketing authorisation holder: ROYCE LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071724
- Marketing authorisation holder: ROYCE LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071723
- Marketing authorisation holder: ROYCE LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071257
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071256
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071255
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA020074
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070744
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071082
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: HALOPERIDOL
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA072122
- Marketing authorisation holder: ROYCE LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- 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 Other approved in United States
Frequently asked questions
Is Haldol approved in United States?
Yes. FDA authorised it on 14 January 1986; FDA authorised it on 10 June 1986; FDA authorised it on 3 November 1986.
Who is the marketing authorisation holder for Haldol in United States?
JANSSEN PHARMS holds the US marketing authorisation.