FDA — authorised 10 June 1986
- Application: ANDA070278
- Marketing authorisation holder: MYLAN
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Haloperidol Injection in United States
FDA authorised Haloperidol Injection on 10 June 1986 · 79 US adverse-event reports
Marketing authorisations
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: 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: ANDA071072
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 November 1986
- Application: ANDA071207
- Marketing authorisation holder: SANDOZ
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 November 1986
- Application: ANDA071206
- Marketing authorisation holder: SANDOZ
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 November 1986
- Application: ANDA071208
- Marketing authorisation holder: SANDOZ
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 January 1987
- Application: ANDA071187
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 February 1987
- Application: ANDA071128
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 February 1987
- Application: ANDA071130
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 February 1987
- Application: ANDA071129
- Marketing authorisation holder: AIPING PHARM INC
- 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: ANDA070984
- 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 12 May 1987
- Application: ANDA071133
- Marketing authorisation holder: AIPING PHARM INC
- 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 4 August 1987
- Application: ANDA071076
- 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 7 January 1988
- Application: ANDA071173
- Marketing authorisation holder: INNOGENIX
- Local brand name: HALOPERIDOL
- Indication: TABLET — 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: ANDA072353
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- 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: ANDA072516
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- 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 26 February 1993
- Application: ANDA073037
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: HALOPERIDOL
- Indication: CONCENTRATE — ORAL
- 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: ANDA076828
- 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 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: ANDA091637
- Marketing authorisation holder: SAGENT PHARMS
- 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
FDA
- Application: ANDA072730
- Marketing authorisation holder: LEDERLE
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072727
- 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: ANDA070710
- Marketing authorisation holder: MORTON GROVE
- Local brand name: HALOPERIDOL
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA
- Application: NDA017079
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: HALDOL SOLUTAB
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070713
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- 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: ANDA070723
- 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: ANDA070725
- 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: ANDA071571
- Marketing authorisation holder: WATSON LABS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072122
- Marketing authorisation holder: ROYCE LABS
- 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: ANDA071328
- Marketing authorisation holder: PAR PHARM
- 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: 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: ANDA070318
- Marketing authorisation holder: ALPHARMA
- Local brand name: HALOPERIDOL
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA
- Application: ANDA071269
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071722
- 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: ANDA070800
- Marketing authorisation holder: SOLOPAK
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070801
- Marketing authorisation holder: SOLOPAK
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070802
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA020074
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072728
- Marketing authorisation holder: LEDERLE
- Local brand name: HALOPERIDOL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070864
- Marketing authorisation holder: SOLOPAK
- Local brand name: HALOPERIDOL
- Indication: INJECTABLE — INJECTION
- 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
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 79
Most-reported reactions
- Neuroleptic Malignant Syndrome — 19 reports (24.05%)
- Product Use In Unapproved Indication — 9 reports (11.39%)
- Pulmonary Embolism — 9 reports (11.39%)
- Product Use Issue — 8 reports (10.13%)
- Cardiac Arrest — 7 reports (8.86%)
- Catatonia — 6 reports (7.59%)
- Torsade De Pointes — 6 reports (7.59%)
- Condition Aggravated — 5 reports (6.33%)
- Drug Interaction — 5 reports (6.33%)
- Seizure — 5 reports (6.33%)
Other Psychiatry approved in United States
Frequently asked questions
Is Haloperidol Injection approved in United States?
Yes. FDA authorised it on 10 June 1986; FDA authorised it on 3 November 1986; FDA authorised it on 3 November 1986.
Who is the marketing authorisation holder for Haloperidol Injection in United States?
MYLAN holds the US marketing authorisation.