Haloperidol Lactate

Sold as Haldol. Every FDA application for this active ingredient: 2 branded and 33 generic.

As of Nov 14, 2026, FDA lists 35 applications for Haloperidol Lactate (sold as Haldol), first approved Apr 12, 1967, with 0 new uses approved and 0 published complete response letters.

First approved: Apr 12, 1967
Applications: 35
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.5M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Haloperidol Lactate	Part D	$1.5M	-8%	36,697
Haldol	Part B	$0K	-14%	125

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

HALOPERIDOL 0.5 MG TABLET: $0.091 per unitGeneric · -6% in a year
HALOPERIDOL 1 MG TABLET: $0.135 per unitGeneric · -11% in a year
HALOPERIDOL 10 MG TABLET: $0.147 per unitGeneric · -42% in a year
HALOPERIDOL 2 MG TABLET: $0.178 per unitGeneric · +11% in a year
HALOPERIDOL 20 MG TABLET: $0.359 per unitGeneric · +4% in a year
HALOPERIDOL 5 MG TABLET: $0.171 per unitGeneric · -10% in a year

Clinical Trials

12 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Quality of Life, Safety and Compliance of Patients Using Monotherapy or Combinatorial Therapy With Quetiapine for Treatment of Schizophrenia or Bipolar Affective DisorderSchizophrenia, Bipolar Affective Disorder · Bosnalijek D.D	—	Recruiting	Oct 5, 2026
Haloperidol For Outpatient Symptom Management in Patients Diagnosed With Cannabinoid Hyperemesis Syndrome in the Emergrency DepartmentCannabinoid Hyperemesis Syndrome · University of Illinois Chicago	Early phase 1	Not yet recruiting	Jul 24, 2026
Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect?Brain Insulin Sensitivity, Healthy Controls · Centre for Addiction and Mental Health	Phase 4	Recruiting	Aug 7, 2025
Comparison of Haloperidol and Dexmedetomidine for Delirium and Agitation in ICU Patients With Traumatic Brain InjuryTraumatic Brain Injury, Delirium · Benha University	Not applicable	Not yet recruiting	May 28, 2025
Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency DepartmentBack Pain, Chronic Pain · Western Michigan University School of Medicine	Phase 4	Recruiting	May 2, 2024
The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBMGlioblastoma Multiforme · Southern Medical University, China	Phase 2	Not yet recruiting	Jan 23, 2024
Maternal And Infant Antipsychotic StudyAntipsychotics, Pregnancy · Icahn School of Medicine at Mount Sinai	—	Recruiting	Sep 22, 2023
The Danish Out-of-Hospital Cardiac Arrest StudyOut-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome · Christian Hassager	Phase 3	Active, not recruiting	Jun 9, 2023

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 12, 1967	HaldolNDA 15922 · New dosage form	Ortho Mcneil	32	Discontinued
May 18, 1971	HaldolNDA 15923 · New dosage form	Janssen Pharms	56	Discontinued
Jan 20, 1987	HaloperidolANDA 71187	Abraxis Pharm	2	Discontinued
Aug 25, 1987	HaloperidolANDA 71015	Teva	17	Discontinued
Apr 12, 1988	Haloperidol IntensolANDA 72045	Hikma	2	Discontinued
May 17, 1988	HaloperidolANDA 70714	Watson Labs	4	Discontinued
Dec 1, 1988	HaloperidolANDA 71617	Teva Pharms	24	Discontinued
Feb 25, 1993	HaloperidolANDA 72516	Marsam Pharms LLC	0	Discontinued
Feb 25, 1993	HaloperidolANDA 72517	Marsam Pharms LLC	0	Discontinued
Feb 26, 1993	HaloperidolANDA 73037	Pharm Assoc	10	Marketed
Sep 28, 1993	HaloperidolANDA 73364	Lannett Co Inc	8	Marketed
Nov 2, 1995	Haloperidol LactateANDA 74536	Actavis Mid Atlantic	2	Discontinued
Mar 9, 2001	HaloperidolANDA 75689	Fresenius Kabi USA	13	Marketed
Jun 18, 2001	HaloperidolANDA 75858	Hikma	14	Marketed
Aug 29, 2001	HaloperidolANDA 76035	Teva Pharms USA	9	Discontinued
Aug 25, 2004	HaloperidolANDA 76791	Baxter Hlthcare Corp	5	Discontinued
Aug 25, 2004	HaloperidolANDA 76828	Baxter Hlthcare Corp	4	Discontinued
Aug 25, 2004	HaloperidolANDA 76774	Gland Pharma Ltd	4	Discontinued
Sep 29, 2004	HaloperidolANDA 76464	Fosun Pharma	2	Discontinued
Sep 14, 2009	HaloperidolANDA 78347	Mylan Labs Ltd	7	Marketed
Sep 2, 2011	HaloperidolANDA 91637	Sagent Pharms	7	Marketed
Sep 2, 2011	HaloperidolANDA 200742	Sagent Pharms	6	Marketed
Sep 6, 2017	HaloperidolANDA 204849	Epic Pharma LLC	3	Discontinued
Jul 1, 2019	HaloperidolANDA 210356	Fresenius Kabi USA	2	Discontinued
Jan 31, 2024	HaloperidolANDA 218371	Rubicon Research	1	Marketed
—	HaloperidolANDA 70710	Morton Grove	0	Discontinued
—	HaloperidolANDA 70713	Watson Labs	0	Discontinued
—	HaloperidolANDA 70318	Alpharma	0	Discontinued
—	HaloperidolANDA 70726	Scs	0	Discontinued
—	HaloperidolANDA 70744	Watson Labs	0	Discontinued
—	HaloperidolANDA 70800	Solopak	0	Discontinued
—	HaloperidolANDA 70801	Solopak	0	Discontinued
—	HaloperidolANDA 70802	Smith And Nephew	0	Discontinued
—	HaloperidolANDA 70864	Solopak	0	Discontinued
—	HaloperidolANDA 71082	Quad Pharms	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA