FDA Orange Book · active-ingredient family
Haloperidol
Haloperidol: 2 brands, 65 generics; first approved Feb 02, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 65 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
65
Listed patents
0
Presentations
133
Brand (NDA) products
Originator applications
- HALDOLRLDORTHO MCNEILNDA 015921-6 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued - 1MG TABLET ORAL Discontinued - 2MG TABLET ORAL Discontinued - 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - 20MG TABLET ORAL Discontinued - - ORTHO MCNEIL PHARMNDA 017079-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued -
Generic (ANDA) products (65)
Abbreviated applications
- HALOPERIDOLALEMBICANDA 21447020265 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - HALOPERIDOLAIPING PHARM INCANDA 07113020266 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - HALOPERIDOLCREEKWOOD PHARMSANDA 21816220256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - HALOPERIDOLAUROBINDO PHARMA LTDANDA 21878920246 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - HALOPERIDOLMANKIND PHARMAANDA 21691820246 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - HALOPERIDOLZYDUS PHARMS USAANDA 07758020236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB - HALOPERIDOLMSNANDA 21600420226 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - HALOPERIDOLACTAVIS GROUPANDA 20085420226 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued - 1MG TABLET ORAL Discontinued - 2MG TABLET ORAL Discontinued - 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - 20MG TABLET ORAL Discontinued - - HALOPERIDOLAPPCOANDA 21106120206 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - HALOPERIDOLWATSON LABSANDA 0721131991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HALOPERIDOLWATSON LABSANDA 0723531991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - HALOPERIDOLLEDERLEANDA 0727271989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued - - HALOPERIDOLLEDERLEANDA 0727281989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - - HALOPERIDOLLEDERLEANDA 0727291989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued - - HALOPERIDOLLEDERLEANDA 0727301989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - HALOPERIDOLLEDERLEANDA 0727311989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HALOPERIDOLLEDERLEANDA 0727321989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - HALOPERIDOLWATSON LABSANDA 0715711988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued - - HALOPERIDOLWATSON LABSANDA 0715721988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - - HALOPERIDOLWATSON LABSANDA 0715731988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued - - HALOPERIDOLWATSON LABSANDA 0713741988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - HALOPERIDOLWATSON LABSANDA 0713751988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HALOPERIDOLWATSON LABSANDA 0713761988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - HALOPERIDOLCHARTWELL RXANDA 0712101988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB - HALOPERIDOLCHARTWELL RXANDA 0712111988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB - HALOPERIDOLROYCE LABSANDA 0717221987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued - - HALOPERIDOLROYCE LABSANDA 0717231987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - - HALOPERIDOLROYCE LABSANDA 0717241987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued - - HALOPERIDOLROYCE LABSANDA 0717251987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - HALOPERIDOLROYCE LABSANDA 0721211987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HALOPERIDOLROYCE LABSANDA 0721221987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - HALOPERIDOLPUREPAC PHARMANDA 0710751987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HALOPERIDOLPUREPAC PHARMANDA 0710761987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - HALOPERIDOLPAR PHARMANDA 0713281987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - HALOPERIDOLDURAMED PHARMS BARRANDA 0712201987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued - - HALOPERIDOLDURAMED PHARMS BARRANDA 0712211987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - HALOPERIDOLAIPING PHARM INCANDA 0711331987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - HALOPERIDOLWATSON LABSANDA 0709811987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued - - HALOPERIDOLWATSON LABSANDA 0709821987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - - HALOPERIDOLWATSON LABSANDA 0709831987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued - - HALOPERIDOLWATSON LABSANDA 0709841987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - HALOPERIDOLAIPING PHARM INCANDA 0711281987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued - - HALOPERIDOLAIPING PHARM INCANDA 0711291987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - - HALOPERIDOLQUANTUM PHARMICSANDA 0712551987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued - - HALOPERIDOLQUANTUM PHARMICSANDA 0712691987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - - HALOPERIDOLQUANTUM PHARMICSANDA 0712561987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued - - HALOPERIDOLQUANTUM PHARMICSANDA 0712571987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - HALOPERIDOLINNOGENIXANDA 07117319876 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - HALOPERIDOLDURAMED PHARMS BARRANDA 0712161986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued - - HALOPERIDOLDURAMED PHARMS BARRANDA 0712171986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - - HALOPERIDOLDURAMED PHARMS BARRANDA 0712181986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued - - HALOPERIDOLDURAMED PHARMS BARRANDA 0712191986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - HALOPERIDOLCHARTWELL RXANDA 07120919864 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 0.5MG TABLET ORAL Rx AB 1MG TABLET ORAL Rx AB 2MG TABLET ORAL Discontinued - - HALOPERIDOLPUREPAC PHARMANDA 0710711986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued - - HALOPERIDOLPUREPAC PHARMANDA 0710721986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - - HALOPERIDOLPUREPAC PHARMANDA 0710731986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued - - HALOPERIDOLPUREPAC PHARMANDA 0710741986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - HALOPERIDOLSTRIDES PHARMA INTLANDA 07123519865 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued - 0.5MG TABLET ORAL Discontinued - 1MG TABLET ORAL Discontinued - 5MG TABLET ORAL Discontinued - 10MG TABLET ORAL Discontinued - - HALOPERIDOLSCSANDA 0707251986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued - - HALOPERIDOLMYLANANDA 07027819866 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AB 10MG TABLET ORAL Discontinued - 20MG TABLET ORAL Discontinued - 1MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB 0.5MG TABLET ORAL Rx AB - HALOPERIDOLSCSANDA 0707201986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued - - HALOPERIDOLSCSANDA 0707211986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued - - HALOPERIDOLSCSANDA 0707221986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued - - HALOPERIDOLSCSANDA 0707231986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued - - HALOPERIDOLSCSANDA 0707241986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued -
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
45 yr 4 mo ago
Most recent approval
5 mo ago
Approvals span 1982–2026 across 67 FDA applications.
Brand (NDA) 23%
Generic (ANDA) 6597%
Haloperidol: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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