FDA Orange Book · active-ingredient family
Haloperidol lactate
Haloperidol lactate: 2 brands, 32 generics; first approved Mar 07, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 32 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
32
Listed patents
0
Presentations
34
Brand (NDA) products
Originator applications
- HALDOLRLDORTHO MCNEILNDA 015922—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML CONCENTRATE ORAL Discontinued — - HALDOLRLDJANSSEN PHARMSNDA 015923—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (32)
Abbreviated applications
- RUBICON RESEARCHANDA 2183712024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML CONCENTRATE ORAL Rx AA - FRESENIUS KABI USAANDA 2103562019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - EPIC PHARMA LLCANDA 2048492017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - SAGENT PHARMSANDA 0916372011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - SAGENT PHARMSANDA 2007422011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - MYLAN LABS LTDANDA 0783472009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - FOSUN PHARMAANDA 0764642004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - BAXTER HLTHCARE CORPANDA 0767912004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - BAXTER HLTHCARE CORPANDA 0768282004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - GLAND PHARMA LTDANDA 0767742004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - TEVA PHARMS USAANDA 0760352001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - HIKMAANDA 0758582001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - FRESENIUS KABI USAANDA 0756892001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - HALOPERIDOL LACTATEACTAVIS MID ATLANTICANDA 0745361995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML SOLUTION ORAL Discontinued — - LANNETT CO INCANDA 0733641993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML CONCENTRATE ORAL Rx AA - PHARM ASSOCANDA 0730371993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML CONCENTRATE ORAL Rx AA - MARSAM PHARMS LLCANDA 0725161993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - MARSAM PHARMS LLCANDA 0725171993
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - TEVA PHARMSANDA 0716171988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML CONCENTRATE ORAL Discontinued — - WATSON LABSANDA 0707131988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - WATSON LABSANDA 0707141988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - WATSON LABSANDA 0707441988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - HIKMAANDA 0720451988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML CONCENTRATE ORAL Discontinued — - SMITH AND NEPHEWANDA 0708021987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - SOLOPAKANDA 0708001987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - SOLOPAKANDA 0708011987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - SOLOPAKANDA 0708641987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - TEVAANDA 0710151987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML CONCENTRATE ORAL Discontinued — - ABRAXIS PHARMANDA 0711871987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Discontinued — - SCSANDA 0707261986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML CONCENTRATE ORAL Discontinued — - ALPHARMAANDA 0703181986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML CONCENTRATE ORAL Discontinued — - MORTON GROVEANDA 0707101986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2MG BASE/ML CONCENTRATE 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
41 yr 2 mo ago
Most recent approval
2 yr 9 mo ago
Approvals span 1986–2024 across 34 FDA applications.
Brand (NDA) 26%
Generic (ANDA) 3294%
Haloperidol lactate: 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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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