FDA.reportPublic FDA data

Application 015923

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALDOLHALOPERIDOL LACTATEINJECTABLE;INJECTIONEQ 5MG BASE/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N015923-001HALDOLHALOPERIDOL LACTATEEQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N015923-001HALDOLEQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N015923-001HALDOLEQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N015923-001HALDOLEQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N015923-001HALDOLEQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N015923-001AP174a2ff9319b5…
2020-11-12 02:37 UTC2020-11N015923-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N015923-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N015923-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N015923-001AP1ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HALOPERIDOL LACTATEHALOPERIDOL LACTATEREMEDYREPACK INC.4289f7db-e25d-4578-8adf-f0222ae64aa62026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HALOPERIDOL LACTATE
HaloperidolHALOPERIDOL LACTATECardinal Health 107, LLCe2eed126-cb82-42b1-9b48-9cbeb6873b502026-06-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HALOPERIDOL LACTATE
HALOPERIDOL LACTATEHALOPERIDOL LACTATECardinal Health 107, LLC7d1a9689-23c8-44ef-a474-8c607e13d7942026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HALOPERIDOL LACTATE
HaloperidolHALOPERIDOL LACTATEREMEDYREPACK INC.e702b2f0-d464-41c3-977a-d37bb22c0ab02026-03-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HALOPERIDOL LACTATE
HaloperidolHALOPERIDOL LACTATEHikma Pharmaceuticals USA Inc.8397a841-f240-4767-9dcd-781e6d3f7c7f2024-12-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HALOPERIDOL LACTATE
HALOPERIDOL LACTATEHALOPERIDOL LACTATEMylan Institutional LLC909259a3-7627-4d1e-91d3-3363b34935992024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HALOPERIDOL LACTATE
HaloperidolHALOPERIDOL LACTATEHikma Pharmaceuticals USA Inc.ec7a3560-71c3-43f5-bc6c-d51eadfd2aa12022-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HALOPERIDOL LACTATE
HALOPERIDOLHALOPERIDOL LACTATEHF Acquisition Co LLC, DBA HealthFirstbeb6d1cf-98db-d0a5-e053-2995a90ace902021-03-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: HALOPERIDOL LACTATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10147-0911HaloperidolHaloperidolPatriot Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
10147-0911HaloperidolHaloperidolPatriot Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
10147-0911HaloperidolHaloperidolPatriot Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
10147-0911HaloperidolHaloperidolPatriot Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
50458-255HaldolHaloperidolJanssen Pharmaceuticals, Inc.NDACurrent
50458-255HaldolHaloperidolJanssen Pharmaceuticals, Inc.NDACurrent
50458-255HaldolHaloperidolJanssen Pharmaceuticals, Inc.NDACurrent
50458-255HaldolHaloperidolJanssen Pharmaceuticals, Inc.NDACurrent
50458-255HaldolHaloperidolJanssen Pharmaceuticals, Inc.NDACurrent
50458-255HaldolHaloperidolJanssen Pharmaceuticals, Inc.NDACurrent
64725-0911HaloperidolHaloperidolTYA PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65283SUPPL2020-11-19
65265SUPPL2020-11-18
65264SUPPL2020-11-18
57960SUPPL2019-03-12
57954SUPPL2019-03-12
50645SUPPL2017-12-08
50628SUPPL2017-12-07
47375SUPPL2017-03-02
47358SUPPL2017-02-27
10867SUPPL2016-05-20
409SUPPL2016-05-20
10866SUPPL2015-05-29
408SUPPL2015-05-28
12961SUPPL2013-05-07
10862SUPPL2011-08-16
403SUPPL2011-08-15
407SUPPL2011-03-07
10865SUPPL2011-03-04
406SUPPL2010-12-06
33135SUPPL2010-12-04
10864SUPPL2009-08-14
405SUPPL2009-08-04
10863SUPPL2008-08-29
12960SUPPL2008-08-19
33134SUPPL2008-06-05
404SUPPL2008-05-14
12959SUPPL2007-09-25
40701SUPPL2007-07-06
402SUPPL2007-05-09
10861SUPPL2007-05-07