FDA.reportPublic FDA data

Application 018701

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALDOLHALOPERIDOL DECANOATEINJECTABLE;INJECTIONEQ 50MG BASE/MLYesYes
002HALDOLHALOPERIDOL DECANOATEINJECTABLE;INJECTIONEQ 100MG BASE/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10147-0921Haloperidol DecanoateHaloperidol DecanoatePatriot Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
10147-0921Haloperidol DecanoateHaloperidol DecanoatePatriot Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
10147-0921Haloperidol DecanoateHaloperidol DecanoatePatriot Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
10147-0921Haloperidol DecanoateHaloperidol DecanoatePatriot Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
10147-0922Haloperidol DecanoateHaloperidol DecanoatePatriot Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
10147-0922Haloperidol DecanoateHaloperidol DecanoatePatriot Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
10147-0922Haloperidol DecanoateHaloperidol DecanoatePatriot Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
10147-0922Haloperidol DecanoateHaloperidol DecanoatePatriot Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
50458-253Haldol DecanoateHaloperidol DecanoateJanssen Pharmaceuticals, Inc.NDACurrent
50458-253Haldol DecanoateHaloperidol DecanoateJanssen Pharmaceuticals, Inc.NDACurrent
50458-253Haldol DecanoateHaloperidol DecanoateJanssen Pharmaceuticals, Inc.NDACurrent
50458-253Haldol DecanoateHaloperidol DecanoateJanssen Pharmaceuticals, Inc.NDACurrent
50458-254Haldol DecanoateHaloperidol DecanoateJanssen Pharmaceuticals, Inc.NDACurrent
50458-254Haldol DecanoateHaloperidol DecanoateJanssen Pharmaceuticals, Inc.NDACurrent
50458-254Haldol DecanoateHaloperidol DecanoateJanssen Pharmaceuticals, Inc.NDACurrent
50458-254Haldol DecanoateHaloperidol DecanoateJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84038SUPPL 2025-11-03
84032SUPPL 2025-10-31
81147SUPPL 2025-02-07
80933SUPPL 2025-02-05
65284SUPPL2020-11-19
65267SUPPL2020-11-18
65266SUPPL2020-11-18
57961SUPPL2019-03-12
57955SUPPL2019-03-12
50630SUPPL2017-12-07
50629SUPPL2017-12-07
47357SUPPL2017-03-02
47356SUPPL2017-02-27
15096SUPPL2016-05-20
11281SUPPL2016-05-20
1029SUPPL2013-05-07
11279SUPPL2011-08-16
1025SUPPL2011-08-15
15095SUPPL2011-03-07
33561SUPPL2011-03-04
1028SUPPL2010-12-06
33560SUPPL2010-12-04
1027SUPPL2009-08-04
11280SUPPL2009-07-23
33559SUPPL2008-08-29
1026SUPPL2008-08-19
33558SUPPL2008-06-05
15094SUPPL2008-05-14
15093SUPPL2007-09-25
20149SUPPL2007-07-06
15092SUPPL2007-05-09
33557SUPPL2007-05-07