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

NDC Listings For This Application#

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