FDA.reportPublic FDA data

Application 022264

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INVEGA SUSTENNAPALIPERIDONE PALMITATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR39MG/0.25ML (39MG/0.25ML)YesNo
002INVEGA SUSTENNAPALIPERIDONE PALMITATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR78MG/0.5ML (78MG/0.5ML)YesNo
003INVEGA SUSTENNAPALIPERIDONE PALMITATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR117MG/0.75ML (117MG/0.75ML)YesNo
004INVEGA SUSTENNAPALIPERIDONE PALMITATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR156MG/ML (156MG/ML)YesYes
005INVEGA SUSTENNAPALIPERIDONE PALMITATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR234MG/1.5ML (156MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-560INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-560INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-560INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-560INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-560INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-560INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-561INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-561INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-561INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-561INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-561INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-561INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-562INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-562INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-562INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-562INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-562INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-562INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-563INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-563INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-563INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-563INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-563INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-563INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-564INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-564INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-564INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-564INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-564INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent
50458-564INVEGA SUSTENNApaliperidone palmitateJanssen Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80906SUPPL 2025-03-12
81069SUPPL 2025-02-06
79626SUPPL 2024-09-16
79610SUPPL 2024-09-16
71768SUPPL2022-08-10
71671SUPPL2022-08-01
68346SUPPL2021-08-11
68324SUPPL2021-08-10
66266SUPPL2021-02-17
66262SUPPL2021-02-17
62855SUPPL2020-05-08
57564SUPPL2019-02-13
57365SUPPL2019-01-28
55563SUPPL2018-09-21
55055SUPPL2018-07-30
50924SUPPL2017-12-27
50849SUPPL2017-12-26
48739SUPPL2017-06-16
48738SUPPL2017-06-16
47408SUPPL2017-03-02
47316SUPPL2017-02-24
17169SUPPL2016-03-03
7134SUPPL2016-03-03
17168SUPPL2015-06-11
7133SUPPL2015-06-10
38465SUPPL2014-12-20
17167SUPPL2014-12-20
29493SUPPL2014-11-14
29492SUPPL2014-11-14
17166SUPPL2014-05-02
29491SUPPL2014-05-01
38463SUPPL2012-08-31
29489SUPPL2012-08-30
44177ORIG2011-12-22
38464SUPPL2011-09-30
29490SUPPL2011-09-28
7131SUPPL2011-06-24
38461SUPPL2011-06-16
7132SUPPL2010-12-07
38462SUPPL2010-12-04
7130SUPPL2010-05-18
38460SUPPL2010-05-17
44720ORIG2010-05-13
42473ORIG2010-05-13
17165ORIG2009-10-01
7129ORIG2009-08-17