FDA.reportPublic FDA data

Application 207946

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INVEGA TRINZAPALIPERIDONE PALMITATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR273MG/0.875ML (273MG/0.875ML)YesNo
002INVEGA TRINZAPALIPERIDONE PALMITATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR410MG/1.315ML (311.79MG/ML)YesNo
003INVEGA TRINZAPALIPERIDONE PALMITATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR546MG/1.75ML (312MG/ML)YesNo
004INVEGA TRINZAPALIPERIDONE PALMITATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR819MG/2.625ML (312MG/ML)YesYes
005INVEGA HAFYERAPALIPERIDONE PALMITATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR1,092MG/3.5MLYesNo
006INVEGA HAFYERAPALIPERIDONE PALMITATESUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR1,560MG/5MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-606INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-606INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-606INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-606INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-606INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-606INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-606INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-606INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-606INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-607INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-607INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-607INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-607INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-607INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-607INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-607INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-607INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-607INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-608INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-608INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-608INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-608INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-608INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-608INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-608INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-608INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-608INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-609INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-609INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-609INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-609INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-609INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-609INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-609INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-609INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-609INVEGA TRINZApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-611INVEGA HAFYERApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-611INVEGA HAFYERApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-612INVEGA HAFYERApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent
50458-612INVEGA HAFYERApaliperidone palmitateJanssen Pharmaceuticals, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81038SUPPL 2025-02-12
81070SUPPL 2025-02-06
79631SUPPL 2024-09-16
79630SUPPL 2024-09-16
79612SUPPL 2024-09-16
79611SUPPL 2024-09-16
68508SUPPL2021-09-01
68496SUPPL2021-08-31
68342SUPPL2021-08-11
68328SUPPL2021-08-10
66267SUPPL2021-02-17
66263SUPPL2021-02-17
57565SUPPL2019-02-13
57366SUPPL2019-01-28
55564SUPPL2018-09-21
55056SUPPL2018-07-30
47409SUPPL2017-03-02
47317SUPPL2017-02-24
40601SUPPL2016-03-03
10635SUPPL2016-03-03
44965ORIG2016-02-08
23042ORIG2016-02-08
10634ORIG2015-05-21
19975ORIG2015-05-20