FDA.reportPublic FDA data

Application 021999

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INVEGAPALIPERIDONETABLET, EXTENDED RELEASE;ORAL3MGYesNo
002INVEGAPALIPERIDONETABLET, EXTENDED RELEASE;ORAL6MGYesYes
003INVEGAPALIPERIDONETABLET, EXTENDED RELEASE;ORAL9MGYesNo
004INVEGAPALIPERIDONETABLET, EXTENDED RELEASE;ORAL12MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
006INVEGAPALIPERIDONETABLET, EXTENDED RELEASE;ORAL1.5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10147-0951PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0951PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0951PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0951PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0951PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0952PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0952PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0952PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0952PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0952PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0953PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0953PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0953PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0953PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0953PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0954PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0954PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0954PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0954PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
10147-0954PaliperidonepaliperidonePatriot Pharmaceuticals, LLCNDACurrent
21695-455INVEGApaliperidoneRebel Distributors CorpNDACurrent
50458-550INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-550INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-550INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-550INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-550INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-550INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-550INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-550INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-551INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-551INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-551INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-551INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-551INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-551INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-551INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-551INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-552INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-552INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-552INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-552INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-552INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-552INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-552INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-552INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-554INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-554INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-554INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-554INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-554INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-554INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-554INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
50458-554INVEGApaliperidoneJanssen Pharmaceuticals, Inc.NDACurrent
64725-0550INVEGApaliperidoneTYA PharmaceuticalsNDACurrent
70518-0850PaliperidonepaliperidoneREMEDYREPACK INC.NDACurrent
70518-0850PaliperidonepaliperidoneREMEDYREPACK INC.NDACurrent
70518-2034PaliperidonepaliperidoneREMEDYREPACK INC.NDACurrent
70518-2197PaliperidonepaliperidoneREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80905SUPPL 2025-03-12
80903SUPPL 2025-03-12
81067SUPPL 2025-02-06
81066SUPPL 2025-02-06
70747SUPPL2022-04-11
66265SUPPL2021-02-17
66261SUPPL2021-02-17
57562SUPPL2019-02-13
57364SUPPL2019-01-28
55562SUPPL2018-09-21
55054SUPPL2018-07-30
49484SUPPL2017-08-21
49462SUPPL2017-08-18
47407SUPPL2017-03-02
47315SUPPL2017-02-24
29035SUPPL2016-03-03
16733SUPPL2016-03-03
42380SUPPL2014-08-05
38057SUPPL2014-05-02
29034SUPPL2014-05-01
23688ORIG2011-12-22
29032SUPPL2011-04-11
6652SUPPL2011-04-11
38056SUPPL2011-04-07
16732SUPPL2011-04-07
16729SUPPL2011-02-24
6651SUPPL2011-02-18
29033SUPPL2010-12-07
16731SUPPL2010-12-04
29031SUPPL2010-03-11
16730SUPPL2010-03-05
16726SUPPL2009-11-04
29030SUPPL2009-08-06
6649SUPPL2009-08-06
38055SUPPL2009-08-04
16727SUPPL2009-08-04
16728SUPPL2009-07-23
6650SUPPL2009-07-23
38052SUPPL2008-09-05
6647SUPPL2008-09-05
38053SUPPL2008-08-29
38051SUPPL2008-08-29
29029SUPPL2008-08-28
29027SUPPL2008-08-28
38054SUPPL2008-08-26
6648SUPPL2008-08-19
29028SUPPL2008-05-21
29026SUPPL2008-01-09
6646SUPPL2008-01-09
38050SUPPL2008-01-08
42379ORIG2007-03-30
38049ORIG2006-12-28
29025ORIG2006-12-28
64033ORIG1900-01-01
64032ORIG1900-01-01
64031ORIG1900-01-01
53364ORIG1900-01-01
53363ORIG1900-01-01
53362ORIG1900-01-01