Application 020272

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RISPERDALRISPERIDONETABLET;ORAL1MGYesYes
002RISPERDALRISPERIDONETABLET;ORAL2MGYesNo
003RISPERDALRISPERIDONETABLET;ORAL3MGYesNo
004RISPERDALRISPERIDONETABLET;ORAL4MGYesNo
005RISPERDALRISPERIDONETABLET;ORAL5MGNoNo
007RISPERDALRISPERIDONETABLET;ORAL0.5MGYesNo
008RISPERDALRISPERIDONETABLET;ORAL0.25MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020272-001RISPERDALRISPERIDONE1MGTABLET / ORALABRLD, RS1993-12-29
N020272-002RISPERDALRISPERIDONE2MGTABLET / ORALABRLD1993-12-29
N020272-003RISPERDALRISPERIDONE3MGTABLET / ORALABRLD1993-12-29
N020272-004RISPERDALRISPERIDONE4MGTABLET / ORALABRLD1993-12-29
N020272-005RISPERDALRISPERIDONE5MGTABLET / ORAL1993-12-29
N020272-007RISPERDALRISPERIDONE0.5MGTABLET / ORALABRLD1999-01-27
N020272-008RISPERDALRISPERIDONE0.25MGTABLET / ORALABRLD1999-05-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
N020272-001AB
N020272-002AB
N020272-003AB
N020272-004AB
N020272-007AB
N020272-008AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-005RISPERDAL5MGTABLET / ORAL1993-12-2984e616aacf4f…
2026-09-14 22:38:342026-08N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-2784e616aacf4f…
2026-09-14 22:38:342026-08N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-1084e616aacf4f…
2026-08-18 06:07:402026-07N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-005RISPERDAL5MGTABLET / ORAL1993-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-27caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-005RISPERDAL5MGTABLET / ORAL1993-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-005RISPERDAL5MGTABLET / ORAL1993-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-005RISPERDAL5MGTABLET / ORAL1993-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-007RISPERDAL0.5MGTABLET / ORALABRLD1999-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-008RISPERDAL0.25MGTABLET / ORALABRLD1999-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-001RISPERDAL1MGTABLET / ORALABRLD, RS1993-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-002RISPERDAL2MGTABLET / ORALABRLD1993-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-003RISPERDAL3MGTABLET / ORALABRLD1993-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-004RISPERDAL4MGTABLET / ORALABRLD1993-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-005RISPERDAL5MGTABLET / ORAL1993-12-29fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020272-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-004AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-007AB184e616aacf4f…
2026-09-14 22:38:342026-08N020272-008AB184e616aacf4f…
2026-08-18 06:07:402026-07N020272-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020272-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020272-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020272-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020272-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020272-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020272-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020272-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020272-004AB1b8a1b40f171c…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RisperidoneRISPERIDONEJanssen Pharmaceuticals, Inc.701e1cd8-2868-4d29-85a9-a2212c88165f2026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 50458-595
ndc (product): 50458-594
ndc (product): 50458-593
RISPERDALRISPERIDONEJanssen Pharmaceuticals, Inc.7e117c7e-02fc-4343-92a1-230061dfc5e02026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020272
application number: NDA020272

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 131 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-593RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-594RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-594RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-594RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-595RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-595RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
50458-595RisperidonerisperidoneJanssen Pharmaceutical, Inc.NDACurrent
55154-1413risperidonerisperidoneCardinal HealthNDACurrent
55289-463RISPERDALrisperidonePD-Rx Pharmaceuticals, InNDACurrent
55289-463RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-463RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-463RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-463RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-463RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-463RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-463RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-463RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-465RISPERDALrisperidonePD-Rx Pharmaceuticals, InNDACurrent
55289-465RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-465RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-465RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-465RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-465RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-465RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-465RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-465RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-491RISPERDALrisperidonePD-Rx Pharmaceuticals, InNDACurrent
55289-491RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-491RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-491RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-491RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-491RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-491RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-491RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-519RISPERDALrisperidonePD-Rx Pharmaceuticals, InNDACurrent
55289-519RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-519RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-519RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-519RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-519RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-519RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-519RISPERDALrisperidonePD-Rx Pharmaceuticals, Inc.NDACurrent
70518-0159RISPERDALrisperidoneREMEDYREPACK INC.NDACurrent
70518-1763RISPERDALrisperidoneREMEDYREPACK INC.NDACurrent
70518-1763RISPERDALrisperidoneREMEDYREPACK INC.NDACurrent
70518-1763RISPERDALrisperidoneREMEDYREPACK INC.NDACurrent
70518-2160RISPERDALrisperidoneREMEDYREPACK INC.NDACurrent
70518-2160RISPERDALrisperidoneREMEDYREPACK INC.NDACurrent
70518-2161RISPERDALrisperidoneREMEDYREPACK INC.NDACurrent
70518-2161RISPERDALrisperidoneREMEDYREPACK INC.NDACurrent
71610-045RisperidonerisperidoneAphena Pharma Solutions - Tennessee, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83887SUPPL 2025-10-23
83886SUPPL 2025-10-23
81130SUPPL 2025-02-07
81030SUPPL 2025-02-05
72791SUPPL2022-12-05
72783SUPPL2022-12-05
66281SUPPL2021-02-18
66239SUPPL2021-02-17
61842SUPPL2020-02-07
61785SUPPL2020-02-06
57553SUPPL2019-02-13
57360SUPPL2019-01-28
55144SUPPL2018-08-09
55050SUPPL2018-07-30
47420SUPPL2017-03-02
47320SUPPL2017-02-24
34460SUPPL2016-03-03
24714SUPPL2016-03-03
24713SUPPL2014-05-09
34459SUPPL2014-04-29
41261SUPPL2013-06-03
41260SUPPL2013-06-03
24710SUPPL2012-08-03
12408SUPPL2012-08-03
24712SUPPL2012-03-13
44053ORIG2011-12-20
41262SUPPL2011-12-14
20581SUPPL2011-12-14
34458SUPPL2011-09-30
34455SUPPL2011-09-30
24711SUPPL2011-09-28
24707SUPPL2011-09-28
24706SUPPL2011-08-26
12405SUPPL2011-08-25
24709SUPPL2011-06-17
12407SUPPL2011-06-16
41255ORIG2011-02-15
2282SUPPL2010-12-06
12406SUPPL2010-12-04
24708SUPPL2010-09-07
24705SUPPL2010-09-07
2281SUPPL2010-09-07
2279SUPPL2010-09-07
34457SUPPL2010-08-30
34456SUPPL2010-08-30
12404SUPPL2010-08-30
12402SUPPL2010-08-30
41259SUPPL2009-09-16
20579SUPPL2009-09-16
12403SUPPL2009-08-06
2280SUPPL2009-08-06
41258SUPPL2009-01-12
2278SUPPL2008-08-19
20580SUPPL2008-02-19
12401SUPPL2007-08-23
12400SUPPL2007-08-23
24704SUPPL2007-08-22
2277SUPPL2007-08-22
41256SUPPL2007-07-20
20578SUPPL2007-07-20
24702SUPPL2006-10-18
24701SUPPL2006-10-18
12398SUPPL2006-10-11
12397SUPPL2006-10-11
24703SUPPL2005-08-19
12399SUPPL2005-08-19
23969SUPPL2004-11-03
24700SUPPL2004-06-16
12395SUPPL2004-06-16
2273SUPPL2004-06-16
34454SUPPL2003-12-11
24699SUPPL2003-12-11
12396SUPPL2003-12-11
2275SUPPL2003-12-11
24698SUPPL2003-11-28
2276SUPPL2003-11-25
2274SUPPL2002-11-19
24697SUPPL2002-03-03
41257SUPPL1997-10-17
52165SUPPL1900-01-01
52164SUPPL1900-01-01
52163SUPPL1900-01-01
52162SUPPL1900-01-01
52161SUPPL1900-01-01
51647ORIG1900-01-01
51646ORIG1900-01-01
51645ORIG1900-01-01
51644ORIG1900-01-01
51643ORIG1900-01-01