FDA.reportPublic FDA data

Application 022043

Type
NDA
Sponsor
JANSSEN LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INVEGAPALIPERIDONETABLET, EXTENDED RELEASE; ORAL3MGNoNo
002INVEGAPALIPERIDONETABLET, EXTENDED RELEASE; ORAL6MGNoNo
003INVEGAPALIPERIDONETABLET, EXTENDED RELEASE; ORAL9MGNoNo
004INVEGAPALIPERIDONETABLET, EXTENDED RELEASE; ORAL12MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PALIPERIDONEPALIPERIDONEANI Pharmaceuticals, Inc.bbbaa057-f587-4eb9-a0d2-463dbcd576612026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEBryant Ranch Prepackff5ef11c-5c22-4a8e-89dd-4740f0ebf6342026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEBryant Ranch Prepackf75e884e-1883-45d7-ac9b-4a6c63f2185e2026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEBryant Ranch Prepackf0c13f91-0232-48b0-aa13-121805b8da132026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEBryant Ranch Prepackc7472b50-fa6c-4127-a4b3-3645436274ee2026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEWestminster Pharmaceuticals, LLC1745a460-5e3a-4a1f-8eb3-64bb112f47a42026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEMajor Pharmaceuticals528a962a-4924-4c48-93ce-6ab1f019e52c2026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PALIPERIDONEPALIPERIDONECamber Pharmaceuticals, Inc1cfcad42-da71-457d-b1e1-aee806642d0c2026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONESun Pharmaceutical Industries, Inc.0dc3a9b2-2edf-4fa2-a949-459b4218e7632026-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONENorthStar RxLLC5589ec69-c49c-44a7-9561-bbffeb918d1f2026-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEAjanta Pharma USA Inc.71985eb4-07df-41c9-8b9a-85f39e92b7d02026-03-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEAvKARE018cf3ca-bee9-23a6-e063-6394a90ad9052026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEArchis Pharma LLCe713556e-028e-0f4c-e053-2995a90a9e9f2025-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONECoupler LLC463db841-297f-7692-e063-6394a90a8c142025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEAmerican Health Packagingc6d80cc0-596e-49b9-8216-34e7b01e2df22025-10-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEREMEDYREPACK INC.a5492459-e0a2-4c16-9fff-c886e0b4c7002025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEREMEDYREPACK INC.85cdf6fb-d59f-4231-bd21-c8435df5930d2025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEREMEDYREPACK INC.f13d3678-a861-42ba-be44-0d89f1b66ef32025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PALIPERIDONEPALIPERIDONEEskayef Pharmaceuticals Limitedde95e29f-a030-4777-a601-874500ab8e912025-09-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE
PaliperidonePALIPERIDONEAmneal Pharmaceuticals LLC7b269778-803b-4ce2-a8c0-636fb131d16a2025-09-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PALIPERIDONE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23694ORIG2011-12-22
42399ORIG2009-05-28
16818ORIG2007-05-01
6745ORIG2007-05-01