FDA.reportPublic FDA data

Application 205402

Type
ANDA
Sponsor
I3 PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALIPERIDONEPALIPERIDONETABLET, EXTENDED RELEASE;ORAL1.5MGNoNo
002PALIPERIDONEPALIPERIDONETABLET, EXTENDED RELEASE;ORAL3MGNoNo
003PALIPERIDONEPALIPERIDONETABLET, EXTENDED RELEASE;ORAL6MGNoNo
004PALIPERIDONEPALIPERIDONETABLET, EXTENDED RELEASE;ORAL9MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205402-001PALIPERIDONEPALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORALAB2026-05-07
A205402-002PALIPERIDONEPALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORALAB2026-05-07
A205402-003PALIPERIDONEPALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORALAB2026-05-07
A205402-004PALIPERIDONEPALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORALAB2026-05-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A205402-001AB
A205402-002AB
A205402-003AB
A205402-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205402-001PALIPERIDONE1.5MGTABLET, EXTENDED RELEASE / ORALAB2026-05-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205402-002PALIPERIDONE3MGTABLET, EXTENDED RELEASE / ORALAB2026-05-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205402-003PALIPERIDONE6MGTABLET, EXTENDED RELEASE / ORALAB2026-05-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205402-004PALIPERIDONE9MGTABLET, EXTENDED RELEASE / ORALAB2026-05-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205402-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205402-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205402-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205402-004AB1a50c72e98297…

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