FDA.reportPublic FDA data

Application 010571

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COMPAZINEPROCHLORPERAZINE MALEATETABLET;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002COMPAZINEPROCHLORPERAZINE MALEATETABLET;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003COMPAZINEPROCHLORPERAZINE MALEATETABLET;ORALEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N010571-001COMPAZINEPROCHLORPERAZINE MALEATEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N010571-002COMPAZINEPROCHLORPERAZINE MALEATEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N010571-003COMPAZINEPROCHLORPERAZINE MALEATEEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N010571-001COMPAZINEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N010571-002COMPAZINEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N010571-003COMPAZINEEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N010571-001COMPAZINEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N010571-002COMPAZINEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N010571-003COMPAZINEEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N010571-001COMPAZINEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N010571-002COMPAZINEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N010571-003COMPAZINEEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N010571-001COMPAZINEEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N010571-002COMPAZINEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N010571-003COMPAZINEEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

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 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prochlorperazine MaleatePROCHLORPERAZINE MALEATEREMEDYREPACK INC.851dddc0-26da-48eb-b039-cd85384ce8642026-09-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine MaleatePROCHLORPERAZINE MALEATEREMEDYREPACK INC.5c1dd0ea-89e9-4317-a83e-5e15da79ca202026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEPreferred Pharmaceuticals Inc.f3adc8a4-2c2b-4d5e-803f-38361966cc682026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
prochlorperazine maleatePROCHLORPERAZINE MALEATEREMEDYREPACK INC.b3c1d53b-702a-4980-973f-7f2e3affea702026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine MaleatePROCHLORPERAZINE MALEATEMajor Pharmaceuticalsd6fc83ad-9cce-4e60-854c-3825313ee60c2026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEREMEDYREPACK INC.5fbf5fc6-a2d9-4e5d-8485-e6e949ca497d2026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine MaleatePROCHLORPERAZINE MALEATEANI Pharmaceuticals, Inc.50ce4381-94ef-49ff-8794-cfde0ee803b42026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEPD-Rx Pharmaceuticals, Inc.fc77a504-4642-47c1-b2e3-c5db11e5816d2026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
prochlorperazine maleatePROCHLORPERAZINE MALEATEAmneal Pharmaceuticals NY LLCa2a48790-0634-4b46-b362-98b7c252836f2026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEBryant Ranch Prepack7e3aa80a-3a5f-4937-b5aa-4ce2aa6ece1b2026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEA-S Medication Solutions8b58b63c-0a75-406b-bb29-acf0a40353bd2026-02-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEGLENMARK PHARMACEUTICALS INC., USA9c806152-70d0-43eb-b183-b51b12b82b312026-01-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine MaleatePROCHLORPERAZINE MALEATENorthwind Health Company, LLC115a4125-07df-9f9b-e063-6394a90a3e492026-01-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATENorthwind Health Company, LLCc524a28e-1e08-4aa6-a9f0-0a3280a3c2132026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATENorthwind Health Company, LLCf2f12ccc-6e51-0a67-e053-2995a90a22bc2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATERedpharm Drug44f278eb-3588-af83-e063-6394a90a73cf2025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEQPharma, Inc.dc692e77-5240-4aa6-8fe9-9ffcbb2672612025-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEPD-Rx Pharmaceuticals, Inc.3b022837-0fcc-d38a-e063-6394a90a0f7f2025-12-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEJubilant Cadista Pharmaceuticals Inc.b05bc20e-cd19-ab40-1ad0-84a115d6d69e2025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATECardinal Health 107, LLC45f56f93-50a7-4cd3-bce2-f97a805566512025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE MALEATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33022SUPPL2005-08-08
11905SUPPL2005-08-08
223SUPPL2001-04-03