FDA.reportPublic FDA data

Application 011276

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COMPAZINEPROCHLORPERAZINE EDISYLATECONCENTRATE;ORALEQ 10MG BASE/MLNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N011276-001COMPAZINEPROCHLORPERAZINE EDISYLATEEQ 10MG BASE/MLCONCENTRATE / 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N011276-001COMPAZINEEQ 10MG BASE/MLCONCENTRATE / ORALRLD, Approved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECaplin Steriles Limited29f0e68d-4653-472d-bd86-e87a8e2cb5292026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATESomerset Therapeutics, LLCd382e3d4-3175-42f2-b9eb-d9a7b97cbbfc2025-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECardinal Health 107, LLC6135944c-3ee2-4491-9704-33f56ad435f42025-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0dc48e66-6081-421b-952b-4867c9c4c7942025-03-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHikma Pharmaceuticals USA Inc.baf59816-7577-4652-b065-fb6de9e545692025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECivica, Inc.e3e0c6c5-6b92-40e0-a926-29c64846be932025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEFOSUN PHARMA USA INCf793cdb3-9fd8-79e1-e053-6394a90ae08b2024-12-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEGland Pharma Limiteda0fd3d58-7470-4d0f-9e6c-84e92c02a97f2024-12-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
prochlorperazine edisylatePROCHLORPERAZINE EDISYLATEAvenacy Inc.fd07a1a3-c0df-4926-9964-07348e45a5fd2024-12-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0338b221-db43-45c9-a829-d970fe6643ab2024-12-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECosette Pharmaceuticals, Inc.4687b9f5-2d67-4fe0-af4d-2415a42b52922024-12-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
prochlorperazine edisylatePROCHLORPERAZINE EDISYLATEAmneal Pharmaceuticals LLCe913d678-7a5d-4e74-9e9c-1b9a3affd2652024-11-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEEugia US LLC24358d03-d06d-4946-8ebd-a62bc15d33c02024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
prochlorperazine edisylatePROCHLORPERAZINE EDISYLATEMylan Institutional LLC185c1647-06ea-401e-ad1d-8727d77eb8272024-11-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEHF Acquisition Co LLC, DBA HealthFirste181c18d-32a8-587e-e053-2995a90acc5b2024-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATESagent Pharmaceuticalsfed5ed29-7091-4b3c-bf67-64f32cd189bb2022-11-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE
PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEBaxter Healthcare Corporation11cb37c7-01b4-4223-b2ea-a3695639b80b2021-04-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROCHLORPERAZINE EDISYLATE