Application 011127

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COMPAZINE	PROCHLORPERAZINE	SUPPOSITORY;RECTAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	COMPAZINE	PROCHLORPERAZINE	SUPPOSITORY;RECTAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	COMPAZINE	PROCHLORPERAZINE	SUPPOSITORY;RECTAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N011127-001	COMPAZINE	PROCHLORPERAZINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982
N011127-002	COMPAZINE	PROCHLORPERAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982
N011127-003	COMPAZINE	PROCHLORPERAZINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N011127-001	COMPAZINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N011127-002	COMPAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N011127-003	COMPAZINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N011127-001	COMPAZINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N011127-002	COMPAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N011127-003	COMPAZINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011127-001	COMPAZINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011127-002	COMPAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N011127-003	COMPAZINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N011127-001	COMPAZINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N011127-002	COMPAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N011127-003	COMPAZINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prochlorperazine	PROCHLORPERAZINE	Cosette Pharmaceuticals, Inc.	9595346e-76e5-e155-341b-ffaaafb885ab	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE
Compro	PROCHLORPERAZINE	PD-Rx Pharmaceuticals, Inc.	b23b67eb-78b7-48eb-84ff-c95d3ce8683c	2025-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE
Compro	PROCHLORPERAZINE	Padagis US LLC	ea381bc5-0957-4c91-826a-0ff680cebacc	2024-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE
Prochlorperazine	PROCHLORPERAZINE	PharmPak, Inc.	383744db-ba57-478a-8041-2ecc26d3e1ec	2022-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
249	SUPPL	2001-04-03