Application 011188

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COMPAZINE	PROCHLORPERAZINE EDISYLATE	SYRUP;ORAL	EQ 5MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N011188-001	COMPAZINE	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/5ML	SYRUP / ORAL		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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N011188-001	COMPAZINE	EQ 5MG BASE/5ML	SYRUP / ORAL	Approved before 1982	`f41ea6bd6efb…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Caplin Steriles Limited	29f0e68d-4653-472d-bd86-e87a8e2cb529	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Somerset Therapeutics, LLC	d382e3d4-3175-42f2-b9eb-d9a7b97cbbfc	2025-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Cardinal Health 107, LLC	6135944c-3ee2-4491-9704-33f56ad435f4	2025-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	0dc48e66-6081-421b-952b-4867c9c4c794	2025-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Hikma Pharmaceuticals USA Inc.	baf59816-7577-4652-b065-fb6de9e54569	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Civica, Inc.	e3e0c6c5-6b92-40e0-a926-29c64846be93	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	FOSUN PHARMA USA INC	f793cdb3-9fd8-79e1-e053-6394a90ae08b	2024-12-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Gland Pharma Limited	a0fd3d58-7470-4d0f-9e6c-84e92c02a97f	2024-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
prochlorperazine edisylate	PROCHLORPERAZINE EDISYLATE	Avenacy Inc.	fd07a1a3-c0df-4926-9964-07348e45a5fd	2024-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	0338b221-db43-45c9-a829-d970fe6643ab	2024-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Cosette Pharmaceuticals, Inc.	4687b9f5-2d67-4fe0-af4d-2415a42b5292	2024-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
prochlorperazine edisylate	PROCHLORPERAZINE EDISYLATE	Amneal Pharmaceuticals LLC	e913d678-7a5d-4e74-9e9c-1b9a3affd265	2024-11-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Eugia US LLC	24358d03-d06d-4946-8ebd-a62bc15d33c0	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
prochlorperazine edisylate	PROCHLORPERAZINE EDISYLATE	Mylan Institutional LLC	185c1647-06ea-401e-ad1d-8727d77eb827	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	HF Acquisition Co LLC, DBA HealthFirst	e181c18d-32a8-587e-e053-2995a90acc5b	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	Sagent Pharmaceuticals	fed5ed29-7091-4b3c-bf67-64f32cd189bb	2022-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE
PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	Baxter Healthcare Corporation	11cb37c7-01b4-4223-b2ea-a3695639b80b	2021-04-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE EDISYLATE

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
11923	SUPPL	2001-04-03