Application 021019

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COMPAZINE	PROCHLORPERAZINE MALEATE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 10MG BASE	No	No
002	COMPAZINE	PROCHLORPERAZINE MALEATE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 15MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021019-001	COMPAZINE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			1999-10-06
N021019-002	COMPAZINE	PROCHLORPERAZINE MALEATE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			1999-10-06

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 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021019-001	COMPAZINE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021019-002	COMPAZINE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	1999-10-06	`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 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	REMEDYREPACK INC.	851dddc0-26da-48eb-b039-cd85384ce864	2026-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	REMEDYREPACK INC.	5c1dd0ea-89e9-4317-a83e-5e15da79ca20	2026-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Preferred Pharmaceuticals Inc.	f3adc8a4-2c2b-4d5e-803f-38361966cc68	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
prochlorperazine maleate	PROCHLORPERAZINE MALEATE	REMEDYREPACK INC.	b3c1d53b-702a-4980-973f-7f2e3affea70	2026-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Major Pharmaceuticals	d6fc83ad-9cce-4e60-854c-3825313ee60c	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	REMEDYREPACK INC.	5fbf5fc6-a2d9-4e5d-8485-e6e949ca497d	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	ANI Pharmaceuticals, Inc.	50ce4381-94ef-49ff-8794-cfde0ee803b4	2026-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	PD-Rx Pharmaceuticals, Inc.	fc77a504-4642-47c1-b2e3-c5db11e5816d	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
prochlorperazine maleate	PROCHLORPERAZINE MALEATE	Amneal Pharmaceuticals NY LLC	a2a48790-0634-4b46-b362-98b7c252836f	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	7e3aa80a-3a5f-4937-b5aa-4ce2aa6ece1b	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	A-S Medication Solutions	8b58b63c-0a75-406b-bb29-acf0a40353bd	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	GLENMARK PHARMACEUTICALS INC., USA	9c806152-70d0-43eb-b183-b51b12b82b31	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	115a4125-07df-9f9b-e063-6394a90a3e49	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	c524a28e-1e08-4aa6-a9f0-0a3280a3c213	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	f2f12ccc-6e51-0a67-e053-2995a90a22bc	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Redpharm Drug	44f278eb-3588-af83-e063-6394a90a73cf	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	QPharma, Inc.	dc692e77-5240-4aa6-8fe9-9ffcbb267261	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	PD-Rx Pharmaceuticals, Inc.	3b022837-0fcc-d38a-e063-6394a90a0f7f	2025-12-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Jubilant Cadista Pharmaceuticals Inc.	b05bc20e-cd19-ab40-1ad0-84a115d6d69e	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Cardinal Health 107, LLC	45f56f93-50a7-4cd3-bce2-f97a80556651	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name 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
Document	Submission type	Date
4073	SUPPL	2001-04-03
35911	ORIG	1999-10-06
26514	ORIG	1999-10-06
21356	ORIG	1999-10-06