Application 009149

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
007	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
011	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
013	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
018	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
020	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
022	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	SYRUP;ORAL	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
024	THORAZINE	CHLORPROMAZINE	SUPPOSITORY;RECTAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
032	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	CONCENTRATE;ORAL	30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
033	THORAZINE	CHLORPROMAZINE	SUPPOSITORY;RECTAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
043	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	CONCENTRATE;ORAL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 11 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N009149-002	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
N009149-007	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
N009149-011	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N009149-013	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
N009149-018	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
N009149-020	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
N009149-022	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD, Approved before 1982
N009149-024	THORAZINE	CHLORPROMAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982
N009149-032	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CONCENTRATE / ORAL	RLD, Approved before 1982
N009149-033	THORAZINE	CHLORPROMAZINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982
N009149-043	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CONCENTRATE / ORAL	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 1 of 12 · 473 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	N009149-002	THORAZINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009149-007	THORAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009149-011	THORAZINE	25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009149-013	THORAZINE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009149-018	THORAZINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009149-020	THORAZINE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009149-022	THORAZINE	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009149-024	THORAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009149-032	THORAZINE	30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CONCENTRATE / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009149-033	THORAZINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009149-043	THORAZINE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CONCENTRATE / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N009149-002	THORAZINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009149-007	THORAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009149-011	THORAZINE	25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009149-013	THORAZINE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009149-018	THORAZINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009149-020	THORAZINE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009149-022	THORAZINE	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009149-024	THORAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009149-032	THORAZINE	30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CONCENTRATE / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009149-033	THORAZINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009149-043	THORAZINE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CONCENTRATE / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009149-002	THORAZINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009149-007	THORAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009149-011	THORAZINE	25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009149-013	THORAZINE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009149-018	THORAZINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009149-020	THORAZINE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009149-022	THORAZINE	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009149-024	THORAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009149-032	THORAZINE	30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CONCENTRATE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009149-033	THORAZINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUPPOSITORY / RECTAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009149-043	THORAZINE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CONCENTRATE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009149-002	THORAZINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009149-007	THORAZINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009149-011	THORAZINE	25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009149-013	THORAZINE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009149-018	THORAZINE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009149-020	THORAZINE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009149-022	THORAZINE	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD, Approved before 1982	`31067a03dcf5…`

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 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	9709ffde-7034-42be-97be-f5f39eeacf72	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	d1d8fd92-bba6-4521-8cea-3e1089ffd951	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	a2ca3aa1-9e3b-4eca-af26-165562cee7bc	2026-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Northstar Rx LLC	2bd42d3a-bf89-4d74-a252-9b914106a570	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	41b86f9d-d7e2-4296-8d88-e8257c7cbed2	2026-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	2122d619-3f5b-48f6-8f0b-7693199abbdb	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	American Health Packaging	85ab0b93-c716-4889-87db-9e76e75df7c7	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Aurobindo Pharma Limited	c2a8b8a3-187f-4000-bde3-b40bb0e5600f	2026-05-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	aa086a21-de85-4b03-af58-49b70acf8cf0	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	d3b09b67-e8da-450d-8a52-b3c40605de26	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	b8137906-946c-455d-87c0-0e130cd9266f	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Saptalis Pharmaceuticals, LLC.	cd8f9e23-d08a-4d96-8fe9-35ab2bc861c8	2026-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	5ae79c1e-f523-4358-9f8b-7382a03d59bc	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	c2a38be8-43e6-4a56-9556-fe3dad412b82	2026-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	c0c5f94c-5f4d-43db-8cc2-ffc8a45b64cf	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	AvPAK	9e8cebc0-7fcf-dca8-e053-2a95a90a3369	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Coupler LLC	472e9a45-4060-3b2a-e063-6294a90a716a	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	c212a2a1-323a-8b61-e053-2995a90a5b04	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Chartwell RX, LLC	e9d6a9e9-ba25-4c25-9b03-25897a3ac5f3	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	Eugia US LLC	07e6144a-b460-4887-b8e2-dd371c14a55c	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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