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CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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CHLORPROMAZINE HYDROCHLORIDE	SYRUP;ORAL	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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THORAZINE	CHLORPROMAZINE	SUPPOSITORY;RECTAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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HYDROCHLORIDE	CONCENTRATE;ORAL	30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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THORAZINE	CHLORPROMAZINE	SUPPOSITORY;RECTAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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HYDROCHLORIDE	CONCENTRATE;ORAL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 2 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	Zydus Lifesciences Limited	d37a4c21-b503-4791-a4d0-2ccc8891d88e	2025-11-04		Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	Henry Schein, Inc.	310d161e-c4db-49e8-8665-d1a6d4e11320	2025-10-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Advagen Pharma Ltd	02c56c39-99bd-44a4-8d9d-9d867c323968	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Piramal Critical Care Inc.	251ee159-bcf1-01f6-e063-6394a90aa414	2025-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Lannett Company, Inc.	1049538a-c012-41bf-932e-3c85f57f9577	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Sandoz, Inc.	9398a0b4-e08b-4eb7-9f31-97d4f384427a	2025-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Coupler LLC	35a743a1-5354-2c50-e063-6394a90a15f9	2025-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Devatis, Inc.	b73b9044-7132-41b7-83d4-2d135ea831f1	2025-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	6564346c-661c-41cf-9cef-db6aa15710cd	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	5831e15a-3efa-48bb-9d49-8451f78d9868	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
ChlorproMAZINE Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Zameer Pharmaceuticals LLC	da3c2935-817d-4331-83c3-ed68ba5d35fd	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Gland Pharma Limited	867d5c7f-52d4-4794-b1d4-6747f3262fba	2024-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	fc2bd95d-a7bc-4ab5-bffa-f5059cb8eb63	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Zydus Lifesciences Limited	0ea5e0c6-0062-4be3-96f2-62397da3e77d	2024-06-04		Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	c0f1fcfd-8863-4032-bf80-185df60a4ba0	2024-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	a6065ac5-a111-449b-b51b-8bc2907d1ddb	2023-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	7cd6dc0d-e98d-40ae-80d4-c15f63056abf	2023-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Novadoz Pharmaceuticals LLC	315ce03f-d9f8-4f3a-9e83-922747430c23	2022-02-09	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.