Application 080439

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
005	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A080439-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
A080439-002	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
A080439-003	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
A080439-004	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982
A080439-005	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982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 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A080439-001	CHLORPROMAZINE HYDROCHLORIDE	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	A080439-002	CHLORPROMAZINE HYDROCHLORIDE	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	A080439-003	CHLORPROMAZINE HYDROCHLORIDE	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	A080439-004	CHLORPROMAZINE HYDROCHLORIDE	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	A080439-005	CHLORPROMAZINE HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080439-001	CHLORPROMAZINE HYDROCHLORIDE	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	A080439-002	CHLORPROMAZINE HYDROCHLORIDE	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	A080439-003	CHLORPROMAZINE HYDROCHLORIDE	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	A080439-004	CHLORPROMAZINE HYDROCHLORIDE	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	A080439-005	CHLORPROMAZINE HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080439-001	CHLORPROMAZINE HYDROCHLORIDE	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	A080439-002	CHLORPROMAZINE HYDROCHLORIDE	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	A080439-003	CHLORPROMAZINE HYDROCHLORIDE	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	A080439-004	CHLORPROMAZINE HYDROCHLORIDE	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	A080439-005	CHLORPROMAZINE HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080439-001	CHLORPROMAZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080439-002	CHLORPROMAZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080439-003	CHLORPROMAZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080439-004	CHLORPROMAZINE HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080439-005	CHLORPROMAZINE HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080439-001	CHLORPROMAZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080439-002	CHLORPROMAZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080439-003	CHLORPROMAZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080439-004	CHLORPROMAZINE HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080439-005	CHLORPROMAZINE HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080439-001	CHLORPROMAZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080439-002	CHLORPROMAZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080439-003	CHLORPROMAZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080439-004	CHLORPROMAZINE HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080439-005	CHLORPROMAZINE HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080439-001	CHLORPROMAZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080439-002	CHLORPROMAZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080439-003	CHLORPROMAZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080439-004	CHLORPROMAZINE HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080439-005	CHLORPROMAZINE HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080439-001	CHLORPROMAZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080439-002	CHLORPROMAZINE HYDROCHLORIDE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080439-003	CHLORPROMAZINE HYDROCHLORIDE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080439-004	CHLORPROMAZINE HYDROCHLORIDE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080439-005	CHLORPROMAZINE HYDROCHLORIDE	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`

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 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Advagen Pharma Ltd	02c56c39-99bd-44a4-8d9d-9d867c323968	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: chlorpromazine hydrochloride 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 brand name: Chlorpromazine hydrochloride generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	9709ffde-7034-42be-97be-f5f39eeacf72	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlorpromazine Hydrochloride generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine Hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	REMEDYREPACK INC.	d1d8fd92-bba6-4521-8cea-3e1089ffd951	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlorpromazine Hydrochloride 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 brand name: Chlorpromazine Hydrochloride generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Northstar Rx LLC	2bd42d3a-bf89-4d74-a252-9b914106a570	2025-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Chlorpromazine hydrochloride 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 brand name: Chlorpromazine Hydrochloride 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 brand name: Chlorpromazine Hydrochloride 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 brand name: Chlorpromazine hydrochloride 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 brand name: CHLORPROMAZINE HYDROCHLORIDE 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 brand name: CHLORPROMAZINE HYDROCHLORIDE 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 brand name: ChlorproMAZINE Hydrochloride 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 brand name: Chlorpromazine hydrochloride 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 brand name: Chlorpromazine hydrochloride generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Zydus Lifesciences Limited	0ea5e0c6-0062-4be3-96f2-62397da3e77d	2024-06-04		Name fallback brand name: Chlorpromazine hydrochloride 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 brand name: Chlorpromazine hydrochloride 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 brand name: Chlorpromazine Hydrochloride 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 brand name: Chlorpromazine Hydrochloride 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 brand name: Chlorpromazine Hydrochloride generic name: CHLORPROMAZINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-1546	Chlorpromazine	Chlorpromazine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-1547	Chlorpromazine	Chlorpromazine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-1548	Chlorpromazine	Chlorpromazine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current