Application 083329

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A083329-001	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A083329-001	AP

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083329-001	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A083329-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A083329-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083329-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083329-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083329-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083329-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083329-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083329-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083329-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083329-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083329-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083329-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083329-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083329-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083329-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083329-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083329-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083329-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083329-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083329-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A083329-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083329-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083329-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083329-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083329-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083329-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083329-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083329-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083329-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083329-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083329-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083329-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083329-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083329-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083329-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083329-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083329-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083329-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083329-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A083329-001	AP	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	Henry Schein, Inc.	310d161e-c4db-49e8-8665-d1a6d4e11320	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083329 application number: ANDA083329 ndc (product): 0404-9836
CHLORPROMAZINE HCI	CHLORPROMAZINE HCI	HF Acquisition Co LLC, DBA HealthFirst	9575c766-3758-6f33-e053-2995a90ae6b1	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083329 application number: ANDA083329 ndc (product): 51662-1406
Chlorpromazine hydrochloride	CHLORPROMAZINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	c0f1fcfd-8863-4032-bf80-185df60a4ba0	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083329 application number: ANDA083329 ndc (product): 0641-1398 ndc (product): 0641-1397

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9836	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	Henry Schein, Inc.	ANDA	Current
0404-9836	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	Henry Schein, Inc.	ANDA	Current
0641-1397	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-1397	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-1397	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-1398	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-1398	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-1398	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
51662-1406	CHLORPROMAZINE HCI	CHLORPROMAZINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1406	CHLORPROMAZINE HCI	CHLORPROMAZINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-397	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	ANDA	Current
52584-397	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	ANDA	Current
52584-397	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	ANDA	Current
52584-397	CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	General Injectables and Vaccines, Inc.	ANDA	Current
64725-1397	Chlorpromazine hydrochloride	Chlorpromazine hydrochloride	TYA Pharmaceuticals	ANDA	Current