Application 089903

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	INJECTABLE;INJECTION	EQ 5MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A089903-001	PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		1989-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089903-001	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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089903-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	1989-08-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A089903-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089903-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089903-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089903-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089903-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089903-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089903-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089903-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089903-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089903-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089903-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089903-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089903-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089903-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089903-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089903-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089903-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089903-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089903-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089903-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089903-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089903-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089903-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089903-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089903-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089903-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089903-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089903-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089903-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089903-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089903-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089903-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089903-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089903-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089903-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089903-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089903-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089903-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089903-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089903-001	AP	1	`e64feba35796…`

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
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Hikma Pharmaceuticals USA Inc.	baf59816-7577-4652-b065-fb6de9e54569	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089903 application number: ANDA089903 ndc (product): 0641-6135
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Civica, Inc.	e3e0c6c5-6b92-40e0-a926-29c64846be93	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089903 application number: ANDA089903 ndc (product): 72572-580
PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	HF Acquisition Co LLC, DBA HealthFirst	e181c18d-32a8-587e-e053-2995a90acc5b	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089903 application number: ANDA089903 ndc (product): 51662-1558

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-0491	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Baxter Healthcare Corporation	ANDA	Current
0641-6135	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6135	Prochlorperazine Edisylate	Prochlorperazine Edisylate	West-Ward Pharmaceuticals Corp.	ANDA	Current
51662-1558	PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
72572-580	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Civica, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53905	ORIG	2018-05-01
39606	SUPPL	2013-01-09