Application 217478

Type: ANDA
Sponsor: BIONPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	TABLET;ORAL	EQ 5MG BASE	No	No
002	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	TABLET;ORAL	EQ 10MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217478-001	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB		2023-04-04
A217478-002	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB		2023-04-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A217478-001	AB
A217478-002	AB

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 · 46 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
2026-02-19 14:30 UTC	2026-02	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217478-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217478-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217478-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217478-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217478-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217478-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217478-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217478-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217478-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217478-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217478-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217478-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217478-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217478-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217478-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217478-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217478-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217478-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217478-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217478-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217478-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217478-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217478-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217478-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217478-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217478-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217478-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217478-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217478-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217478-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217478-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217478-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217478-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217478-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217478-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217478-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217478-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217478-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217478-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217478-002	AB	1	`a67488948f0b…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Redpharm Drug	44f278eb-3588-af83-e063-6394a90a73cf	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	A-S Medication Solutions	f387b07a-2d99-4fd5-bcd1-8f04e69b8a39	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Redpharm Drug	3dd03606-1f58-43ac-e063-6294a90a4439	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	REMEDYREPACK INC.	c622550a-4f61-47f7-bc6b-9545d5d4e031	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Preferred Pharmaceuticals Inc.	f3adc8a4-2c2b-4d5e-803f-38361966cc68	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	a826f111-4186-47d3-99c1-a72d75776c4c	2025-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Redpharm Drug	18988af8-545a-3b69-e063-6394a90ae074	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	3ccd11d3-5e5e-4ed8-9b0c-49b0a84535ab	2025-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bionpharma Inc.	052d351a-978b-6fc3-e063-6294a90aef55	2025-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bionpharma Inc.	2cf363d6-b9e4-2c22-e063-6394a90a7649	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	A-S Medication Solutions	86102abe-0b72-4352-95ce-db88d2e14002	2024-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478