Application 040268

Type: ANDA
Sponsor: JUBILANT CADISTA

Application Products#

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

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
A040268-001	PROCOMP	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27
A040268-002	PROCOMP	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040268-001	AB
A040268-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB		1998-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A040268-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040268-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040268-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040268-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040268-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040268-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040268-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040268-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040268-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040268-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040268-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040268-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040268-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040268-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040268-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040268-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040268-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040268-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040268-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040268-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040268-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040268-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040268-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040268-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040268-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040268-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040268-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040268-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040268-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040268-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040268-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040268-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040268-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040268-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040268-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040268-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040268-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040268-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040268-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040268-002	AB	1	`782e0a99824c…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Sportpharm LLC	3d28dab2-0264-482e-b99d-f56a9314b8a5	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	REMEDYREPACK INC.	5fbf5fc6-a2d9-4e5d-8485-e6e949ca497d	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268 ndc (product): 70518-1620
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	PD-Rx Pharmaceuticals, Inc.	fc77a504-4642-47c1-b2e3-c5db11e5816d	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268 ndc (product): 43063-742
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	7e3aa80a-3a5f-4937-b5aa-4ce2aa6ece1b	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	A-S Medication Solutions	8b58b63c-0a75-406b-bb29-acf0a40353bd	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268 ndc (product): 50090-2241 ndc (product): 50090-2839
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	c524a28e-1e08-4aa6-a9f0-0a3280a3c213	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268 ndc (product): 51655-096
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	f2f12ccc-6e51-0a67-e053-2995a90a22bc	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	QPharma, Inc.	dc692e77-5240-4aa6-8fe9-9ffcbb267261	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268 ndc (product): 42708-103
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Jubilant Cadista Pharmaceuticals Inc.	b05bc20e-cd19-ab40-1ad0-84a115d6d69e	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268 ndc (product): 59746-113 ndc (product): 59746-115
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Cardinal Health 107, LLC	45f56f93-50a7-4cd3-bce2-f97a80556651	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268 ndc (product): 55154-4342
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	AvPAK	86ac7223-b840-bc0c-e053-2991aa0a32f2	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268 ndc (product): 50268-685 ndc (product): 50268-684
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Direct_Rx	02069e43-5245-20dc-e063-6294a90a9dcd	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	664da979-a480-4482-a5a5-0ec98d4c0037	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	NuCare Pharmaceuticals, Inc.	40bd3a0c-368f-64e9-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268 ndc (product): 66267-271
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Proficient Rx LP	565e4b1b-04be-47b4-99b0-903fc2ed47af	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268 ndc (product): 63187-502 ndc (product): 63187-251
Prochlorperazine	PROCHLORPERAZINE	PharmPak, Inc.	383744db-ba57-478a-8041-2ecc26d3e1ec	2022-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268 ndc (product): 54348-989

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 83 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-8190	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	Liberty Pharmaceuticals, Inc.	ANDA	Current
10544-281	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Blenheim Pharmacal, Inc.	ANDA	Current
10544-511	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	Blenheim Pharmacal, Inc.	ANDA	Current
21695-571	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	Rebel Distributors Corp	ANDA	Current
21695-572	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Rebel Distributors Corp	ANDA	Current
33261-141	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	Aidarex Pharmaceuticals LLC	ANDA	Current
33261-550	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Aidarex Pharmaceuticals LLC	ANDA	Current
42291-728	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	AvKARE	ANDA	Current
42291-728	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	AvKARE	ANDA	Current
42291-729	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	AvKARE	ANDA	Current
42291-729	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	AvKARE	ANDA	Current
42708-103	Prochlorperazine maleate	Prochlorperazine maleate	QPharma Inc	ANDA	Current
42708-103	Prochlorperazine maleate	Prochlorperazine maleate	QPharma Inc	ANDA	Current
43063-742	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-742	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-742	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-742	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-742	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-742	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-2241	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	A-S Medication Solutions	ANDA	Current
50090-2241	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	A-S Medication Solutions	ANDA	Current
50090-2242	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	A-S Medication Solutions	ANDA	Current
50090-2242	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	A-S Medication Solutions	ANDA	Current
50090-2242	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	A-S Medication Solutions	ANDA	Current
50090-2242	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	A-S Medication Solutions	ANDA	Current
50090-2839	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	A-S Medication Solutions	ANDA	Current
50090-2839	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	A-S Medication Solutions	ANDA	Current
50090-2839	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	A-S Medication Solutions	ANDA	Current
50268-684	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	AvPAK	ANDA	Current
50268-684	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	AvPAK	ANDA	Current
50268-685	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	AvPAK	ANDA	Current
50268-685	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	AvPAK	ANDA	Current
51655-096	Prochlorperazine Maleate	Prochlorperazine Maleate	Northwind Pharmaceuticals	ANDA	Current
54348-114	PROCHLORPERAZINE	PROCHLORPERAZINE	PharmPak, Inc.	ANDA	Current
54348-114	PROCHLORPERAZINE	PROCHLORPERAZINE	PharmPak, Inc.	ANDA	Current
54348-989	Prochlorperazine	PROCHLORPERAZINE	PharmPak, Inc.	ANDA	Current
54348-989	Prochlorperazine	PROCHLORPERAZINE	PharmPak, Inc.	ANDA	Current
55154-4342	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Cardinal Health	ANDA	Current
55154-4342	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Cardinal Health	ANDA	Current
55154-4342	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Cardinal Health 107, LLC	ANDA	Current
59746-113	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
59746-115	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
61919-327	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	DIRECT RX	ANDA	Current
61919-908	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	DIRECT RX	ANDA	Current
61919-908	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Direct_Rx	ANDA	Current
63187-251	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Proficient Rx LP	ANDA	Current
63187-251	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Proficient Rx LP	ANDA	Current
63187-251	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Proficient Rx LP	ANDA	Current
63187-502	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	Proficient Rx LP	ANDA	Current
63187-502	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	Proficient Rx LP	ANDA	Current
63187-502	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	Proficient Rx LP	ANDA	Current
63629-1841	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	Bryant Ranch Prepack	ANDA	Current
63629-1841	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	Bryant Ranch Prepack	ANDA	Current
66267-271	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-271	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-271	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-271	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-318	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-318	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-826	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-826	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	NuCare Pharmaceuticals,Inc.	ANDA	Current
66336-921	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Dispensing Solutions, Inc.	ANDA	Current
67296-0238	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	RedPharm Drug, Inc.	ANDA	Current
67296-0238	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	RedPharm Drug, Inc.	ANDA	Current
67296-0238	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	RedPharm Drug, Inc.	ANDA	Current
67296-0727	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	RedPharm Drug, Inc.	ANDA	Current
67296-0727	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	RedPharm Drug, Inc.	ANDA	Current
67296-0727	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	RedPharm Drug, Inc.	ANDA	Current
68788-7628	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	JUBILANT CADISTA PHARMACEUTICALS INC.	ANDA	Current
68788-7628	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Preferred Pharmaceuticlas Inc.	ANDA	Current
68788-7628	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Preferred Pharmaceuticlas Inc.	ANDA	Current
70518-1620	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	REMEDYREPACK INC.	ANDA	Current
70518-1620	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	REMEDYREPACK INC.	ANDA	Current
70518-1620	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	REMEDYREPACK INC.	ANDA	Current
70518-1620	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	REMEDYREPACK INC.	ANDA	Current
70518-1620	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	REMEDYREPACK INC.	ANDA	Current
70518-1620	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	REMEDYREPACK INC.	ANDA	Current
70934-405	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-405	PROCHLORPERAZINE MALEATE	Prochlorperazine Maleate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-419	PROCHLORPERAZINE MALEATE	Prochlorperazine maleate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82188	SUPPL	2025-05-15
82128	SUPPL	2025-05-01
42605	ORIG	1998-02-27