Application 204147

Type: ANDA
Sponsor: EMCURE PHARMS LTD

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	Yes

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

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
A204147-001	PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204147-001	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 · 41 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	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204147-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RS	2013-10-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A204147-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204147-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204147-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204147-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204147-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204147-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204147-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204147-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204147-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204147-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204147-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204147-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204147-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204147-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204147-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204147-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204147-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204147-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204147-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204147-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204147-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204147-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204147-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204147-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204147-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204147-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204147-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204147-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204147-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204147-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204147-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204147-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204147-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204147-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204147-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204147-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204147-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204147-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204147-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204147-001	AP	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Cardinal Health 107, LLC	6135944c-3ee2-4491-9704-33f56ad435f4	2025-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204147 application number: ANDA204147 ndc (product): 55154-4183
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	0dc48e66-6081-421b-952b-4867c9c4c794	2025-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204147 application number: ANDA204147 ndc (product): 23155-294
prochlorperazine edisylate	PROCHLORPERAZINE EDISYLATE	Avenacy Inc.	fd07a1a3-c0df-4926-9964-07348e45a5fd	2024-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204147 application number: ANDA204147
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	0338b221-db43-45c9-a829-d970fe6643ab	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204147 application number: ANDA204147 ndc (product): 23155-523

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-294	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-294	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-294	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-294	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-497	PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-497	PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-497	PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-523	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-523	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-523	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-523	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
50090-4548	Prochlorperazine Edisylate	Prochlorperazine Edisylate	A-S Medication Solutions	ANDA	Current
50090-4548	Prochlorperazine Edisylate	Prochlorperazine Edisylate	A-S Medication Solutions	ANDA	Current
50090-4548	Prochlorperazine Edisylate	Prochlorperazine Edisylate	A-S Medication Solutions	ANDA	Current
55154-4183	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Cardinal Health	ANDA	Current
55154-4183	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Cardinal Health	ANDA	Current
55154-4183	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Cardinal Health	ANDA	Current
55154-4183	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Cardinal Health 107, LLC	ANDA	Current
55154-4183	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Cardinal Health	ANDA	Current
55154-4183	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Cardinal Health	ANDA	Current
55154-4183	Prochlorperazine Edisylate	Prochlorperazine Edisylate	Cardinal Health	ANDA	Current