Application 209510

Type: NDA
Sponsor: ACACIA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BARHEMSYS	AMISULPRIDE	SOLUTION;INTRAVENOUS	5MG/2ML (2.5MG/ML)	Yes	Yes
002	BARHEMSYS	AMISULPRIDE	SOLUTION;INTRAVENOUS	10MG/4ML (2.5MG/ML)	Yes	No

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

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
N209510-001	BARHEMSYS	AMISULPRIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-02-26
N209510-002	BARHEMSYS	AMISULPRIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2020-09-01

Orange Book patents#

Current patent rows page 1 of 1 · 32 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209510-001	10525033	2031-03-10		Drug product	2020-03-16
N209510-001	12194022	2031-03-10	U-1744		2025-01-29
N209510-001	12194022	2031-03-10	U-3467		2025-01-29
N209510-001	9545426	2031-03-10	U-1744		2020-03-16
N209510-001	9545426	2031-03-10	U-2754		2020-03-16
N209510-001	9889118	2031-03-10	U-1744		2020-03-16
N209510-001	9889118	2031-03-10	U-2754		2020-03-16
N209510-001	9084765	2034-02-26	U-1744		2020-03-16
N209510-001	9084765	2034-02-26	U-2754		2020-03-16
N209510-001	9084765	2034-02-26	U-3467		2020-03-16
N209510-001	11357753	2038-02-09	U-2754		2022-07-08
N209510-001	12005042	2038-02-09	U-1744		2025-01-08
N209510-001	12005042	2038-02-09	U-2754		2025-01-08
N209510-001	12005042	2038-02-09	U-3467		2025-01-08
N209510-001	12329740	2038-02-09	U-2754		2025-07-02
N209510-001	12329740	2038-02-09	U-3467		2025-07-02
N209510-002	10525033	2031-03-10		Drug product	2022-02-09
N209510-002	12194022	2031-03-10	U-1744		2025-01-29
N209510-002	12194022	2031-03-10	U-3467		2025-01-29
N209510-002	9545426	2031-03-10	U-1744		2022-02-09
N209510-002	9545426	2031-03-10	U-2754		2022-02-09
N209510-002	9889118	2031-03-10	U-1744		2022-02-09
N209510-002	9889118	2031-03-10	U-2754		2022-02-09
N209510-002	9084765	2034-02-26	U-1744		2022-02-09
N209510-002	9084765	2034-02-26	U-2754		2022-02-09
N209510-002	9084765	2034-02-26	U-3467		2022-02-09
N209510-002	11357753	2038-02-09	U-2754		2022-07-08
N209510-002	12005042	2038-02-09	U-1744		2025-01-08
N209510-002	12005042	2038-02-09	U-2754		2025-01-08
N209510-002	12005042	2038-02-09	U-3467		2025-01-08
N209510-002	12329740	2038-02-09	U-2754		2025-07-02
N209510-002	12329740	2038-02-09	U-3467		2025-07-02

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 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209510-001	BARHEMSYS	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-02-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209510-002	BARHEMSYS	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-09-01	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 695 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209510-001	10525033	2031-03-10		Drug product	2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12194022	2031-03-10	U-1744		2025-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12194022	2031-03-10	U-3467		2025-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9545426	2031-03-10	U-1744		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9545426	2031-03-10	U-2754		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9889118	2031-03-10	U-2754		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9889118	2031-03-10	U-1744		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9084765	2034-02-26	U-1744		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9084765	2034-02-26	U-2754		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	9084765	2034-02-26	U-3467		2020-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	11357753	2038-02-09	U-2754		2022-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12005042	2038-02-09	U-1744		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12005042	2038-02-09	U-3467		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12005042	2038-02-09	U-2754		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12329740	2038-02-09	U-2754		2025-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-001	12329740	2038-02-09	U-3467		2025-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	10525033	2031-03-10		Drug product	2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12194022	2031-03-10	U-1744		2025-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12194022	2031-03-10	U-3467		2025-01-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9545426	2031-03-10	U-2754		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9545426	2031-03-10	U-1744		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9889118	2031-03-10	U-2754		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9889118	2031-03-10	U-1744		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9084765	2034-02-26	U-1744		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9084765	2034-02-26	U-2754		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	9084765	2034-02-26	U-3467		2022-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	11357753	2038-02-09	U-2754		2022-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12005042	2038-02-09	U-3467		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12005042	2038-02-09	U-2754		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12005042	2038-02-09	U-1744		2025-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12329740	2038-02-09	U-2754		2025-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209510-002	12329740	2038-02-09	U-3467		2025-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209510-001	10525033	2031-03-10		Drug product	2020-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	12194022	2031-03-10	U-1744		2025-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	12194022	2031-03-10	U-3467		2025-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	9545426	2031-03-10	U-1744		2020-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	9545426	2031-03-10	U-2754		2020-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	9889118	2031-03-10	U-2754		2020-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	9889118	2031-03-10	U-1744		2020-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209510-001	9084765	2034-02-26	U-1744		2020-03-16	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209510-001	NCE	2025-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209510-002	NCE	2025-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209510-001	NCE	2025-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209510-002	NCE	2025-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209510-001	NCE	2025-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209510-002	NCE	2025-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209510-001	NCE	2025-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209510-002	NCE	2025-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209510-001	NCE	2025-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209510-002	NCE	2025-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209510-001	NCE	2025-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209510-002	NCE	2025-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209510-001	NCE	2025-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209510-002	NCE	2025-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209510-001	NCE	2025-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209510-002	NCE	2025-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209510-001	NCE	2025-02-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209510-002	NCE	2025-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209510-001	NCE	2025-02-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209510-002	NCE	2025-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209510-001	NCE	2025-02-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209510-002	NCE	2025-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209510-001	NCE	2025-02-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209510-002	NCE	2025-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209510-001	NCE	2025-02-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209510-002	NCE	2025-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209510-001	NCE	2025-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209510-002	NCE	2025-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209510-001	NCE	2025-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209510-002	NCE	2025-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209510-001	NCE	2025-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209510-002	NCE	2025-02-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209510-001	NCE	2025-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209510-001	NCE	2025-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209510-001	NCE	2025-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209510-001	NCE	2025-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209510-001	NCE	2025-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209510-001	NCE	2025-02-26	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209510-001	NCE	2025-02-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209510-002	NCE	2025-02-26	`6a51e52b5d6a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Barhemsys	AMISULPRIDE	Acacia Pharma Ltd	ab23bc6e-b6a8-165f-e053-2a95a90ab144	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209510 application number: NDA209510 ndc (product): 71390-125

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
71390-125	Barhemsys	Amisulpride	Acacia Pharma Ltd	NDA	Current
71390-125	Barhemsys	Amisulpride	Acacia Pharma Ltd	NDA	Current
71390-125	Barhemsys	Amisulpride	Acacia Pharma Ltd	NDA	Current
71390-125	Barhemsys	Amisulpride	Acacia Pharma Ltd	NDA	Current
71390-125	Barhemsys	Amisulpride	Acacia Pharma Ltd	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72084	SUPPL	2022-09-15
72081	SUPPL	2022-09-15
69816	SUPPL	2022-01-06
69815	SUPPL	2022-01-06
67604	SUPPL	2021-05-27
67600	SUPPL	2021-05-26
65973	SUPPL	2021-01-25
65968	SUPPL	2021-01-25
62356	ORIG	2020-03-30
61983	ORIG	2020-02-27
61975	ORIG	2020-02-26