Home Applications 209510 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 43 .
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.
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 · 78 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 2026-09-14 22:38:34 2026-08 N209510-001 BARHEMSYS 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-02-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209510-002 BARHEMSYS 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-01 84e616aacf4f…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…
Observed Orange Book patent history# Patent history page 1 of 19 · 727 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 2 of 2 · 64 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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