Details for New Drug Application (NDA): 209510
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NDA 209510 describes BARHEMSYS, which is a drug marketed by Acacia and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the BARHEMSYS profile page.
The generic ingredient in BARHEMSYS is amisulpride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amisulpride profile page.
The generic ingredient in BARHEMSYS is amisulpride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amisulpride profile page.
Summary for 209510
| Tradename: | BARHEMSYS |
| Applicant: | Acacia |
| Ingredient: | amisulpride |
| Patents: | 7 |
Pharmacology for NDA: 209510
| Mechanism of Action | Dopamine D2 Antagonists |
Suppliers and Packaging for NDA: 209510
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BARHEMSYS | amisulpride | SOLUTION;INTRAVENOUS | 209510 | NDA | Acacia Pharma Ltd | 71390-125 | 71390-125-20 | 10 CARTON in 1 PACKAGE (71390-125-20) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-21) / 2 mL in 1 VIAL, SINGLE-DOSE |
| BARHEMSYS | amisulpride | SOLUTION;INTRAVENOUS | 209510 | NDA | Acacia Pharma Ltd | 71390-125 | 71390-125-50 | 10 CARTON in 1 PACKAGE (71390-125-50) / 1 VIAL, SINGLE-DOSE in 1 CARTON (71390-125-51) / 4 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5MG/2ML (2.5MG/ML) | ||||
| Approval Date: | Feb 26, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 26, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,525,033 | Patent Expiration: | Mar 10, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,357,753 | Patent Expiration: | Feb 9, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING | ||||||||
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