← FDA DRUG APPROVALS

FDA NDA · NDA209510

BARHEMSYS

amisulpride

Sponsor: LXO IRELAND

APPLICATION
NDA209510
TYPE
NDA
ORIGINAL APPROVAL
2020-02-26
LATEST ACTION
2022-09-14
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BARHEMSYS · ReferencePrescription
AMISULPRIDE 10MG/4ML (2.5MG/ML) · SOLUTION · INTRAVENOUS
BARHEMSYS · ReferencePrescription
AMISULPRIDE 5MG/2ML (2.5MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2022-09-14Labeling · Supplement 5 · standard — Label ↗AP
2022-01-05Labeling · Supplement 4 · standard — Label ↗AP
2021-05-25Labeling · Supplement 3 · standard — Letter ↗AP
2020-09-01Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2020-02-26Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →