General MedicationsINTRAVENOUSStandard
BARHEMSYS
AMISULPRIDE
Standard Dose
5MG/2ML (2.5MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BARHEMSYS is listed in Drugs@FDA under application 209510 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient AMISULPRIDE Form and strength SOLUTION;INTRAVENOUS - 5MG/2ML (2.5MG/ML) Sponsor ACACIA Submission history Latest submission status date: 2022-09-14 00:00:00.
Structured Monograph
Clinical summary
Approval overview BARHEMSYS is listed in Drugs@FDA under application 209510 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMISULPRIDE Form and strength SOLUTION;INTRAVENOUS - 5MG/2ML (2.5MG/ML) Sponsor ACACIA Submission history Latest submission status date: 2022-09-14 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.