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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209510
Company: ACACIA

Products on NDA 209510

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BARHEMSYS	AMISULPRIDE	5MG/2ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
BARHEMSYS	AMISULPRIDE	10MG/4ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209510

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209510s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209510Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/209510Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/14/2022	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209510s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209510Orig1s005ltr.pdf
01/05/2022	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209510Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209510Orig1s004ltr.pdf
05/25/2021	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209510s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209510Orig1s003ltr.pdf
09/01/2020	SUPPL-2	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209510Orig1s002Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209510Orig1s002ltr.pdf

Labels for NDA 209510

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/14/2022	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209510s005lbl.pdf
01/05/2022	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209510Orig1s004lbl.pdf
05/25/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209510s003lbl.pdf
09/01/2020	SUPPL-2	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209510Orig1s002Lbl.pdf
02/26/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209510s000lbl.pdf

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