Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212295
Company: ACACIA

Products on NDA 212295

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BYFAVO	REMIMAZOLAM BESYLATE	EQ 20MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212295

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
07/02/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice on DEA Scheduling; Date of Approval – October 6, 2020

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
01/13/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)
04/08/2021	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)
11/30/2020	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)

Labels for NDA 212295

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
01/13/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)
04/08/2021	SUPPL-2	Labeling-Package Insert	Label (PDF)
11/30/2020	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)
11/30/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)
07/02/2020	ORIG-1	Approval	Label (PDF)