U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 212295
Company: ACACIA
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
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-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
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-Package Insert Label (PDF)
11/30/2020 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
07/02/2020 ORIG-1 Approval Label (PDF)
Back to Top