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): 212028
Company: EISAI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAYVIGO LEMBOREXANT 5MG TABLET;ORAL Prescription None Yes No
DAYVIGO LEMBOREXANT 10MG TABLET;ORAL 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
12/20/2019 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 – April 7, 2020
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note
04/20/2023 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
01/25/2023 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
03/11/2022 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
08/25/2020 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note
04/20/2023 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
01/25/2023 SUPPL-7 Labeling-Package Insert Label (PDF)
03/11/2022 SUPPL-6 Labeling-Package Insert Label (PDF)
08/25/2020 SUPPL-2 Labeling-Package Insert Label (PDF)
12/20/2019 ORIG-1 Approval Label (PDF)
Back to Top