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Drugs@FDA: FDA-Approved Drugs

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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
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
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)
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