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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214985
Company: IDORSIA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUVIVIQ DARIDOREXANT HYDROCHLORIDE EQ 25MG BASE TABLET;ORAL Prescription None Yes No
QUVIVIQ DARIDOREXANT HYDROCHLORIDE EQ 50MG BASE 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
01/07/2022 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Federal Register Notice (PDF)
Label (PDF)
Letter (PDF)
Review
FR Notice on DEA Scheduling Date of Approval – April 7, 2022
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note
11/08/2022 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note
11/08/2022 SUPPL-2 Labeling-Package Insert Label (PDF)
11/08/2022 SUPPL-2 Labeling-Medication Guide Label (PDF)
01/07/2022 ORIG-1 Approval Label (PDF)
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