Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214985
Company: IDORSIA

• Medication Guide

Products on NDA 214985

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214985

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
09/30/2024	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)
09/30/2024	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)
09/30/2024	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)
10/30/2023	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)
10/30/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)
06/28/2023	SUPPL-5	Labeling-Container/Carton Labels		Label is not available on this site.
03/24/2023	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF)
11/08/2022	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)

Labels for NDA 214985

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
09/30/2024	SUPPL-12	Labeling-Package Insert	Label (PDF)
09/30/2024	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)
09/30/2024	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)
10/30/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)
10/30/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)
03/24/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)
03/24/2023	SUPPL-4	Labeling-Medication Guide	Label (PDF)
11/08/2022	SUPPL-2	Labeling-Medication Guide	Label (PDF)
11/08/2022	SUPPL-2	Labeling-Package Insert	Label (PDF)
01/07/2022	ORIG-1	Approval	Label (PDF)