Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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 Label (PDF)
Letter (PDF)
Review
Date of Approval; DEA Scheduling Not Complete
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note
01/07/2022 ORIG-1 Approval Label (PDF)

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English