Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 214985
Company: IDORSIA
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) |
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