← FDA DRUG APPROVALS

FDA NDA · NDA214985

QUVIVIQ

daridorexant

Sponsor: IDORSIA

APPLICATION
NDA214985
TYPE
NDA
ORIGINAL APPROVAL
2022-01-07
LATEST ACTION
2024-09-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

QUVIVIQ · ReferencePrescription
DARIDOREXANT HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
QUVIVIQ · ReferencePrescription
DARIDOREXANT HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL

Approval history

2024-09-30Efficacy · Supplement 11 · standard — Label ↗AP
2024-09-30Labeling · Supplement 12 · standard — Label ↗AP
2024-09-30Efficacy · Supplement 10 · standard — Label ↗AP
2023-10-30Labeling · Supplement 7 · standard — Label ↗AP
2023-10-30Labeling · Supplement 8 · standard — Label ↗AP
2023-06-28Manufacturing (CMC) · Supplement 5AP
2023-03-24Labeling · Supplement 4 · standard — Label ↗AP
2022-11-08Labeling · Supplement 2 · standard — Letter ↗AP
2022-01-07Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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