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FDA NDA · NDA211964

QELBREE

viloxazine hydrochloride

Sponsor: SUPERNUS PHARMS

APPLICATION
NDA211964
TYPE
NDA
ORIGINAL APPROVAL
2021-04-02
LATEST ACTION
2025-01-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

QELBREE · ReferencePrescription
VILOXAZINE HYDROCHLORIDE EQ 200MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
QELBREE · ReferencePrescription
VILOXAZINE HYDROCHLORIDE EQ 100MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
QELBREE · ReferencePrescription
VILOXAZINE HYDROCHLORIDE EQ 150MG BASE · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2025-01-23Labeling · Supplement 13 · standard — Label ↗AP
2022-04-29Efficacy · Supplement 3 · standard — Label ↗AP
2021-04-02Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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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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