← FDA DRUG APPROVALS

FDA NDA · NDA022567

VIIBRYD

vilazodone hydrochloride

Sponsor: ABBVIE

APPLICATION
NDA022567
TYPE
NDA
ORIGINAL APPROVAL
2011-01-21
LATEST ACTION
2024-04-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VIIBRYD · ReferencePrescription
VILAZODONE HYDROCHLORIDE 10MG · TABLET · ORAL
VIIBRYD · ReferencePrescription
VILAZODONE HYDROCHLORIDE 20MG · TABLET · ORAL
VIIBRYD · ReferencePrescription
VILAZODONE HYDROCHLORIDE 40MG · TABLET · ORAL

Approval history

2024-04-19Labeling · Supplement 25 · standard — Letter ↗AP
2023-08-18Labeling · Supplement 24 · standard — Label ↗AP
2021-09-20Labeling · Supplement 22 · 901 required — Letter ↗AP
2020-01-31Efficacy · Supplement 21 · priority — Label ↗AP
2017-01-04Labeling · Supplement 20 · 901 required — Label ↗AP
2016-09-06Labeling · Supplement 19 · 901 required — Label ↗AP
2015-12-16Manufacturing (CMC) · Supplement 16 · standardAP
2015-06-11Manufacturing (CMC) · Supplement 15 · standardAP
2015-03-16Efficacy · Supplement 12 · standard — Letter ↗AP
2014-07-16Labeling · Supplement 13 · 901 required — Letter ↗AP
2014-04-17Manufacturing (CMC) · Supplement 10 · standardAP
2014-04-07Labeling · Supplement 11 · standard — Label ↗AP
2013-12-17Labeling · Supplement 9 · standard — Letter ↗AP
2013-06-08Manufacturing (CMC) · Supplement 8 · standardAP
2013-01-10Manufacturing (CMC) · Supplement 7 · standardAP
2012-12-21Labeling · Supplement 5 · standard — Label ↗AP
2012-12-14Manufacturing (CMC) · Supplement 6 · standardAP
2011-09-21Labeling · Supplement 1 · standard — Letter ↗AP
2011-06-29REMS · Supplement 2 — Letter ↗AP
2011-01-21Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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