← FDA DRUG APPROVALS

FDA NDA · NDA204370

VRAYLAR

cariprazine

Sponsor: ABBVIE

APPLICATION
NDA204370
TYPE
NDA
ORIGINAL APPROVAL
2015-09-17
LATEST ACTION
2025-12-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

VRAYLAR · ReferencePrescription
CARIPRAZINE HYDROCHLORIDE EQ 0.75MG BASE · CAPSULE · ORAL
VRAYLAR · ReferencePrescription
CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE · CAPSULE · ORAL
VRAYLAR · ReferencePrescription
CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE · CAPSULE · ORAL
VRAYLAR · ReferencePrescription
CARIPRAZINE HYDROCHLORIDE EQ 0.5MG BASE · CAPSULE · ORAL
VRAYLAR · ReferencePrescription
CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE · CAPSULE · ORAL
VRAYLAR · ReferencePrescription
CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE · CAPSULE · ORAL

Approval history

2025-12-18Efficacy · Supplement 17 · priority — Letter ↗AP
2025-12-18Efficacy · Supplement 15 · priority — Letter ↗AP
2025-12-18Efficacy · Supplement 16 · priority — Letter ↗AP
2025-12-18Efficacy · Supplement 14 · standard — Letter ↗AP
2024-11-22Labeling · Supplement 12 · standard — Label ↗AP
2022-12-16Efficacy · Supplement 9 · standard — Label ↗AP
2019-05-24Efficacy · Supplement 6 · standard — Label ↗AP
2018-11-28Labeling · Supplement 5 · standard — Letter ↗AP
2017-11-09Labeling · Supplement 3 · standard — Label ↗AP
2017-11-09Efficacy · Supplement 2 · standard — Label ↗AP
2017-02-23Labeling · Supplement 1 · 901 required — Label ↗AP
2015-09-17Type 1 - New Molecular Entity · Original · standard — Label ↗AP
2015-09-17Efficacy · Original · standardAP
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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