← FDA DRUG APPROVALS

FDA NDA · NDA218390

INGREZZA SPRINKLE

valbenazine

Sponsor: NEUROCRINE

APPLICATION
NDA218390
TYPE
NDA
ORIGINAL APPROVAL
2024-04-30
LATEST ACTION
2026-04-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

INGREZZA SPRINKLE · ReferencePrescription
VALBENAZINE TOSYLATE EQ 80MG BASE · CAPSULE · ORAL
INGREZZA SPRINKLE · ReferencePrescription
VALBENAZINE TOSYLATE EQ 40MG BASE · CAPSULE · ORAL
INGREZZA SPRINKLE · ReferencePrescription
VALBENAZINE TOSYLATE EQ 60MG BASE · CAPSULE · ORAL

Approval history

2026-04-08Labeling · Supplement 3 · standard — Letter ↗AP
2024-04-30Type 3 - New Dosage Form · Original · standard — Label ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →