← FDA DRUG APPROVALS

FDA NDA · NDA209241

INGREZZA

valbenazine

Sponsor: NEUROCRINE

APPLICATION
NDA209241
TYPE
NDA
ORIGINAL APPROVAL
2017-04-11
LATEST ACTION
2025-02-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2025-02-04Labeling · Supplement 29 · standard — Letter ↗AP
2024-11-22Labeling · Supplement 28 · standard — Letter ↗AP
2023-08-18Efficacy · Supplement 26 · standard — Label ↗AP
2022-08-11Manufacturing (CMC) · Supplement 24 · standard — Label ↗AP
2021-04-23Efficacy · Supplement 20 · standard — Letter ↗AP
2020-04-09Labeling · Supplement 16 · standard — Letter ↗AP
2019-07-15Labeling · Supplement 12 · 901 required — Letter ↗AP
2019-01-10Manufacturing (CMC) · Supplement 6AP
2018-08-10Labeling · Supplement 3 · standard — Letter ↗AP
2017-04-11Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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