Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218390
Company: NEUROCRINE

• Medication Guide

Products on NDA 218390

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INGREZZA SPRINKLE	VALBENAZINE TOSYLATE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
INGREZZA SPRINKLE	VALBENAZINE TOSYLATE	EQ 60MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
INGREZZA SPRINKLE	VALBENAZINE TOSYLATE	EQ 80MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218390

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2024	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218390Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218390Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218390Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2026	SUPPL-3	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218390Orig1s003ltr.pdf

Labels for NDA 218390

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218390Orig1s000lbl.pdf