Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211964
Company: SUPERNUS PHARMS

• Medication Guide

Products on NDA 211964

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QELBREE	VILOXAZINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
QELBREE	VILOXAZINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
QELBREE	VILOXAZINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211964

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211964s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211964Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211964Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-3	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211964s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211964Orig1s003ltr.pdf

Labels for NDA 211964

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211964s003lbl.pdf
04/02/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211964s000lbl.pdf