Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022567
Company: ABBVIE

• Medication Guide

• Other Important Information from FDA

• Summary Review

Products on NDA 22567

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIIBRYD	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	AB	Yes	Yes
VIIBRYD	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	AB	Yes	No
VIIBRYD	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	AB	Yes	No

Labels for NDA 022567

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2021	SUPPL-22	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022567s022lbl.pdf
09/20/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022567s022lbl.pdf
01/31/2020	SUPPL-21	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022567s021lbl.pdf
01/04/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022567s020lbl.pdf
09/06/2016	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022567s019lbl.pdf
03/16/2015	SUPPL-12	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022567s012lbl.pdf
07/16/2014	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022567s013lbl.pdf
04/07/2014	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022567s011lbl.pdf
12/17/2013	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022567s009lbl.pdf
12/21/2012	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022567s005lbl.pdf
09/21/2011	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022567s001lbl.pdf
01/21/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022567s000lbl.pdf