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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 022567

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022567

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/21/2011	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022567s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022567s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022567Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022567Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2024	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022567s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020822Orig1s055; 021365Orig1s041; 021323Orig1s058; 022567Orig1s025; 204168Orig1s012ltr.pdf
08/18/2023	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022567s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204168Orig1s011,022567Orig1s024ltr.pdf
09/20/2021	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022567s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020822Orig1s052, 021365Orig1s038, 021323Orig1s053, 022567Orig1s022, 204168Orig1s007ltr.pdf
01/31/2020	SUPPL-21	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022567s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022567Orig1s021ltr.pdf
01/04/2017	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022567s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020822Orig1s047,021323Orig1s047,021365Orig1s035,022567Orig1s020ltr.pdf
09/06/2016	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022567s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022567Orig1s019ltr.pdf
12/16/2015	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/11/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
07/16/2014	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022567s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022567Orig1s013ltr.pdf
03/16/2015	SUPPL-12	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022567s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022567Orig1s012ltr.pdf
04/07/2014	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022567s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022567Orig1s011ltr.pdf
04/17/2014	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/17/2013	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022567s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022567Orig1s009ltr.pdf
06/08/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
01/10/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/14/2012	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/21/2012	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022567s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022567Orig1s005ltr.pdf
06/29/2011	SUPPL-2	REMS-Assessment, REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022567s002ltr.pdf
09/21/2011	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022567s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022567s001ltr.pdf

Labels for NDA 022567

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2024	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022567s025lbl.pdf
08/18/2023	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022567s024lbl.pdf
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

Therapeutic Equivalents for NDA 022567

VIIBRYD

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VIIBRYD	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	Yes	AB	022567	ABBVIE
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208209	ACCORD HLTHCARE
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208202	ALEMBIC
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208228	APOTEX
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208200	INVAGEN PHARMS
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208212	TEVA PHARMS USA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VIIBRYD	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	Yes	AB	022567	ABBVIE
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	208209	ACCORD HLTHCARE
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	208202	ALEMBIC
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	208228	APOTEX
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	208200	INVAGEN PHARMS
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	208212	TEVA PHARMS USA

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VIIBRYD	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	Yes	AB	022567	ABBVIE
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	208209	ACCORD HLTHCARE
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	208202	ALEMBIC
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	208228	APOTEX
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	208200	INVAGEN PHARMS
VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE	40MG	TABLET;ORAL	Prescription	No	AB	208212	TEVA PHARMS USA

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