An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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-Package Insert, Labeling-Medication Guide	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-Modified, REMS-Assessment	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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022567s022lbl.pdf
09/20/2021	SUPPL-22	Labeling-Medication Guide	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

Top