Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022567
Company: ALLERGAN
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 ALLERGAN
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 ALLERGAN
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 ALLERGAN
VILAZODONE HYDROCHLORIDE VILAZODONE HYDROCHLORIDE 40MG TABLET;ORAL Prescription No AB 208212 TEVA PHARMS USA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English