vilazodone Oral Tablet

Brand(s)
Viibryd
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Forest Laboratories, Inc (2015-03-16)
Oldest Current Product
2011-04-29
License(s)
NDA
RxNORM
ORAL TABLET\VILAZODONE
FDAOB
ORAL\TABLET\VILAZODONE HYDROCHLORIDE
SPL Active
ORAL\TABLET\VILAZODONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\VILAZODONE

product(s) by strength(s)

vilazodone hydrochloride 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004561110ViibrydNDAForest Laboratories, Inc2011-04-29VILAZODONE HYDROCHLORIDEORALTABLETNDA0225674c55ccfb-c4cf-11df-851a-0800200c9a66

vilazodone hydrochloride 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004561120ViibrydNDAForest Laboratories, Inc2011-04-29VILAZODONE HYDROCHLORIDEORALTABLETNDA0225674c55ccfb-c4cf-11df-851a-0800200c9a66

vilazodone hydrochloride 40 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004561140ViibrydNDAForest Laboratories, Inc2011-04-29VILAZODONE HYDROCHLORIDEORALTABLETNDA0225674c55ccfb-c4cf-11df-851a-0800200c9a66

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544624ViibrydNDACardinal Health2011-04-29VILAZODONE HYDROCHLORIDEORALTABLET004561140NDA022567bfef9e19-d0f5-40fa-954c-b73c812eb242

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022567VIIBRYDFOREST LABORATORIES LLC2011-01-21p5532241, SUBSTANCE
p7834020, TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD), SUBSTANCE
p8236804, TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
p8193195, TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
p8673921, SUBSTANCE
CHANGE IN TARGET DOSING TO 20MG TO 40MG ORALLY ONCE DAILY [2018-03-16]
NEW CHEMICAL ENTITY [2016-01-21]
NDA022567_001, NDA022567_002, NDA022567_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022567_001RXVILAZODONE HYDROCHLORIDE (10MG)ORALTABLETTrue2011-01-21VIIBRYD
2NDA022567_002RXVILAZODONE HYDROCHLORIDE (20MG)ORALTABLETFalse2011-01-21VIIBRYD
3NDA022567_003RXVILAZODONE HYDROCHLORIDE (40MG)ORALTABLETFalse2011-01-21VIIBRYD

patent(s)

#idexpiration dateapplication(s)
1p5532241 (view patent)2019-09-29NDA022567
2p7834020 (view patent)2022-06-05NDA022567
3p8193195 (view patent)2022-06-05NDA022567
4p8236804 (view patent)2022-06-05NDA022567
5p8673921 (view patent)2022-06-05NDA022567

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14c55ccfb-c4cf-11df-851a-0800200c9a66 (view SPL)These highlights do not include all the information needed to use VIIBRYD safely and effectively. See full prescribing information for VIIBRYD.VIIBRYD (vilazodone hydrochloride) tablets, for oral useInitial U.S. Approval: 2011prescriptionHuman PrescriptionForest Laboratories, IncPACK2015-03-1611004561110, 004561120, 004561140, 004561100, 004561101
2bfef9e19-d0f5-40fa-954c-b73c812eb242 (view SPL)These highlights do not include all the information needed to use VIIBRYD safely and effectively. See full prescribing information for VIIBRYD.VIIBRYD (vilazodone hydrochloride) tablets, for oral useInitial U.S. Approval: 2011prescriptionHuman PrescriptionCardinal HealthREPACK2015-09-112551544624

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII