dolutegravir Oral Tablet

Brand(s)
Tivicay
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Viiv Healthcare Company (2015-08-06)
Oldest Current Product
2013-08-13
License(s)
NDA
RxNORM
ORAL TABLET\DOLUTEGRAVIR
FDAOB
ORAL\TABLET\DOLUTEGRAVIR SODIUM
SPL Active
ORAL\TABLET, FILM COATED\DOLUTEGRAVIR SODIUM
SPL Moiety
ORAL\TABLET, FILM COATED\DOLUTEGRAVIR

product(s) by strength(s)

dolutegravir 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1497020228TivicayNDAViiv Healthcare Company2013-08-13DOLUTEGRAVIR SODIUMORALTABLET, FILM COATEDNDA20479063df5af3-b8ac-4e76-9830-2dbb340af922

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204790TIVICAYVIIV HEALTHCARE CO2013-08-12p8129385, SUBSTANCENEW CHEMICAL ENTITY [2018-08-12]
UPDATE TO LABELING WITH WEEK 48 RESULTS FROM VIKING-4 IN ANTIRETROVIRAL THERAPY (ART) - EXPERIENCED INTEGRASE STRAND TRANSFER INHIBITOR (INSTI) - RESISTANT SUBJECTS [2018-07-30]
NDA204790_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204790_001RXDOLUTEGRAVIR SODIUM (EQ 50MG BASE)ORALTABLETTrue2013-08-12TIVICAY

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p8129385 (view patent)2027-10-05NDA204790, NDA205551abacavir / dolutegravir / Lamivudine Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
163df5af3-b8ac-4e76-9830-2dbb340af922 (view SPL)These highlights do not include all the information needed to use TIVICAY safely and effectively. See full prescribing information for TIVICAY.TIVICAY (dolutegravir) tablets, for oral useInitial U.S. Approval: 2013prescriptionHuman PrescriptionViiv Healthcare Company2015-08-067497020228

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