cobicistat Oral Tablet

Brand(s)
Tybost
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Gilead Sciences, Inc. (2014-10-06)
Oldest Current Product
2014-09-24
License(s)
NDA
RxNORM
ORAL TABLET\COBICISTAT
FDAOB
ORAL\TABLET\COBICISTAT
SPL Active
ORAL\TABLET, FILM COATED\COBICISTAT
SPL Moiety
ORAL\TABLET, FILM COATED\COBICISTAT

product(s) by strength(s)

cobicistat 150 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619581401TybostNDAGilead Sciences, Inc.2014-09-24COBICISTATORALTABLET, FILM COATEDNDA2030943784c35c-e87f-410c-900b-8fd6313c6010

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203094TYBOSTGILEAD SCIENCES INC2014-09-24p8148374, TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKNIETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE, SUBSTANCENEW PRODUCT [2017-09-24]NDA203094_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203094_001RXCOBICISTAT (150MG)ORALTABLETTrue2014-09-24TYBOST

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p8148374 (view patent)2029-09-03NDA203094, NDA203100, NDA205395, NDA206353cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / darunavir Oral Tablet
Atazanavir / cobicistat Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
13784c35c-e87f-410c-900b-8fd6313c6010 (view SPL)These highlights do not include all the information needed to use TYBOST safely and effectively. See full prescribing information for TYBOST. TYBOST (cobicistat) tablets, for oral use Initial U.S. Approval: 2012prescriptionHuman PrescriptionGilead Sciences, Inc.2014-10-061619581401

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