Atazanavir / cobicistat Oral Tablet

Brand(s)
Evotaz
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E.R. Squibb & Sons, L.L.C. (2015-06-01)
Oldest Current Product
2015-01-29
License(s)
NDA
RxNORM
ORAL TABLET\ATAZANAVIR:COBICISTAT
FDAOB
ORAL\TABLET\ATAZANAVIR SULFATE: COBICISTAT
SPL Active
ORAL\TABLET\ATAZANAVIR SULFATE: COBICISTAT
SPL Moiety
ORAL\TABLET\ATAZANAVIR: COBICISTAT

product(s) by strength(s)

atazanavir 300 mg / cobicistat 150 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000033641EvotazNDAE.R. Squibb & Sons, L.L.C.2015-01-29ATAZANAVIR SULFATE, COBICISTATORALTABLETNDA20635383db29d7-5d85-49d6-8cb6-740473365cf8

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA206353EVOTAZBRISTOL MYERS SQUIBB2015-01-29p8148374, TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKNIETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE, SUBSTANCE
p5849911, METHOD FOR TREATING HIV-1 INFECTION, SUBSTANCE
p6087383, SUBSTANCE
NDA206353_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206353_001RXCOBICISTAT (150MG), ATAZANAVIR SULFATE (EQ 300MG BASE)ORALTABLETTrue2015-01-29EVOTAZ

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5849911 (view patent)2017-06-20NDA206353, NDA021567, NDA206352Atazanavir Oral Powder
Atazanavir Oral Capsule
2p6087383 (view patent)2018-12-21NDA206353, NDA021567, NDA206352Atazanavir Oral Powder
Atazanavir Oral Capsule
3p8148374 (view patent)2029-09-03NDA206353, NDA203094, NDA203100, NDA205395cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat Oral Tablet
cobicistat / darunavir Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
183db29d7-5d85-49d6-8cb6-740473365cf8 (view SPL)These highlights do not include all the information needed to use EVOTAZ safely and effectively. See full prescribing information for EVOTAZ. EVOTAZ (atazanavir and cobicistat) tablet, for oral useInitial U.S. Approval: 2015prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2015-06-013000033641

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