Atazanavir Oral Powder

Brand(s)
Reyataz
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E.R. Squibb & Sons, L.L.C. (2015-09-24)
Oldest Current Product
2014-12-19
License(s)
NDA
RxNORM
ORAL POWDER\ATAZANAVIR
FDAOB
ORAL\POWDER\ATAZANAVIR SULFATE
SPL Active
ORAL\POWDER\ATAZANAVIR SULFATE
SPL Moiety
ORAL\POWDER\ATAZANAVIR

product(s) by strength(s)

atazanavir 50 mg oral powder

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000033638ReyatazNDAE.R. Squibb & Sons, L.L.C.2014-12-19ATAZANAVIR SULFATEORALPOWDERNDA206352165cff62-b284-4a27-a65d-9ec8a5bfcdd8

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206352REYATAZBRISTOL MYERS SQUIBB CO2014-06-02p5849911, METHOD FOR TREATING HIV-1 INFECTION, SUBSTANCE
p6087383, SUBSTANCE
NEW PATIENT POPULATION [2018-09-24]
PEDIATRIC EXCLUSIVITY [2017-12-02]
PEDIATRIC EXCLUSIVITY [2019-03-24]
NEW PRODUCT [2017-06-02]
NDA206352_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206352_001RXATAZANAVIR SULFATE (EQ 50MG BASE/PACKET)ORALPOWDERTrue2014-06-02REYATAZ

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5849911 (view patent)2017-06-20NDA206352, NDA021567, NDA206353Atazanavir Oral Capsule
Atazanavir / cobicistat Oral Tablet
2p6087383 (view patent)2018-12-21NDA206352, NDA021567, NDA206353Atazanavir Oral Capsule
Atazanavir / cobicistat Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
1165cff62-b284-4a27-a65d-9ec8a5bfcdd8 (view SPL)These highlights do not include all the information needed to use REYATAZ safely and effectively. See full prescribing information for REYATAZ. REYATAZ (atazanavir) capsules, for oral useREYATAZ (atazanavir) oral powderInitial U.S. Approval: 2003prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2015-09-2422000033638, 000033622, 000033624, 000033631Atazanavir Oral Capsule

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