tenofovir disoproxil Oral Powder

Brand(s)
Viread
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Gilead Sciences, Inc. (2015-06-02)
Oldest Current Product
2012-01-18
License(s)
NDA
RxNORM
ORAL POWDER\TENOFOVIR DISOPROXIL
FDAOB
ORAL\POWDER\TENOFOVIR DISOPROXIL FUMARATE
SPL Active
ORAL\POWDER\TENOFOVIR DISOPROXIL FUMARATE
SPL Moiety
ORAL\POWDER\TENOFOVIR ANHYDROUS

product(s) by strength(s)

tenofovir disoproxil fumarate 0.04 mg/mg oral powder

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619580403VireadNDAGilead Sciences, Inc.2012-01-18TENOFOVIR DISOPROXIL FUMARATEORALPOWDERNDA02257733fd6418-fbdc-42ca-a50d-ce2a476a5418

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022577VIREADGILEAD SCIENCES INC2012-01-18p6043230, TREATMENT OF HIV/ TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS/ TREATMENT OF HEPATITIS B INFECTION/ TREATMENT OF HIV INFECTION IN COMBINATION WITH ONE OR MORE ADDITIONAL HIV ANTIVIRAL AGENTS/ TREATMENT OF CHRONIC HEPATITIS B IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
p5922695, TREATMENT OF HIV/ TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS/ TREATMENT OF HEPATITIS B INFECTION/ TREATMENT OF HIV INFECTION IN COMBINATION WITH ONE OR MORE ADDITIONAL HIV ANTIVIRAL AGENTS/ TREATMENT OF CHRONIC HEPATITIS B IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
p5935946, TREATMENT OF HIV/ TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS/ TREATMENT OF HEPATITIS B INFECTION/ TREATMENT OF HIV INFECTION IN COMBINATION WITH ONE OR MORE ADDITIONAL HIV ANTIVIRAL AGENTS/ TREATMENT OF CHRONIC HEPATITIS B IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER, SUBSTANCE
p5977089, TREATMENT OF HIV/ TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS/ TREATMENT OF HEPATITIS B INFECTION/ TREATMENT OF HIV INFECTION IN COMBINATION WITH ONE OR MORE ADDITIONAL HIV ANTIVIRAL AGENTS/ TREATMENT OF CHRONIC HEPATITIS B IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2017-03-24]
CLINICAL TRIAL STUDY RESULTS [2016-07-24]
NEW DOSAGE FORM [2015-01-18]
PEDIATRIC EXCLUSIVITY [2015-07-18]
PEDIATRIC EXCLUSIVITY [2017-09-24]
NEW PATIENT POPULATION [2015-08-16]
NDA022577_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022577_001RXTENOFOVIR DISOPROXIL FUMARATE (40MG/SCOOPFUL)ORALPOWDERTrue2012-01-18VIREAD

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5922695 (view patent)2017-07-25NDA022577, NDA021356, NDA021752, NDA021937, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
2p5935946 (view patent)2017-07-25NDA022577, NDA021356, NDA021752, NDA021937, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
3p5977089 (view patent)2017-07-25NDA022577, NDA021356, NDA021752, NDA021937, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
4p6043230 (view patent)2017-07-25NDA022577, NDA021356, NDA021752, NDA021937, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
133fd6418-fbdc-42ca-a50d-ce2a476a5418 (view SPL)These highlights do not include all the information needed to use VIREAD safely and effectively. See full prescribing information for VIREAD. VIREAD (tenofovir disoproxil fumarate) tablets, for oral useVIREAD (tenofovir disoproxil fumarate) powder, for oral use Initial U.S. Approval: 2001prescriptionHuman PrescriptionGilead Sciences, Inc.2015-06-0222619580403, 619580401, 619580404, 619580405, 619580406tenofovir disoproxil Oral Tablet

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