tenofovir disoproxil Oral Tablet

Brand(s)
Viread
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Gilead Sciences, Inc. (2015-06-02)
Oldest Current Product
2001-10-26
License(s)
NDA, EXPORT ONLY
RxNORM
ORAL TABLET\TENOFOVIR DISOPROXIL
FDAOB
ORAL\TABLET\TENOFOVIR DISOPROXIL FUMARATE
SPL Active
ORAL\TABLET, COATED\TENOFOVIR DISOPROXIL FUMARATE
SPL Moiety
ORAL\TABLET, COATED\TENOFOVIR
ORAL\TABLET, COATED\TENOFOVIR ANHYDROUS

product(s) by strength(s)

tenofovir disoproxil fumarate 150 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619580404VireadNDAGilead Sciences, Inc.2012-01-18TENOFOVIR DISOPROXIL FUMARATEORALTABLET, COATEDNDA02135633fd6418-fbdc-42ca-a50d-ce2a476a5418

tenofovir disoproxil fumarate 200 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619580405VireadNDAGilead Sciences, Inc.2012-01-18TENOFOVIR DISOPROXIL FUMARATEORALTABLET, COATEDNDA02135633fd6418-fbdc-42ca-a50d-ce2a476a5418

tenofovir disoproxil fumarate 250 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619580406VireadNDAGilead Sciences, Inc.2012-01-18TENOFOVIR DISOPROXIL FUMARATEORALTABLET, COATEDNDA02135633fd6418-fbdc-42ca-a50d-ce2a476a5418

tenofovir disoproxil fumarate 300 mg oral tablet

export only product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1619580402VireadEXPORT ONLYGilead Sciences, Inc.2001-10-26TENOFOVIR DISOPROXIL FUMARATEORALTABLET, COATED1fdae465-2c01-4030-a73c-fd2f13368453

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619580401VireadNDAGilead Sciences, Inc.2001-10-26TENOFOVIR DISOPROXIL FUMARATEORALTABLET, COATEDNDA02135633fd6418-fbdc-42ca-a50d-ce2a476a5418

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1242360284VireadNDARemedyrepack Inc.2013-03-28TENOFOVIR DISOPROXIL FUMARATEORALTABLET, COATED619580401NDA021356c326dfca-5394-4cf9-96b9-3809ccbfccc9
2538080810VireadNDAState Of Florida Doh Central Pharmacy2009-07-01TENOFOVIR DISOPROXIL FUMARATEORALTABLET, COATED619580401NDA021356e122435e-cd0b-4c90-940a-b7a0d090d866

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA091612TENOFOVIR DISOPROXIL FUMARATETEVA PHARMACEUTICALS USA2015-03-18ANDA091612_001
2NDA021356VIREADGILEAD SCIENCES INC2001-10-26p6043230, 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
PEDIATRIC EXCLUSIVITY [2017-09-24]
PEDIATRIC EXCLUSIVITY [2015-07-18]
NEW PATIENT POPULATION [2015-01-18]
NEW PATIENT POPULATION [2015-08-16]
ORPHAN DRUG EXCLUSIVITY [2017-03-24]
CLINICAL TRIAL STUDY RESULTS [2016-07-24]
NDA021356_001, NDA021356_002, NDA021356_003, NDA021356_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA091612_001RXTENOFOVIR DISOPROXIL FUMARATE (300MG)ORALTABLETFalseAB2015-03-18TENOFOVIR DISOPROXIL FUMARATE
2NDA021356_001RXTENOFOVIR DISOPROXIL FUMARATE (300MG)ORALTABLETTrueAB2001-10-26VIREAD
3NDA021356_002RXTENOFOVIR DISOPROXIL FUMARATE (150MG)ORALTABLETFalse2012-01-18VIREAD
4NDA021356_003RXTENOFOVIR DISOPROXIL FUMARATE (200MG)ORALTABLETFalse2012-01-18VIREAD
5NDA021356_004RXTENOFOVIR DISOPROXIL FUMARATE (250MG)ORALTABLETFalse2012-01-18VIREAD

patent(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
11fdae465-2c01-4030-a73c-fd2f13368453 (view SPL)These highlights do not include all the information needed to use VIREAD safely and effectively. See full prescribing information for VIREAD. GILEAD ACCESS PROGRAM VIREAD (tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2001prescriptionHuman PrescriptionGilead Sciences, Inc.2015-05-293619580402
233fd6418-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.2015-06-0222619580401, 619580404, 619580405, 619580406, 619580403tenofovir disoproxil Oral Powder
3c326dfca-5394-4cf9-96b9-3809ccbfccc9 (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 PrescriptionRemedyrepack Inc.2013-03-283242360284
4e122435e-cd0b-4c90-940a-b7a0d090d866 (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) tablet, coated for oral useInitial U.S. Approval: 2001prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-04-131538080810

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