emtricitabine / tenofovir disoproxil Oral Tablet

Brand(s)
Truvada
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Gilead Sciences, Inc. (2013-12-23)
Oldest Current Product
2004-08-02
License(s)
NDA, EXPORT ONLY
RxNORM
ORAL TABLET\EMTRICITABINE:TENOFOVIR DISOPROXIL
FDAOB
ORAL\TABLET\EMTRICITABINE: TENOFOVIR DISOPROXIL FUMARATE
SPL Active
ORAL\TABLET, FILM COATED\EMTRICITABINE: TENOFOVIR DISOPROXIL FUMARATE
ORAL\TABLET\EMTRICITABINE: TENOFOVIR DISOPROXIL FUMARATE
SPL Moiety
ORAL\TABLET, FILM COATED\EMTRICITABINE: TENOFOVIR
ORAL\TABLET, FILM COATED\EMTRICITABINE: TENOFOVIR ANHYDROUS
ORAL\TABLET\EMTRICITABINE: TENOFOVIR ANHYDROUS

product(s) by strength(s)

emtricitabine 200 mg / tenofovir disoproxil fumarate 300 mg oral tablet

export only product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1619580702TruvadaEXPORT ONLYGilead Sciences, Inc.2004-08-02EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATED8bd3debe-d414-450f-b8d9-a70fb1dd5341

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619580701TruvadaNDAGilead Sciences, Inc.2004-08-02EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATEDNDA02175254e82b13-a037-49ed-b4b3-030b37c0ecdd

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1529590969TruvadaNDAH.J. Harkins Company, Inc.2004-08-02EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATED619580701NDA0217527fbc31c3-48d3-4508-8717-1cdfbf085b4d
2538080805TruvadaNDAState Of Florida Doh Central Pharmacy2009-07-01EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATED619580701NDA021752d0b3d18b-7e5d-49ea-bcaf-8408414e8094
3548685141TruvadaNDAPhysicians Total Care, Inc.2004-08-02EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET, FILM COATED619580701NDA021752b34cb984-313c-4be3-b34e-90ab2797a29e
4551540082TruvadaNDACardinal Health2004-08-02EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATEORALTABLET619580701NDA021752044d9708-99f3-4a61-b314-dee76ae2e37f

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021752TRUVADAGILEAD SCIENCES INC2004-08-02p6703396, SUBSTANCE
p5814639, SUBSTANCE
p5922695, TREATMENT OF HIV/ METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1/ TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER/ PROPHYLAXIS OF HIV-1 INFECTION
p5914331, TREATMENT OF HIV, SUBSTANCE
p8592397, TREATMENT OF HIV/ METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1/ TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER, SUBSTANCE
p5977089, TREATMENT OF HIV/ METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1/ TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER/ PROPHYLAXIS OF HIV-1 INFECTION, SUBSTANCE
p6043230, TREATMENT OF HIV/ METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1/ TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER/ PROPHYLAXIS OF HIV-1 INFECTION, SUBSTANCE
p6642245, TREATMENT OF HIV/ METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1/ TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
p8716264, TREATMENT OF HIV INFECTION, SUBSTANCE
p5935946, TREATMENT OF HIV/ METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1/ TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER/ PROPHYLAXIS OF HIV-1 INFECTION, SUBSTANCE
NDA021752_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021752_001RXEMTRICITABINE (200MG), TENOFOVIR DISOPROXIL FUMARATE (300MG)ORALTABLETTrue2004-08-02TRUVADA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5814639 (view patent)2015-09-29NDA021752, NDA021500, NDA021896, NDA021937, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Solution
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
2p5914331 (view patent)2017-07-02NDA021752, NDA021500, NDA021896, NDA021937, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Solution
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
3p5922695 (view patent)2017-07-25NDA021752, NDA021356, NDA021937, NDA022577, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Powder
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
4p5935946 (view patent)2017-07-25NDA021752, NDA021356, NDA021937, NDA022577, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Powder
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
5p5977089 (view patent)2017-07-25NDA021752, NDA021356, NDA021937, NDA022577, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Powder
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
6p6043230 (view patent)2017-07-25NDA021752, NDA021356, NDA021937, NDA022577, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Powder
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
tenofovir disoproxil Oral Tablet
7p6642245 (view patent)2020-11-04NDA021752, NDA021500, NDA021896, NDA021937, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Solution
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
8p6703396 (view patent)2021-03-09NDA021752, NDA021500, NDA021896, NDA021937, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Solution
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
emtricitabine Oral Capsule
9p8592397 (view patent)2024-01-13NDA021752, NDA021937, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet
10p8716264 (view patent)2024-01-13NDA021752, NDA021937, NDA202123, NDA203100efavirenz / emtricitabine / tenofovir disoproxil Oral Tablet
cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil Oral Tablet
emtricitabine / Rilpivirine / tenofovir disoproxil Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1044d9708-99f3-4a61-b314-dee76ae2e37f (view SPL)These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA (emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionCardinal HealthREPACK2013-09-053551540082
254e82b13-a037-49ed-b4b3-030b37c0ecdd (view SPL)These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA (emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionGilead Sciences, Inc.2013-12-2319619580701
37fbc31c3-48d3-4508-8717-1cdfbf085b4d (view SPL)These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA.TRUVADA (emtricitabine/tenofovir disoproxil fumarate) tablets Initial U.S. Approval: 2004prescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-12-142529590969
48bd3debe-d414-450f-b8d9-a70fb1dd5341 (view SPL)These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA (emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2004prescriptionHuman PrescriptionGilead Sciences, Inc.2015-05-293619580702
5b34cb984-313c-4be3-b34e-90ab2797a29e (view SPL)These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA (emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-03-012548685141
6d0b3d18b-7e5d-49ea-bcaf-8408414e8094 (view SPL)These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA.TRUVADA (emtricitabine/tenofovir disoproxil fumarate) tablets Initial U.S. Approval: 2004prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-04-131538080805

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