abacavir / Lamivudine Oral Tablet

Brand(s)
Epzicom
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Viiv Healthcare Company (2015-09-17)
Oldest Current Product
2006-05-22
License(s)
NDA
RxNORM
ORAL TABLET\ABACAVIR:LAMIVUDINE
FDAOB
ORAL\TABLET\ABACAVIR SULFATE: LAMIVUDINE
SPL Active
ORAL\TABLET, FILM COATED\ABACAVIR SULFATE: LAMIVUDINE
SPL Moiety
ORAL\TABLET, FILM COATED\ABACAVIR: LAMIVUDINE

product(s) by strength(s)

abacavir 600 mg / lamivudine 300 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1497020206EpzicomNDAViiv Healthcare Company2010-10-12ABACAVIR SULFATE, LAMIVUDINEORALTABLET, FILM COATEDNDA021652f1139e7f-2db9-4961-9da3-9b7f2088736f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1538080767EpzicomNDAState Of Florida Doh Central Pharmacy2009-07-01ABACAVIR SULFATE, LAMIVUDINEORALTABLET, FILM COATED001730742NDA021652e0fc8605-1d64-41ab-af7e-bcf66a57c1fd
2548685600EpzicomNDAPhysicians Total Care, Inc.2006-05-22ABACAVIR SULFATE, LAMIVUDINEORALTABLET, FILM COATED00173074200NDA021652080e3423-5962-4465-8e78-cd8793699336

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021652EPZICOMVIIV HEALTHCARE CO2004-08-02p6294540, TREATMENT OF HIV INFECTION, SUBSTANCE
p6417191, TREATMENT OF HIV INFECTION, SUBSTANCE
p5905082, SUBSTANCE
NDA021652_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021652_001RXLAMIVUDINE (300MG), ABACAVIR SULFATE (EQ 600MG BASE)ORALTABLETTrue2004-08-02EPZICOM

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5905082 (view patent)2016-05-18NDA021652, NDA020564, NDA020596, NDA020857, NDA021003, NDA021205, NDA205551abacavir / dolutegravir / Lamivudine Oral Tablet
abacavir / Lamivudine / Zidovudine Oral Tablet
Lamivudine Oral Tablet
Lamivudine / Zidovudine Oral Tablet
Lamivudine Oral Solution
2p6294540 (view patent)2018-05-14NDA021652, NDA020977, NDA020978, NDA021205, NDA205551abacavir / dolutegravir / Lamivudine Oral Tablet
abacavir / Lamivudine / Zidovudine Oral Tablet
abacavir Oral Solution
abacavir Oral Tablet
3p6417191 (view patent)2016-03-28NDA021652, NDA021205, NDA205551abacavir / dolutegravir / Lamivudine Oral Tablet
abacavir / Lamivudine / Zidovudine Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1080e3423-5962-4465-8e78-cd8793699336 (view SPL)EPZICOM (abacavir sulfate and lamivudine)TabletsprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-07-011548685600
2e0fc8605-1d64-41ab-af7e-bcf66a57c1fd (view SPL)EPZICOM (abacavir sulfate and lamivudine)TabletsprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-112538080767
3f1139e7f-2db9-4961-9da3-9b7f2088736f (view SPL)These highlights do not include all the information needed to use EPZICOM safely and effectively. See full prescribing information for EPZICOM.EPZICOM (abacavir sulfate and lamivudine) tablets, for oral useInitial U.S. Approval: 2004prescriptionHuman PrescriptionViiv Healthcare Company2015-09-1715497020206

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