abacavir / Lamivudine / Zidovudine Oral Tablet

Brand(s)
Trizivir
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Viiv Healthcare Company (2015-09-30)
Oldest Current Product
2010-11-02
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ABACAVIR:LAMIVUDINE:ZIDOVUDINE
FDAOB
ORAL\TABLET\ABACAVIR SULFATE: LAMIVUDINE: ZIDOVUDINE
SPL Active
ORAL\TABLET, FILM COATED\ABACAVIR SULFATE: LAMIVUDINE: ZIDOVUDINE
ORAL\TABLET\ABACAVIR SULFATE: LAMIVUDINE: ZIDOVUDINE
SPL Moiety
ORAL\TABLET, FILM COATED\ABACAVIR: LAMIVUDINE: ZIDOVUDINE
ORAL\TABLET\ABACAVIR: LAMIVUDINE: ZIDOVUDINE

product(s) by strength(s)

abacavir 300 mg / lamivudine 150 mg / zidovudine 300 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1497020217TrizivirNDAViiv Healthcare Company2010-11-02ABACAVIR SULFATE, LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATEDNDA0212059b32f5a4-d0f7-486b-b699-8dc9202b6869

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1681800286ANDALupin Pharmaceuticals, Inc.2013-12-17ABACAVIR SULFATE, LAMIVUDINE, ZIDOVUDINEORALTABLETANDA202912f5f7c0d9-a247-4308-8269-32accc490ea6

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1538080990TrizivirNDAState Of Florida Doh Central Pharmacy2013-02-01ABACAVIR SULFATE, LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED497020217NDA0212053354e50f-4dc5-413f-b5ae-87353ab8913d

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA202912ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINELUPIN LTD2013-12-05ANDA202912_001
2NDA021205TRIZIVIRVIIV HEALTHCARE CO2000-11-14p6294540, METHOD OF TREATMENT OF A PATIENT INFECTED WITH HIV, SUBSTANCE
p6417191, TREATMENT OF HIV, SUBSTANCE
p5905082, TREATMENT OF HIV, SUBSTANCE
NDA021205_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA202912_001RXZIDOVUDINE (300MG), LAMIVUDINE (150MG), ABACAVIR SULFATE (EQ 300MG BASE)ORALTABLETFalseAB2013-12-05ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
2NDA021205_001RXLAMIVUDINE (150MG), ZIDOVUDINE (300MG), ABACAVIR SULFATE (EQ 300MG BASE)ORALTABLETTrueAB2000-11-14TRIZIVIR

patent(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13354e50f-4dc5-413f-b5ae-87353ab8913d (view SPL)These highlights do not include all the information needed to use TRIZIVIR safely and effectively. See full prescribing information for TRIZIVIR.TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine) Tablets, for oral useInitial U.S. Approval: 2000prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2014-04-242538080990
29b32f5a4-d0f7-486b-b699-8dc9202b6869 (view SPL)These highlights do not include all the information needed to use TRIZIVIR safely and effectively. See full prescribing information for TRIZIVIR.TRIZIVIR (abacavir, lamivudine, and zidovudine) tablets, for oral useInitial U.S. Approval: 2000prescriptionHuman PrescriptionViiv Healthcare Company2015-09-3016497020217
3f5f7c0d9-a247-4308-8269-32accc490ea6 (view SPL)These highlights do not include all the information needed to use ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLETS. Abacavir Sulfate, Lamivudine and Zidovudine Tablets, for oral useInitial U.S. Approval: 2000prescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.Manufacture2013-12-175681800286

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