Lamivudine Oral Solution

Brand(s)
Epivir, Epivir HBV
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Viiv Healthcare Company (2015-09-30)
Oldest Current Product
1998-12-23
License(s)
NDA, ANDA
RxNORM
ORAL SOLUTION\LAMIVUDINE
FDAOB
ORAL\SOLUTION\LAMIVUDINE
SPL Active
ORAL\SOLUTION\LAMIVUDINE
SPL Moiety
ORAL\SOLUTION\LAMIVUDINE

product(s) by strength(s)

lamivudine 10 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1497020205EpivirNDAViiv Healthcare Company2010-10-04LAMIVUDINEORALSOLUTIONNDA02059689226149-47fa-4f7d-bb1f-1aa7034486b8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1548380566ANDASilarx Pharmaceuticals, Inc2014-01-30LAMIVUDINEORALSOLUTIONANDA2035645b7ad852-94ff-4e8c-b53e-793a4c0a9db4

lamivudine 5 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730663Epivir HBVNDAGlaxosmithkline Llc1998-12-23LAMIVUDINEORALSOLUTIONNDA0210042df7349c-f5d7-47b5-d29b-1b6b31985591

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA203564LAMIVUDINESILARX PHARMACEUTICALS INC2014-10-31PATENT CHALLENGE [2015-09-01]ANDA203564_001
2NDA020596EPIVIRVIIV HEALTHCARE CO1995-11-17p6004968, TREATMENT OF HIV, SUBSTANCE
p5905082, SUBSTANCE
ONCE DAILY DOSING IN PEDIATRIC PATIENTS 3 MONTHS OF AGE AND OLDER IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION [2018-03-23]NDA020596_001
3NDA021004EPIVIR-HBVGLAXOSMITHKLINE1998-12-08p6004968NDA021004_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA203564_001RXLAMIVUDINE (10MG/ML)ORALSOLUTIONFalseAA2014-10-31LAMIVUDINE
2NDA020596_001RXLAMIVUDINE (10MG/ML)ORALSOLUTIONTrueAA1995-11-17EPIVIR
3NDA021004_001RXLAMIVUDINE (5MG/ML)ORALSOLUTIONTrue1998-12-08EPIVIR-HBV

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5905082 (view patent)2016-05-18NDA020596, NDA020564, NDA020857, NDA021003, NDA021205, NDA021652, NDA205551abacavir / Lamivudine Oral Tablet
abacavir / dolutegravir / Lamivudine Oral Tablet
abacavir / Lamivudine / Zidovudine Oral Tablet
Lamivudine Oral Tablet
Lamivudine / Zidovudine Oral Tablet
2p6004968 (view patent)2018-03-20NDA020596, NDA021004

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
12df7349c-f5d7-47b5-d29b-1b6b31985591 (view SPL)These highlights do not include all the information needed to use EPIVIR-HBV safely and effectively. See full prescribing information for EPIVIR-HBV.EPIVIR-HBV (lamivudine) tablets for oral useEPIVIR-HBV (lamivudine) oral solutionInitial U.S. Approval: 1995prescriptionHuman PrescriptionGlaxosmithkline Llc2013-12-2014001730663, 001730662Lamivudine Oral Tablet
25b7ad852-94ff-4e8c-b53e-793a4c0a9db4 (view SPL)These highlights do not include all the information needed to use LAMIVUDINE Oral Solution, USP safely and effectively. See full prescribing information for LAMIVUDINE Oral Solution, USP LAMIVUDINE Oral Solution, USP for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionSilarx Pharmaceuticals, Incmanufacture2014-11-114548380566
389226149-47fa-4f7d-bb1f-1aa7034486b8 (view SPL)These highlights do not include all the information needed to use EPIVIR safely and effectively. See full prescribing information for EPIVIR.EPIVIR (lamivudine) tablets for oral useEPIVIR (lamivudine) oral solutionInitial U.S. Approval: 1995prescriptionHuman PrescriptionViiv Healthcare Company2015-09-3011497020205, 497020203, 497020204Lamivudine Oral Tablet

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