abacavir Oral Solution

Brand(s)
Ziagen
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Viiv Healthcare Company (2015-09-30)
Oldest Current Product
1999-01-28
License(s)
NDA
RxNORM
ORAL SOLUTION\ABACAVIR
FDAOB
ORAL\SOLUTION\ABACAVIR SULFATE
SPL Active
ORAL\SOLUTION\ABACAVIR SULFATE
SPL Moiety
ORAL\SOLUTION\ABACAVIR

product(s) by strength(s)

abacavir 20 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1497020222ZiagenNDAViiv Healthcare Company1999-01-28ABACAVIR SULFATEORALSOLUTIONNDA020978ca73b519-015a-436d-aa3c-af53492825a1

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA020978ZIAGENVIIV HEALTHCARE CO1998-12-17p6294540, METHOD OF TREATMENT OF A PATIENT INFECTED WITH HIV, SUBSTANCE
p6641843, 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]NDA020978_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020978_001RXABACAVIR SULFATE (EQ 20MG BASE/ML)ORALSOLUTIONTrue1998-12-17ZIAGEN

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6294540 (view patent)2018-05-14NDA020978, NDA020977, NDA021205, NDA021652, NDA205551abacavir / Lamivudine Oral Tablet
abacavir / dolutegravir / Lamivudine Oral Tablet
abacavir / Lamivudine / Zidovudine Oral Tablet
abacavir Oral Tablet
2p6641843 (view patent)2019-02-04NDA020978

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
1ca73b519-015a-436d-aa3c-af53492825a1 (view SPL)These highlights do not include all the information needed to use ZIAGEN safely and effectively. See full prescribing information for ZIAGEN. ZIAGEN (abacavir) tablets, for oral useZIAGEN (abacavir) oral solutionInitial U.S. Approval: 1998prescriptionHuman PrescriptionViiv Healthcare Company2015-09-3017497020222, 497020221abacavir Oral Tablet

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