abacavir Oral Tablet

Brand(s)
Ziagen
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Viiv Healthcare Company (2015-09-30)
Oldest Current Product
1998-12-29
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\ABACAVIR
FDAOB
ORAL\TABLET\ABACAVIR SULFATE
SPL Active
ORAL\TABLET, FILM COATED\ABACAVIR SULFATE
ORAL\TABLET\ABACAVIR SULFATE
SPL Moiety
ORAL\TABLET, FILM COATED\ABACAVIR
ORAL\TABLET\ABACAVIR

product(s) by strength(s)

abacavir 300 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1497020221ZiagenNDAViiv Healthcare Company1998-12-29ABACAVIR SULFATEORALTABLET, FILM COATEDNDA020977ca73b519-015a-436d-aa3c-af53492825a1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784105ANDAMylan Pharmaceuticals Inc.2012-06-19ABACAVIR SULFATEORALTABLET, FILM COATEDANDA0912945676d391-f9a4-44be-9604-954b3d8d0e2b
2317220557ANDACamber Pharmaceuticals, Inc.2013-09-18ABACAVIR SULFATEORALTABLETANDA09156044fb1e25-ad03-4a7f-9f35-2e29f5025661
3510790204ANDAMylan Institutional Inc.2012-08-01ABACAVIR SULFATEORALTABLET, FILM COATEDANDA09129480c1702a-973c-436a-90f8-69b29674dca0
4605053583ANDAApotex Corp2012-12-17ABACAVIR SULFATEORALTABLET, FILM COATEDANDA20157073ce0bc5-43e2-c57f-0a6a-bdaf9fbaa3c2
5658620073ANDAAurobindo Pharma Limited2012-12-17ABACAVIR SULFATEORALTABLET, FILM COATEDANDA0778445409c8ed-17c3-454f-bb88-d597ba8f84ec

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490905ZiagenNDARemedyrepack Inc.2013-04-08ABACAVIR SULFATEORALTABLET, FILM COATED497020221NDA020977ced433cf-2acf-47ae-9b74-69992c3bc8e0
2493490999ANDARemedyrepack Inc.2013-02-27ABACAVIR SULFATEORALTABLET, FILM COATED003784105ANDA091294d4c622c8-73ba-49b4-9ac5-81bf87702775
3521250956ANDARemedyrepack Inc.2014-05-29ABACAVIR SULFATEORALTABLET317220557ANDA091560ad60ace3-d64c-4ed7-ab0d-1d3c166357f3
4538080627ANDAState Of Florida Doh Central Pharmacy2013-01-01ABACAVIR SULFATEORALTABLET, FILM COATED003784105ANDA091294e3961e38-20d5-4014-a9d5-1ab13611abb9
5538080811ZiagenNDAState Of Florida Doh Central Pharmacy2009-07-01ABACAVIR SULFATEORALTABLET, FILM COATED001730661NDA020977ff62bcaa-a200-4ebf-a9ca-1ab2c254751c
6680840021ANDAAmerican Health Packaging2013-02-07ABACAVIR SULFATEORALTABLET, FILM COATED658620073ANDA07784401e46f58-8bda-4ff3-ab21-57d5b540d440

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA077844ABACAVIR SULFATEAUROBINDO PHARMA LTD2012-12-17ANDA077844_001
2ANDA091294ABACAVIR SULFATEMYLAN PHARMACEUTICALS INC2012-06-18ANDA091294_001
3ANDA091560ABACAVIR SULFATEHETERO LABS LTD UNIT III2013-09-13ANDA091560_001
4ANDA201570ABACAVIR SULFATEAPOTEX INC2012-12-17ANDA201570_001
5NDA020977ZIAGENVIIV HEALTHCARE CO1998-12-17p6294540, METHOD OF TREATMENT OF A PATIENT INFECTED WITH HIV, SUBSTANCEONCE 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]NDA020977_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077844_001RXABACAVIR SULFATE (EQ 300MG BASE)ORALTABLETFalseAB2012-12-17ABACAVIR SULFATE
2ANDA091294_001RXABACAVIR SULFATE (EQ 300MG BASE)ORALTABLETFalseAB2012-06-18ABACAVIR SULFATE
3ANDA091560_001RXABACAVIR SULFATE (EQ 300MG BASE)ORALTABLETFalseAB2013-09-13ABACAVIR SULFATE
4ANDA201570_001RXABACAVIR SULFATE (EQ 300MG BASE)ORALTABLETFalseAB2012-12-17ABACAVIR SULFATE
5NDA020977_001RXABACAVIR SULFATE (EQ 300MG BASE)ORALTABLETTrueAB1998-12-17ZIAGEN

patent(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
101e46f58-8bda-4ff3-ab21-57d5b540d440 (view SPL)These highlights do not include all the information needed to use abacavir sulfate safely and effectively. See full prescribing information for abacavir tablets USP.ABACAVIR Tablets USP, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-162680840021
244fb1e25-ad03-4a7f-9f35-2e29f5025661 (view SPL)These highlights do not include all the information needed to use abacavir sulfate safely and effectively. See full prescribing information for abacavir sulfate.ABACAVIR Tablets USP, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.2014-07-162317220557
35409c8ed-17c3-454f-bb88-d597ba8f84ec (view SPL)These highlights do not include all the information needed to use ABACAVIR TABLETSsafely and effectively. See full prescribing information for ABACAVIR TABLETS.ABACAVIRtablets, for oral useInitial U.S. Approval: 1998prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-10-015658620073
45676d391-f9a4-44be-9604-954b3d8d0e2b (view SPL)These highlights do not include all the information needed to use ABACAVIR TABLETS safely and effectively. See full prescribing information for ABACAVIR TABLETS. ABACAVIR tablets USP, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-09-168003784105
573ce0bc5-43e2-c57f-0a6a-bdaf9fbaa3c2 (view SPL)These highlights do not include all the information needed to use ABACAVIR TABLETS, USP safely and effectively. See full prescribing information for ABACAVIR TABLETS, USP. ABACAVIR tablets, for oral use Initial U.S. Approval: 1998prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-09-016605053583
680c1702a-973c-436a-90f8-69b29674dca0 (view SPL)These highlights do not include all the information needed to use abacavir tablets safely and effectively. See full prescribing information for abacavir tablets. Abacavir Tablets, USP for Oral UseInitial U.S. Approval: 1998prescriptionHuman PrescriptionMylan Institutional Inc.2013-10-043510790204
7ad60ace3-d64c-4ed7-ab0d-1d3c166357f3 (view SPL)These highlights do not include all the information needed to use abacavir sulfate safely and effectively. See full prescribing information for abacavir sulfate.Abacavir Tablets USP Initial U.S. Approval: 1998prescriptionHuman PrescriptionRemedyrepack Inc.2014-05-292521250956
8ca73b519-015a-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 Company2015-09-3017497020221, 497020222abacavir Oral Solution
9ced433cf-2acf-47ae-9b74-69992c3bc8e0 (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 sulfate) Tablets, for oral useZIAGEN (abacavir sulfate) Oral SolutionInitial U.S. Approval: 1998prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-081493490905
10d4c622c8-73ba-49b4-9ac5-81bf87702775 (view SPL)These highlights do not include all the information needed to use abacavir tablets safely and effectively. See full prescribing information for abacavir tablets. Abacavir Tablets, USP for Oral UseInitial U.S. Approval: 1998prescriptionHuman PrescriptionRemedyrepack Inc.2013-02-272493490999
11e3961e38-20d5-4014-a9d5-1ab13611abb9 (view SPL)These highlights do not include all the information needed to use abacavir tablets safely and effectively. See full prescribing information for abacavir tablets. Abacavir Tablets, USP for Oral UseInitial U.S. Approval: 1998prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2013-08-081538080627
12ff62bcaa-a200-4ebf-a9ca-1ab2c254751c (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 sulfate) Tablets and Oral SolutionInitial U.S. Approval: 1998prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-04-131538080811

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