Lamivudine / Zidovudine Oral Tablet

Brand(s)
Combivir
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Viiv Healthcare Company (2015-09-28)
Oldest Current Product
1997-09-30
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\LAMIVUDINE:ZIDOVUDINE
FDAOB
ORAL\TABLET\LAMIVUDINE: ZIDOVUDINE
SPL Active
ORAL\TABLET, FILM COATED\LAMIVUDINE: ZIDOVUDINE
ORAL\TABLET\LAMIVUDINE: ZIDOVUDINE
SPL Moiety
ORAL\TABLET, FILM COATED\LAMIVUDINE: ZIDOVUDINE
ORAL\TABLET\LAMIVUDINE: ZIDOVUDINE

product(s) by strength(s)

lamivudine 150 mg / zidovudine 300 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1497020202CombivirNDAViiv Healthcare Company2010-10-19LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATEDNDA02085716da660b-9981-4d24-a14a-94c7744fce4f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935385ANDATeva Pharmaceuticals Usa Inc2011-12-27LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATEDANDA079081221a4135-70e1-4913-bd54-f4b84bb4001b
2003785180ANDAMylan Pharmaceuticals Inc.2014-09-30LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATEDANDA2040054d7df84d-256e-48c9-b164-254d5bce1eb7
3317220506ANDACamber Pharmaceuticals, Inc.2015-09-18LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATEDANDA079124f80bd0f3-47eb-4b82-a633-4536cf376cf6
4317220739ANDACamber Pharmaceuticals, Inc.2014-02-06LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATEDANDA203259e816e8f5-1e50-4f49-8bea-92da0121d26e
5643800707ANDAStrides Arcolab Limited2014-05-13LAMIVUDINE, ZIDOVUDINEORALTABLETANDA079128c1caff4e-a424-40d1-9853-4f0c6b0d0dce
6658620597ANDAAurobindo Pharma Limited2012-05-15LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATEDANDA2024181a123145-2d63-484a-a0a0-061890796137
7681800284ANDALupin Pharmaceuticals, Inc.2012-05-14LAMIVUDINE, ZIDOVUDINEORALTABLETANDA090246da2d3a56-a124-46cd-93bf-82b3c419536b
8762820115ANDAExelan Pharmaceuticals Inc.2015-04-29LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATEDANDA2032594cf565c3-bdec-4c18-93c1-cc7fa8331c90

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900061CombivirNDAStat Rx Usa Llc1997-09-30LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED001730595NDA020857b03e286a-4d44-489a-89d0-ee563e1f280f
2216950846CombivirNDARebel Distributors Corp1997-09-30LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED001730595NDA020857d8540843-055c-47fb-9cff-81e64b1d41c3
3216950996ANDARebel Distributors Corp2011-12-27LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED000935385ANDA079081d346d08d-ebb5-4500-923f-fe111f304876
4422910363ANDAAvkare, Inc.2013-10-16LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED000935385ANDA079081633ac0f4-576f-b556-650b-a5e7af39b4ad
5430630346ANDAPd-Rx Pharmaceuticals, Inc.2011-12-27LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED000935385ANDA0790810bdae7bd-2d03-4948-baa3-73532602b2ef
6493490683CombivirNDARemedyrepack Inc.2013-04-23LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED497020202NDA02085756467b20-c2c0-416a-8e6e-931bac559f7f, 64b73211-b156-4a8b-b6f6-4b97f82bfc43, 8381ce12-92fa-4cab-b45f-f65ed3d0197b
7504360597ANDAUnit Dose Services2012-05-15LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED658620597ANDA202418abd503f4-6de8-41e2-95fa-2496610508ad
8529590546CombivirNDAH.J. Harkins Company, Inc.2010-10-19LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED497020202NDA020857479a2784-8db2-4fe5-94ba-55316a3c4e4f
9538080895CombivirNDAState Of Florida Doh Central Pharmacy2014-01-01LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED497020202NDA0208571bc4c6c8-7e75-494e-810b-8f83135a3204
10607600385ANDASt Marys Medical Park Pharmacy2012-08-29LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED000935385ANDA07908198dfecf6-dbaf-4ef5-9fda-d11f90f6aa58
11619190061ANDADirect Rx2015-01-01LAMIVUDINE, ZIDOVUDINEORALTABLET658620597ANDA20241877eccfa0-c03c-49a3-bfa7-f31888d77161
12636294872ANDABryant Ranch Prepack2012-05-15LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED658620597ANDA20241890355e89-87d0-456a-87c1-c25bae12affc
13680840416ANDAAmerican Health Packaging2014-02-20LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED658620597ANDA202418d9370dfc-283b-4a91-8e5e-18c35d2a78e6
14765191005ANDAH.J. Harkins Company, Inc.2011-12-27LAMIVUDINE, ZIDOVUDINEORALTABLET, FILM COATED000935385ANDA079081fc2d6065-7806-457c-82e1-04bb19e57b8c

application(s)

#idtitleapplicantapprovedpatentapproved drugin other drug docs
1ANDA079081LAMIVUDINE AND ZIDOVUDINETEVA PHARMACEUTICALS USA2011-05-25ANDA079081_001Lamivudine Oral Tablet
2ANDA079124LAMIVUDINE AND ZIDOVUDINEHETERO LABS LTD UNIT III2015-09-17ANDA079124_001Lamivudine Oral Tablet
3ANDA079128LAMIVUDINE AND ZIDOVUDINESTRIDES PHARMA GLOBAL PTE LTD2015-05-13ANDA079128_001Lamivudine Oral Tablet
4ANDA090246LAMIVUDINE AND ZIDOVUDINELUPIN LTD2012-05-15ANDA090246_001Lamivudine Oral Tablet
5ANDA202418LAMIVUDINE AND ZIDOVUDINEAUROBINDO PHARMA LTD2012-05-15ANDA202418_001Lamivudine Oral Tablet
6ANDA203259LAMIVUDINE AND ZIDOVUDINEHETERO LABS LTD UNIT V2014-02-03ANDA203259_001Lamivudine Oral Tablet
7ANDA204005LAMIVUDINE AND ZIDOVUDINEMYLAN PHARMACEUTICALS INC2014-08-28ANDA204005_001Lamivudine Oral Tablet
8NDA020857COMBIVIRVIIV HEALTHCARE CO1997-09-26p5905082, TREATMENT OF HIV, SUBSTANCENDA020857_001Lamivudine Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA079081_001RXLAMIVUDINE (150MG), ZIDOVUDINE (300MG)ORALTABLETFalseAB2011-05-25LAMIVUDINE AND ZIDOVUDINE
2ANDA079124_001RXZIDOVUDINE (300MG), LAMIVUDINE (150MG)ORALTABLETFalseAB2015-09-17LAMIVUDINE AND ZIDOVUDINE
3ANDA079128_001RXLAMIVUDINE (150MG), ZIDOVUDINE (300MG)ORALTABLETFalseAB2015-05-13LAMIVUDINE AND ZIDOVUDINE
4ANDA090246_001RXZIDOVUDINE (300MG), LAMIVUDINE (150MG)ORALTABLETFalseAB2012-05-15LAMIVUDINE AND ZIDOVUDINE
5ANDA202418_001RXZIDOVUDINE (300MG), LAMIVUDINE (150MG)ORALTABLETFalseAB2012-05-15LAMIVUDINE AND ZIDOVUDINE
6ANDA203259_001RXZIDOVUDINE (300MG), LAMIVUDINE (150MG)ORALTABLETFalseAB2014-02-03LAMIVUDINE AND ZIDOVUDINE
7ANDA204005_001RXLAMIVUDINE (150MG), ZIDOVUDINE (300MG)ORALTABLETFalseAB2014-08-28LAMIVUDINE AND ZIDOVUDINE
8NDA020857_001RXZIDOVUDINE (300MG), LAMIVUDINE (150MG)ORALTABLETTrueAB1997-09-26COMBIVIR

patent(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10bdae7bd-2d03-4948-baa3-73532602b2ef (view SPL)These highlights do not include all the information needed to use lamivudine and zidovudine tablets USP safely and effectively. See full prescribing information for lamivudine and zidovudine tablets USP.LAMIVUDINE and ZIDOVUDINE tablets, USP 150 mg/300 mg for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-12-231430630346
216da660b-9981-4d24-a14a-94c7744fce4f (view SPL)These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR.COMBIVIR (lamivudine and zidovudine) tabletsInitial U.S. Approval: 1997prescriptionHuman PrescriptionViiv Healthcare Company2015-09-2810497020202
31a123145-2d63-484a-a0a0-061890796137 (view SPL)These highlights do not include all the information needed to use lamivudine and zidovudine safely and effectively. See full prescribing information for lamivudine and zidovudine tablets USP. Lamivudine and Zidovudine Tablets USPInitial U.S. Approval: 1997prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, MANUFACTURE2012-05-151658620597
41bc4c6c8-7e75-494e-810b-8f83135a3204 (view SPL)These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR.COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mgInitial U.S. Approval: 1997prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2014-02-271538080895
5221a4135-70e1-4913-bd54-f4b84bb4001b (view SPL)These highlights do not include all the information needed to use LAMIVUDINE AND ZIDOVUDINE TABLETS USP safely and effectively. See full prescribing information for LAMIVUDINE AND ZIDOVUDINE TABLETS USP.LAMIVUDINE and ZIDOVUDINE tablets 150 mg/300 mg, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-11-034000935385
6479a2784-8db2-4fe5-94ba-55316a3c4e4f (view SPL)These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR.COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mgInitial U.S. Approval: 1997prescriptionHuman PrescriptionH.J. Harkins Company, Inc.relabel, repack2012-02-021529590546
74cf565c3-bdec-4c18-93c1-cc7fa8331c90 (view SPL)These highlights do not include all the information needed to use lamivudine and zidovudine safely and effectively. See full prescribing information for lamivudine and zidovudine. Lamivudine and Zidovudine Tablets, USP Initial U.S. Approval: 1997prescriptionHuman PrescriptionExelan Pharmaceuticals Inc.analysis, manufacture2015-04-291762820115
84d7df84d-256e-48c9-b164-254d5bce1eb7 (view SPL)These highlights do not include all the information needed to use LAMIVUDINE and ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE and ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets USP, for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-10-064003785180
956467b20-c2c0-416a-8e6e-931bac559f7f (view SPL)These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR.COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mgInitial U.S. Approval: 1997prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-231493490683
10633ac0f4-576f-b556-650b-a5e7af39b4ad (view SPL)These highlights do not include all the information needed to use lamivudine and zidovudine tablets USP safely and effectively. See full prescribing information for lamivudine and zidovudine tablets USP.LAMIVUDINE and ZIDOVUDINE tablets, USP 150 mg/300 mg for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionAvkare, Inc.2013-10-161422910363
1164b73211-b156-4a8b-b6f6-4b97f82bfc43 (view SPL)These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR.COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mgInitial U.S. Approval: 1997prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-231493490683
1277eccfa0-c03c-49a3-bfa7-f31888d77161 (view SPL)Lamivudine ZidovudineprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-08-041619190061
138381ce12-92fa-4cab-b45f-f65ed3d0197b (view SPL)These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR.COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mgInitial U.S. Approval: 1997prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-231493490683
1490355e89-87d0-456a-87c1-c25bae12affc (view SPL)These highlights do not include all the information needed to use lamivudine and zidovudine safely and effectively. See full prescribing information for lamivudine and zidovudine tablets USP. Lamivudine and Zidovudine Tablets USPInitial U.S. Approval: 1997prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-101001636294872
1598dfecf6-dbaf-4ef5-9fda-d11f90f6aa58 (view SPL)These highlights do not include all the information needed to use lamivudine and zidovudine tablets USP safely and effectively. See full prescribing information for lamivudine and zidovudine tablets USP.LAMIVUDINE and ZIDOVUDINE tablets, USP 150 mg/300 mg for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionSt Marys Medical Park PharmacyManufacture, relabel, repack2012-08-291607600385
16abd503f4-6de8-41e2-95fa-2496610508ad (view SPL)These highlights do not include all the information needed to use lamivudine and zidovudine safely and effectively. See full prescribing information for lamivudine and zidovudine tablets USP. Lamivudine and Zidovudine Tablets USP Initial U.S. Approval: 1997prescriptionHuman PrescriptionUnit Dose ServicesREPACK2012-05-152504360597
17b03e286a-4d44-489a-89d0-ee563e1f280f (view SPL)COMBIVIR (lamivudine and zidovudine) tablet, film coatedprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-271165900061
18c1caff4e-a424-40d1-9853-4f0c6b0d0dce (view SPL)These highlights do not include all the information needed to use Lamivudine and Zidovudine tablets, USP safely and effectively. See full prescribing information for Lamivudine and Zidovudine tablets, USP [150/300 mg] Lamivudine and Zidovudine tablets, USP [150/300 mg] for oral use.Initial U.S. Approval: 1997prescriptionHuman PrescriptionStrides Arcolab Limitedanalysis, manufacture2014-05-311643800707
19d346d08d-ebb5-4500-923f-fe111f304876 (view SPL)These highlights do not include all the information needed to use lamivudine and zidovudine tablets USP safely and effectively. See full prescribing information for lamivudine and zidovudine tablets USP.LAMIVUDINE and ZIDOVUDINE tablets, USP 150 mg/300 mg for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-04-041216950996
20d8540843-055c-47fb-9cff-81e64b1d41c3 (view SPL)These highlights do not include all the information needed to use COMBIVIR safely and effectively. See full prescribing information for COMBIVIR.COMBIVIR (lamivudine and zidovudine) Tablets 150 mg/300 mgInitial U.S. Approval: 1997prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-241216950846
21d9370dfc-283b-4a91-8e5e-18c35d2a78e6 (view SPL)These highlights do not include all the information needed to use lamivudine and zidovudine safely and effectively. See full prescribing information for lamivudine and zidovudine tablets USP. Lamivudine and Zidovudine Tablets USP Initial U.S. Approval: 1997prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-07-293680840416
22da2d3a56-a124-46cd-93bf-82b3c419536b (view SPL)These highlights do not include all the information needed to use Lamivudine and Zidovudine Tablets safely and effectively. See full prescribing information for Lamivudine and Zidovudine Tablets. Lamivudine and Zidovudine Tablets USP, 150 mg/300 mg Initial U.S. Approval: 1997prescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.2014-08-015681800284
23e816e8f5-1e50-4f49-8bea-92da0121d26e (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use lamivudine andzidovudine safely andeffectively. See full prescribing information for lamivudineandzidovudine.Lamivudine and Zidovudine Tablets, USPInitial U.S. Approval: 1997prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.2014-02-061317220739
24f80bd0f3-47eb-4b82-a633-4536cf376cf6 (view SPL)These highlights do not include all the information needed to use lamivudine and zidovudine tablet safely and effectively. See full prescribing information for lamivudine and zidovudine tablet. LAMIVUDINE and ZIDOVUDINE tablets USP, 150 mg/300 mg for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2015-09-181317220506
25fc2d6065-7806-457c-82e1-04bb19e57b8c (view SPL)These highlights do not include all the information needed to use lamivudine and zidovudine tablets USP safely and effectively. See full prescribing information for lamivudine and zidovudine tablets USP.LAMIVUDINE and ZIDOVUDINE tablets, USP 150 mg/300 mg for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionH.J. Harkins Company, Inc.relabel, repack2012-06-251765191005

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