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Application 021205

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIZIVIRABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINETABLET;ORALEQ 300MG BASE;150MG;300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49702-217TRIZIVIRabacavir sulfate, lamivudine, and zidovudineViiV Healthcare CompanyNDACurrent
49702-217TRIZIVIRabacavir sulfate, lamivudine, and zidovudineViiV Healthcare CompanyNDACurrent
49702-217TRIZIVIRabacavir sulfate, lamivudine, and zidovudineViiV Healthcare CompanyNDACurrent
49702-217TRIZIVIRabacavir sulfate, lamivudine, and zidovudineViiV Healthcare CompanyNDACurrent
49702-217TRIZIVIRabacavir sulfate, lamivudine, and zidovudineViiV Healthcare CompanyNDACurrent
49702-217TRIZIVIRabacavir sulfate, lamivudine, and zidovudineViiV Healthcare CompanyNDACurrent
53808-0990TRIZIVIRabacavir sulfate, lamivudine, and zidovudineState of Florida DOH Central PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66293SUPPL2021-02-18
66284SUPPL2021-02-18
58710SUPPL2019-05-15
58709SUPPL2019-05-15
58695SUPPL2019-05-14
54871SUPPL2018-07-12
53985SUPPL2018-05-03
48059SUPPL2017-04-18
47600SUPPL2017-03-20
47437SUPPL2017-03-03
47367SUPPL2017-02-28
36354SUPPL2015-10-07
4639SUPPL2015-10-02
36353SUPPL2012-05-22
4638SUPPL2012-05-22
27066SUPPL2012-03-13
36352SUPPL2012-03-12
36351SUPPL2011-11-25
27065SUPPL2011-11-22
27064SUPPL2011-05-17
4637SUPPL2011-04-04
36350SUPPL2011-04-01
27063SUPPL2010-08-10
14632SUPPL2009-04-03
4636SUPPL2009-03-11
42029SUPPL2007-07-09
42028SUPPL2007-07-09
42027SUPPL2007-07-09
42026SUPPL2007-07-09
42025SUPPL2007-07-09
42024SUPPL2007-07-09
36349SUPPL2007-05-09
27062SUPPL2007-05-09
4635SUPPL2006-08-18
36348SUPPL2006-08-14
36347SUPPL2005-05-17
27061SUPPL2005-05-17
42022SUPPL2005-04-08
42023SUPPL2005-03-08
21506SUPPL2005-03-08
36343ORIG2004-06-28
27058ORIG2004-06-28
42021ORIG2004-03-28
27059SUPPL2004-03-01
4633SUPPL2004-03-01
36346SUPPL2002-10-08
27060SUPPL2002-10-08
36345SUPPL2002-08-13
4634SUPPL2002-08-13
36344SUPPL2002-06-04
4632SUPPL2002-02-05