FDA.reportPublic FDA data

Application 020857

Type
NDA
Sponsor
VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COMBIVIRLAMIVUDINE; ZIDOVUDINETABLET;ORAL150MG;300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-846COMBIVIRlamivudine and zidovudineRebel Distributors CorpNDACurrent
49702-202COMBIVIRlamivudine and zidovudineViiV Healthcare CompanyNDACurrent
49702-202COMBIVIRlamivudine and zidovudineViiV Healthcare CompanyNDACurrent
49702-202COMBIVIRlamivudine and zidovudineViiV Healthcare CompanyNDACurrent
49702-202COMBIVIRlamivudine and zidovudineViiV Healthcare CompanyNDACurrent
49702-202COMBIVIRlamivudine and zidovudineViiV Healthcare CompanyNDACurrent
50090-0610COMBIVIRlamivudine and zidovudineA-S Medication SolutionsNDACurrent
52959-546COMBIVIRlamivudine and zidovudineH.J. Harkins Company, Inc.NDACurrent
53808-0895COMBIVIRlamivudine and zidovudineState of Florida DOH Central PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58731SUPPL2019-05-15
58681SUPPL2019-05-14
54179SUPPL2018-05-14
53913SUPPL2018-05-01
48024SUPPL2017-04-14
47922SUPPL2017-04-11
47453SUPPL2017-03-03
47366SUPPL2017-02-28
13627SUPPL2015-09-29
26066SUPPL2015-09-28
13626SUPPL2011-12-02
3586SUPPL2011-11-22
35518SUPPL2010-10-12
3585SUPPL2010-10-04
13625SUPPL2009-02-04
3584SUPPL2009-02-04
41761SUPPL2007-09-24
21024SUPPL2007-09-24
21023SUPPL2007-09-24
26065SUPPL2007-05-01
13624SUPPL2007-04-25
26064SUPPL2006-11-06
13623SUPPL2006-10-26
3583SUPPL2006-07-03
13622SUPPL2006-06-28
21022SUPPL2005-01-11
35517SUPPL2004-10-04
3582SUPPL2004-10-04
35516SUPPL2004-05-27
3581SUPPL2004-05-26
35515SUPPL2002-10-08
26063SUPPL2002-10-08
35514SUPPL2002-08-09
26062SUPPL2002-08-09
13621SUPPL2002-08-09
3580SUPPL2002-08-09