FDA.reportPublic FDA data

Application 021004

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPIVIR-HBVLAMIVUDINESOLUTION;ORAL5MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0663EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69777SUPPL2021-12-27
69758SUPPL2021-12-27
56686SUPPL2018-12-07
56548SUPPL2018-11-23
49887SUPPL2017-09-29
49871SUPPL2017-09-28
48342SUPPL2017-05-10
48329SUPPL2017-05-09
26457SUPPL2013-12-24
35861SUPPL2013-12-23
26456SUPPL2011-01-27
14144SUPPL2011-01-24
35860SUPPL2007-10-04
4015SUPPL2007-10-04
14143SUPPL2004-12-03
4013SUPPL2004-12-02
35859SUPPL2004-09-29
4014SUPPL2004-09-29
35858SUPPL2003-12-01
26455SUPPL2003-11-25
35857SUPPL2001-08-16
21348SUPPL2001-08-16
4012SUPPL2001-08-16
41870ORIG1998-12-08
35856ORIG1998-12-08
4011ORIG1998-12-08