FDA.reportPublic FDA data

Application 021003

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EPIVIR-HBVLAMIVUDINETABLET;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0662EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0662EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0662EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0662EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0662EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0662EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0662EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0662EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
0173-0662EPIVIRlamivudineGlaxoSmithKline LLCNDACurrent
53808-0893EPIVIRlamivudineState of Florida DOH Central PharmacyNDACurrent
66993-478LamivudinelamivudinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-478LamivudinelamivudinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-478LamivudinelamivudinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-478LamivudinelamivudinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-478LamivudinelamivudinePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69776SUPPL2021-12-27
69757SUPPL2021-12-27
56685SUPPL2018-12-07
56547SUPPL2018-11-23
49888SUPPL2017-09-29
49870SUPPL2017-09-28
48340SUPPL2017-05-10
48330SUPPL2017-05-09
4010SUPPL2013-12-24
14142SUPPL2013-12-23
4009SUPPL2011-01-27
35855SUPPL2011-01-24
35854SUPPL2007-10-04
26454SUPPL2007-10-04
14141SUPPL2004-12-03
4007SUPPL2004-12-02
35853SUPPL2004-09-29
4008SUPPL2004-09-29
35852SUPPL2003-12-01
26453SUPPL2003-11-25
35851SUPPL2001-08-16
26452SUPPL2001-08-16
21347SUPPL2001-08-16
21346ORIG1998-12-08
14140ORIG1998-12-08
4006ORIG1998-12-08