FDA.reportPublic FDA data

Application 211284

Type
NDA
Sponsor
CELLTRION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMIXYSLAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL300MG;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
32228-004TEMIXYSlamivudine and tenofovir disoproxil fumarateCELLTRION, INC.NDACurrent
72606-002TEMIXYSlamivudine and tenofovir disoproxil fumarateCELLTRION USA, INC.NDACurrent
72606-002TEMIXYSlamivudine and tenofovir disoproxil fumarateCELLTRION USA, INC.NDACurrent
72606-002TEMIXYSlamivudine and tenofovir disoproxil fumarateCELLTRION USA, INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60736SUPPL2019-10-30
60723SUPPL2019-10-30
58299SUPPL2019-04-12
56750ORIG2018-12-17
56521ORIG2018-11-20
56513ORIG2018-11-20
63115ORIG1900-01-01
63114ORIG1900-01-01