FDA.reportPublic FDA data

Application 208740

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE;TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL200MG;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-4202Emtricitabine and Tenofovir Disoproxil Fumarateemtricitabine and tenofovir disoproxil fumarateApotex Corp.ANDACurrent
60505-4202Emtricitabine and Tenofovir Disoproxil Fumarateemtricitabine and tenofovir disoproxil fumarateApotex Corp.ANDACurrent