FDA.reportPublic FDA data

Application 204131

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5957EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEA-S Medication SolutionsANDACurrent
68180-287EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATELupin Pharmaceuticals, Inc.ANDACurrent
72189-312EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEDirectRxANDACurrent