FDA.reportPublic FDA data

Application 212114

Type
ANDA
Sponsor
LAURUS LABS 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
0904-7172Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateMajor PharmaceuticalsANDACurrent
0904-7172Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateMajor PharmaceuticalsANDACurrent
42385-913Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateLaurus Labs LimitedANDACurrent
42385-913Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateLaurus Labs LimitedANDACurrent
42385-953Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil FumarateLaurus Labs LimitedANDACurrent