FDA.reportPublic FDA data

Application 203442

Type
ANDA
Sponsor
MACLEODS PHARMS 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
16714-534Emtricitabine and tenofovir disoproxil fumarateEmtricitabine and tenofovir disoproxil fumarateNorthStar RxLLCANDACurrent
16714-534Emtricitabine and tenofovir disoproxil fumarateEmtricitabine and tenofovir disoproxil fumarateNorthStar RxLLCANDACurrent
33342-106Emtricitabine and tenofovir disoproxil fumarateEmtricitabine and tenofovir disoproxil fumarateMacleods Pharmaceuticals LimitedANDACurrent
33342-106Emtricitabine and tenofovir disoproxil fumarateEmtricitabine and tenofovir disoproxil fumarateMacleods Pharmaceuticals LimitedANDACurrent
33342-106Emtricitabine and tenofovir disoproxil fumarateEmtricitabine and tenofovir disoproxil fumarateMacleods Pharmaceuticals LimitedANDACurrent