FDA.reportPublic FDA data

Application 205002

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FESOTERODINE FUMARATEFESOTERODINE FUMARATETABLET, FOR SUSPENSION;ORAL4MGNoNo
002FESOTERODINE FUMARATEFESOTERODINE FUMARATETABLET, FOR SUSPENSION;ORAL8MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-369Fesoterodine FumarateFesoterodine FumarateAmneal Pharmaceuticals LLCANDACurrent
65162-370Fesoterodine FumarateFesoterodine FumarateAmneal Pharmaceuticals LLCANDACurrent