FDA.reportPublic FDA data

Application 204827

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-064Fesoterodine FumarateFesoterodine FumarateAscend Laboratories, LLCANDACurrent
67877-068Fesoterodine FumarateFesoterodine FumarateAscend Laboratories, LLCANDACurrent