FDA.reportPublic FDA data

Application 204975

Type
ANDA
Sponsor
DR REDDYS 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
43598-247Fesoterodine fumarateFesoterodine fumarateDr.Reddy's Laboratories Inc.,ANDACurrent
43598-247Fesoterodine fumarateFesoterodine fumarateDr.Reddy's Laboratories Inc.,ANDACurrent
43598-248Fesoterodine fumarateFesoterodine fumarateDr.Reddy's Laboratories Inc.,ANDACurrent
43598-248Fesoterodine fumarateFesoterodine fumarateDr.Reddy's Laboratories Inc.,ANDACurrent
51407-661Fesoterodine fumarateFesoterodine fumarateGolden State Medical Supply, Inc.ANDACurrent
51407-662Fesoterodine fumarateFesoterodine fumarateGolden State Medical Supply, Inc.ANDACurrent