FDA.reportPublic FDA data

Application 204946

Type
ANDA
Sponsor
ZYDUS PHARMS

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
68382-479fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-479fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-479fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-479fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-479fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-480fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-480fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-480fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-480fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-480fesoterodine fumaratefesoterodine fumarateZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1168fesoterodine fumaratefesoterodine fumarateCadila Healthcare LimitedANDACurrent
70771-1168fesoterodine fumaratefesoterodine fumarateCadila Healthcare LimitedANDACurrent
70771-1168fesoterodine fumaratefesoterodine fumarateCadila Healthcare LimitedANDACurrent
70771-1168fesoterodine fumaratefesoterodine fumarateZydus Lifesciences LimitedANDACurrent
70771-1169fesoterodine fumaratefesoterodine fumarateCadila Healthcare LimitedANDACurrent
70771-1169fesoterodine fumaratefesoterodine fumarateCadila Healthcare LimitedANDACurrent
70771-1169fesoterodine fumaratefesoterodine fumarateCadila Healthcare LimitedANDACurrent
70771-1169fesoterodine fumaratefesoterodine fumarateZydus Lifesciences LimitedANDACurrent