FDA.reportPublic FDA data

Application 204397

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOLTERODINE TARTRATETOLTERODINE TARTRATETABLET;ORAL1MGNoNo
002TOLTERODINE TARTRATETOLTERODINE TARTRATETABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-805Tolterodine TartrateTolterodine TartrateCamber Pharmaceuticals, Inc.ANDACurrent
31722-806Tolterodine TartrateTolterodine TartrateCamber Pharmaceuticals, Inc.ANDACurrent