FDA.reportPublic FDA data

Application 204562

Type
ANDA
Sponsor
INVENTIA HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOLTERODINE TARTRATETOLTERODINE TARTRATECAPSULE, EXTENDED RELEASE;ORAL2MGNoNo
002TOLTERODINE TARTRATETOLTERODINE TARTRATECAPSULE, EXTENDED RELEASE;ORAL4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43975-322Tolterodine TartrateTolterodine TartrateANI Pharmaceuticals, Inc.ANDACurrent
43975-322Tolterodine TartrateTolterodine TartrateAmerigen Pharmaceuticals, Inc.ANDACurrent
43975-323Tolterodine TartrateTolterodine TartrateANI Pharmaceuticals, Inc.ANDACurrent
43975-323Tolterodine TartrateTolterodine TartrateAmerigen Pharmaceuticals, Inc.ANDACurrent