FDA.reportPublic FDA data

Application 213858

Type
ANDA
Sponsor
AMTA

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
70436-160Tolterodine TartrateTolterodine TartrateSlate Run Pharmaceuticals, LLCANDACurrent
70436-160Tolterodine TartrateTolterodine TartrateSlate Run Pharmaceuticals, LLCANDACurrent
70436-160Tolterodine TartrateTolterodine TartrateSlate Run Pharmaceuticals, LLCANDACurrent
70436-160Tolterodine TartrateTolterodine TartrateSlate Run Pharmaceuticals, LLCANDACurrent
70436-160Tolterodine TartrateTolterodine TartrateSlate Run Pharmaceuticals, LLCANDACurrent
70436-161Tolterodine TartrateTolterodine TartrateSlate Run Pharmaceuticals, LLCANDACurrent
70436-161Tolterodine TartrateTolterodine TartrateSlate Run Pharmaceuticals, LLCANDACurrent
70436-161Tolterodine TartrateTolterodine TartrateSlate Run Pharmaceuticals, LLCANDACurrent
70436-161Tolterodine TartrateTolterodine TartrateSlate Run Pharmaceuticals, LLCANDACurrent
70436-161Tolterodine TartrateTolterodine TartrateSlate Run Pharmaceuticals, LLCANDACurrent