FDA.reportPublic FDA data

Application 201486

Type
ANDA
Sponsor
MYLAN

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
0378-3402Tolterodine TartrateTolterodine TartrateMylan Pharmaceuticals Inc.ANDACurrent
0378-3404Tolterodine TartrateTolterodine TartrateMylan Pharmaceuticals Inc.ANDACurrent
43353-346Tolterodine TartrateTolterodine TartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-197Tolterodine TartrateTolterodine TartrateMylan Institutional Inc.ANDACurrent
51079-197Tolterodine TartrateTolterodine TartrateMylan Institutional Inc.ANDACurrent
51079-198Tolterodine TartrateTolterodine TartrateMylan Institutional Inc.ANDACurrent
51079-198Tolterodine TartrateTolterodine TartrateMylan Institutional Inc.ANDACurrent
60429-825Tolterodine TartrateTolterodine TartrateGolden State Medical Supply, Inc.ANDACurrent
60429-825Tolterodine TartrateTolterodine TartrateGolden State Medical Supply, Inc.ANDACurrent
60429-826Tolterodine TartrateTolterodine TartrateGolden State Medical Supply, Inc.ANDACurrent
60429-826Tolterodine TartrateTolterodine TartrateGolden State Medical Supply, Inc.ANDACurrent
71610-002Tolterodine TartrateTolterodine TartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent