FDA.reportPublic FDA data

Application 207721

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATETABLET;ORAL5MGNoNo
002SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-987SolifenacinSolifenacinZydus Pharmaceuticals USA Inc.ANDACurrent
68382-988SolifenacinSolifenacinZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1604SolifenacinSolifenacinZydus Lifesciences LimitedANDACurrent
70771-1604SolifenacinSolifenacinCadila Healthcare LimitedANDACurrent
70771-1605SolifenacinSolifenacinZydus Lifesciences LimitedANDACurrent
70771-1605SolifenacinSolifenacinCadila Healthcare LimitedANDACurrent