Application 206817

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
65862-878Solifenacin SuccinateSolifenacin SuccinateAurobindo Pharma LimitedANDACurrent
65862-879Solifenacin SuccinateSolifenacin SuccinateAurobindo Pharma LimitedANDACurrent