Application 213346

Type
ANDA
Sponsor
SUNSHINE LAKE

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
48792-7909solifenacin succinatesolifenacin succinateSunshine Lake Pharma Co., Ltd.ANDACurrent
48792-7910solifenacin succinatesolifenacin succinateSunshine Lake Pharma Co., Ltd.ANDACurrent