FDA.reportPublic FDA data

Application 210582

Type
ANDA
Sponsor
CELLTRION

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
72606-009solifenacin succinatesolifenacin succinateCELLTRION USA, INC.ANDACurrent
72606-009solifenacin succinatesolifenacin succinateCELLTRION USA, INC.ANDACurrent
72606-009solifenacin succinatesolifenacin succinateCELLTRION USA, INC.ANDACurrent
72606-010solifenacin succinatesolifenacin succinateCELLTRION USA, INC.ANDACurrent
72606-010solifenacin succinatesolifenacin succinateCELLTRION USA, INC.ANDACurrent
72606-010solifenacin succinatesolifenacin succinateCELLTRION USA, INC.ANDACurrent