FDA.reportPublic FDA data

Application 209818

Type
ANDA
Sponsor
BRECKENRIDGE

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
51991-893Solifenacin SuccinateSolifenacin SuccinateBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-894Solifenacin SuccinateSolifenacin SuccinateBreckenridge Pharmaceutical, Inc.ANDACurrent