FDA.reportPublic FDA data

Application 211701

Type
ANDA
Sponsor
UNICHEM LABS 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
29300-328Solifenacin SuccinateSolifenacin SuccinateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-328Solifenacin SuccinateSolifenacin SuccinateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-328Solifenacin SuccinateSolifenacin SuccinateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-329Solifenacin SuccinateSolifenacin SuccinateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-329Solifenacin SuccinateSolifenacin SuccinateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-329Solifenacin SuccinateSolifenacin SuccinateUnichem Pharmaceuticals (USA), Inc.ANDACurrent
70518-3156Solifenacin SuccinateSolifenacin SuccinateREMEDYREPACK INC.ANDACurrent