FDA.reportPublic FDA data

Application 210224

Type
ANDA
Sponsor
ALKEM 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
63629-8867Solifenacin SuccinateSolifenacin SuccinateBryant Ranch PrepackANDACurrent
63629-8867Solifenacin SuccinateSolifenacin SuccinateBryant Ranch PrepackANDACurrent
63629-8868Solifenacin SuccinateSolifenacin SuccinateBryant Ranch PrepackANDACurrent
63629-8868Solifenacin SuccinateSolifenacin SuccinateBryant Ranch PrepackANDACurrent
63629-8869Solifenacin SuccinateSolifenacin SuccinateBryant Ranch PrepackANDACurrent
63629-8869Solifenacin SuccinateSolifenacin SuccinateBryant Ranch PrepackANDACurrent
63629-8870Solifenacin SuccinateSolifenacin SuccinateBryant Ranch PrepackANDACurrent
63629-8870Solifenacin SuccinateSolifenacin SuccinateBryant Ranch PrepackANDACurrent
67877-527Solifenacin SuccinateSolifenacin SuccinateAscend Laboratories, LLCANDACurrent
67877-527Solifenacin SuccinateSolifenacin SuccinateAscend Laboratories, LLCANDACurrent
67877-527Solifenacin SuccinateSolifenacin SuccinateAscend Laboratories, LLCANDACurrent
67877-528Solifenacin SuccinateSolifenacin SuccinateAscend Laboratories, LLCANDACurrent
67877-528Solifenacin SuccinateSolifenacin SuccinateAscend Laboratories, LLCANDACurrent
67877-528Solifenacin SuccinateSolifenacin SuccinateAscend Laboratories, LLCANDACurrent
71205-561Solifenacin SuccinateSolifenacin SuccinateProficient Rx LPANDACurrent
71205-561Solifenacin SuccinateSolifenacin SuccinateProficient Rx LPANDACurrent
71335-1729Solifenacin SuccinateSolifenacin SuccinateBryant Ranch PrepackANDACurrent
71335-1729Solifenacin SuccinateSolifenacin SuccinateBryant Ranch PrepackANDACurrent